COPD World News     Week of June 27, 2010

COPD Care Fails to Match Guidelines

Springfield, MA - Most people getting inpatient care for exacerbations of chronic obstructive pulmonary disease are initially treated with high-dose intravenous corticosteroids, clinical guidelines to the contrary, researchers found.

In a cohort study of nearly 80,000 patients, 92% were given IV steroids and only 8% were initially treated with low-dose oral medications as guidelines urge, according to Peter Lindenauer, MD, of Baystate Medical Center in Springfield, Mass., and colleagues. But the risk of treatment failure with low-dose steroids was no greater, and costs were lower and hospital stays were shorter, the researchers reported in the Journal of the American Medical Association.

The findings have a "significant potential to alter practice, potentially reducing costs, complications, and lowering the risks of steroid-associated adverse events," the researchers concluded. Clinical trials have shown that systemic corticosteroids improve outcomes in patients who need inpatient care for exacerbations of COPD, which amounted to about 600,000 admissions in 2006. But the best dose and route of administration remains uncertain, although clinical guidelines from professional societies in Europe and the U.S. suggest low-dose oral medications.

To help fill the gap, the researchers conducted a pharmacoepidemiological cohort study using registry data from 414 U.S. hospitals and involving 79,985 patients admitted with acute exacerbation of COPD in 2006 and 2007 who received systemic corticosteroids during the first two hospital days. The primary outcome was treatment failure, defined as a composite including initiation of mechanical ventilation after the second hospital day, inhospital death, or readmission for COPD exacerbation within 30 days of discharge. Because mechanical ventilation was part of the endpoint, patients admitted directly to intensive care were excluded from the analysis.

The analysis showed that 73,765 patients were initially treated with intravenous steroids and 6,220 received oral treatment. But there was no statistical difference in results: 10.9% of the IV-treated and 10.3% of the orally treated patients experienced the composite outcome and the 95% confidence intervals overlapped. Lindenauer and colleagues said the intravenous approach "does not appear to be associated with any measurable clinical benefit and at the same time exposes patients to the risks and inconvenience of an intravenous line, potentially unnecessarily high doses of steroids, greater hospital costs, and longer lengths of stay.

"They cautioned that the study is observational and noted that a major limitation is that it excluded patients admitted directly to intensive care and so can't be generalized to all patients. On the other hand "the data are sufficient to take action to change practice now," argued Jerry Krishnan, MD, PhD, of the University of Chicago, and Richard Mularski, MD, of Kaiser Permanente and Oregon Health and Science University in Portland.

"Caution should be exercised when advocating a change in clinical practice based on observational research," they said in an accompanying editorial, but the other way forward -- a clinical trial comparing the two approaches -- would require too many patients and take too long to be practical. On the other hand, they said, "given that current practice overwhelmingly favors high-dose intravenous corticosteroids, facilitating change will be daunting."

For more information:

COPD World News     Week of June 20, 2010

Secondhand Smoke Ups Risk of Mental Illness

London, UK - Healthy adults exposed to secondhand smoke appear to be at higher risk of suffering psychological distress and future psychiatric illness requiring hospitalization, according to a major Scottish population study. 

The study, which tracked more than 8,000 adults over six years found that nonsmokers exposed to high levels of secondhand smoke, as measured by salivary levels of the nicotine breakdown product cotinine, were at a 49% higher adjusted risk of psychological distress compared with nonsmokers who had undetectable salivary levels of cotinine, according to the report published in the Archives of General Psychiatry. High exposure to secondhand smoke raised the risk of future hospitalization for psychiatric treatment nearly threefold for nonsmokers exposed to high levels of secondhand smoke and nearly four-fold for smokers, after adjustment for multiple variables.

In the U.S., an estimated 60% of nonsmokers have some biological evidence of exposure to secondhand smoke. "Even a low level of risk may have a major public health impact," Mark Hamer, PhD, of University College London, and colleagues wrote.

Among the entire study cohort, 14.5% of smokers and nonsmokers reported psychological distress. "We found a robust dose-response association between objectively assessed nicotine exposure and psychological distress, which was apparent at low levels of secondhand smoke exposure and was strongest in current smokers," the authors commented. "This association was replicated in prospective analyses that demonstrated an association between secondhand smoke exposure, active smoking, and risk of psychiatric episodes over six years of follow-up." Hamer and colleagues noted that a growing body of research has linked secondhand smoke with adverse effects on physical health, but much of this evidence is based on crude, self-report measures, such as exposure in the workplace or through family members who smoke.

"Recent studies using valid objective biochemical markers of secondhand smoke have reported associations with various health outcomes, including markers of inflammation, glucose control, and cardiovascular disease risk," the authors noted. "There is, however, very limited information on the association between objectively assessed secondhand smoke exposure and mental health in humans."

Animal data suggest that tobacco may induce negative mood, and some human studies have identified a potential association between smoking and depression. "The prospective nature of our study adds considerably to the current evidence base," the authors wrote. "In our analyses, the association between nicotine exposure and risk of psychiatric events persisted despite adjustment for psychological distress at baseline, which was in itself strongly associated with psychiatric admissions."

The authors cautioned that although they collected data on psychological distress using the questionnaire, they did not account for cases of psychiatric illness that may have required treatment but not hospitalization. They also noted that they did not collect follow-up measurements of cotinine levels and were thus unable to objectively assess participants' changes in smoking status.

For more information:

COPD World News     Week of June 13, 2010

Early Antibiotics Help Hospitalized COPD Patients

Springfield, MA - Initiating antibiotics within two days after patients are hospitalized for exacerbations of acute chronic obstructive pulmonary disease (COPD) appears to be associated with improved outcomes, a large retrospective cohort study showed.

The study of more than 84,000 COPD patients found those who received early antibiotic treatment had significantly lower odds of treatment failure, defined as a composite of in-hospital mortality, mechanical ventilation after the second day in the hospital, or 30-day readmission for a COPD exacerbation, according to Michael Rothberg, MD, MPH, of Baystate Medical Center in Springfield, Mass., and colleagues. The apparent benefits were consistent across patient subgroups, the researchers reported in the Journal of the American Medical Association.

Allergic reactions were not increased in the antibiotic treated group, although the rate of readmission for Clostridium difficile infection was slightly higher. "These two findings, that all patient groups seemed to benefit from therapy and that harms were minimal, support the notion that all patients hospitalized with acute exacerbations of COPD should be prescribed antibiotics," Rothberg and his colleagues wrote.

While the authors acknowledged that about 50% of COPD exacerbations are not caused by a bacterial infection, in the absence of a dependable way to identify those with a bacterial etiology, they wrote, "routine use of antibiotics for acute exacerbations of COPD may be appropriate."

Guidelines recommend antibiotic therapy for acute COPD exacerbations in patients with purulent sputum and either an increase in sputum production or an increase in dyspnea, but evidence to support this strategy is lacking, according to the authors. "Our results do not support restriction of antibiotics to hospitalized patients with purulent sputum and increased sputum production or dyspnea," they wrote.

Commenting on the study, Len Horovitz, MD, a pulmonary specialist at Lenox Hill Hospital in New York City, said in a statement: "It is commonplace to initiate antibiotic treatment for patients hospitalized with exacerbation of COPD. ... It is reassuring to see that in this study, patients treated with antibiotics did indeed show a better outcome compared to those patients in whom antibiotics were withheld.

The authors acknowledged some limitations of their study, including the possibility of selection bias because of the observational design, the use of administrative data, and the lack of a validated method for identifying patients with acute COPD exacerbations using only administrative data.

For more information:

COPD World News     Week of June 6, 2010

Beta-Blockers May Benefit COPD

Utrecht, Netherlands - Patients with chronic obstructive pulmonary disease (COPD) had about a 30% reduction in deaths and disease exacerbations when treated with beta-blockers, data from a large cohort study showed.

The study reviewed electronic medical records for 2,230 patients with and without coexisting cardiovascular disease (CVD, which frequently develops in COPD patients) and found those taking cardioselective beta-blockers had lower mortality but similar rates of COPD flare-ups compared with patients on nonselective agents, reported Frans H. Rutten, MD, PhD, of the University Medical Center Utrecht in the Netherlands, and colleagues, in the Archives of Internal Medicine. The results fly in the face of the conventional wisdom to avoid beta-blockers in patients with COPD and add to previous evidence suggesting that beta-blockers might also benefit patients with COPD.

"A meta-analysis of randomized trials has already shown that cardioselective beta-blockers are well tolerated by patients with COPD," Rutten and his co-authors concluded. "The time has come to confirm these results in a randomized controlled trial."

COPD, which encompasses emphysema and chronic bronchitis, is expected to become the third leading cause of death in the Western world by 2020, with a majority of those deaths due to co-morbid CVD, according to background information in the article. The association between COPD and cardiovascular disease often complicates differential diagnosis and either condition can go unrecognized or be confused with the other, especially in the elderly (Eur J Heart Fail 2006; 8: 706-11). For example, breathlessness, fatigue, and even chest pain on exertion can be caused by COPD or by heart failure. 

Beta-blockers have well documented effectiveness for treating a number of CVD conditions, including heart failure, hypertension, and ischemic heart disease. However, medical dogma has held that beta-blockers should be avoided in patients with COPD, because of its presumed bronchoconstrictive properties and competitive interference with β2-agonists, the authors noted.  But beta-blockers might benefit COPD patients by minimizing sympathetic nervous system activation or reducing ischemic burden, they continued.  While some studies have suggested that beta-blockers reduced mortality in at least some patients with COPD and CVD, evidence was lacking of benefits for COPD patients without overt CVD.

In an accompanying editorial, Don D. Sin, MD, and S.F. Paul Man, MD, of the University of British Columbia in Vancouver, agreed with the authors that the results require confirmation in a large, randomized controlled trial. However, they suggested physicians can exercise clinical judgment in deciding whether to give beta-blockers to COPD patients who also have CVD conditions for which beta-blocker use is indicated.  "To this end, Rutten and co-authors' study has turned the story of beta-blockers in COPD into a curious case of a foe becoming a potential friend to millions of patients with COPD worldwide," Sin and Man wrote.

For more information:

COPD World News     Week of May 30, 2010

Doctors, Patients Differ on COPD Concerns

New Orleans, LA - Doctors and patients with chronic obstructive pulmonary disease (COPD) agree that shortness of breath is the condition's most debilitating symptom, but on other issues patients and clinicians are not on the same page, a survey reported here shows.  "Patients and physicians are both aware of the prevalence of morning symptoms, but physicians are less aware of the prevalence and importance of symptoms in the afternoon and evening," Ronald Balkissoon, MD, of the University of Colorado Health Sciences Center in Denver, wrote in his poster presentation at the 2010 American Thoracic Society annual meeting.

"Patients worry most about symptoms worsening over time, whereas physicians thought their patients worried most about being put on oxygen," Balkissoon reported. He and his colleagues interviewed 1,187 patients via telephone in April and May of 2009 to get their opinions on various aspects of COPD and its symptoms.  And in May 2009 they surveyed 499 doctors -- 200 pulmonary disease specialists and 299 primary care physicians.

The largest group of patients, about 62%, expressed concern about worsening symptoms.  About 63% of doctors thought that was a major concern as well, although doctors believed other symptoms were more of a problem. Among the significant differences between physicians and patients: 75% of physicians thought that their patients most feared being put on oxygen, but only about 47% of patients considered that their major concern. 

Most of the doctors (73%) thought that losing independence was a major fear of patients, but just 55% of patients expressed that concern.  Only 17% of doctors thought patients were fearful of not seeing friends and family more often, but that concern was mentioned by about 40% of the patients.  Doctors also underestimated that the ability to handle aspects of personal hygiene was feared by patients, an underestimation as 40% of patients said that was a concern. 

Almost half of the doctors (46%) thought that the possibility of having to leave their home would be fearful for patients, but just 36% of the patients agreed.  Only 6% of doctors believed that patients would be fearful about their ability to continue working, whereas 22% of the patients expressed that same concern.

"Increasing physician awareness of the gaps that exist between patients' and physicians' perceptions of the burden of COPD may make counseling efforts more effective," Balkissoon wrote.

For more information:

COPD World News     Week of May 23, 2010

Vitamin E May Reduce COPD Risk

New Orleans, LA - Vitamin E supplementation modestly reduced the risk of new-onset chronic obstructive pulmonary disease (COPD) in a large randomized clinical trial. Participants randomized to vitamin E had a 10% reduction in the hazard for COPD during 10 years of follow-up in the Women's Health Study (WHS). The difference remained after adjustment for smoking, aspirin use, and a variety of other clinical and demographic factors.

Despite the positive outcome, the results should be interpreted cautiously, Anne H. Agler, MSc, said here at the American Thoracic Society meeting. "Further study is required to confirm these findings and determine if vitamin E may be a preventive strategy for chronic lung disease," Agler, of Cornell University in Ithaca, N.Y., said during an ATS press briefing.

"Balancing risks and benefits is important before making recommendations, particularly because vitamin E supplements have been shown to have detrimental effects in some people. For example, patients with cardiovascular disease taking vitamin E supplements have been reported to have an increased risk of congestive heart failure.

" One hypothesis of COPD risk centers on the balance of oxidant and antioxidant forces in lung tissue. Observational studies have consistently demonstrated an association between increased antioxidant status and a reduced risk of COPD.  In contrast, combined supplementation of vitamins E and C and beta-carotene had no effect on the rate of hospitalization for COPD or asthma in the Heart Protection Study.

In an effort to clarify the relationship between antioxidants and chronic lung disease, investigators analyzed data from the WHS, which involved 39,887 female health professionals ages 45 and older, followed for 10 years.

For more information:

COPD World News     Week of May 16, 2010

Tips to Protect Lungs on Elevated Ozone Days

Chapel Hill, NC - It's a harmless-looking pale blue gas, a relative of the oxygen molecule that sustains life. In the upper atmosphere, a layer of it protects us from the sun's harmful rays. But ozone molecules, composed of three oxygen atoms, can trigger breathing problems when they form near the ground, said David Peden, MD, director of the Center for Environmental Medicine, Asthma and Lung Biology at the UNC School of Medicine.

Ozone pollution is more common during "ozone season," which begins in April and peaks in the warm summer months. Ozone forms on hot, sunny days when pollutants from car exhaust, power plants, gas stations and industrial facilities undergo chemical reactions in sunlight. Meanwhile, the stagnant weather systems that often form in summer can trap pollution around a community...research has shown that exposure to ozone inflames the lungs, which can aggravate other breathing problems.

To protect themselves on elevated-ozone days, individuals should avoid outdoor air in the afternoon, when ozone levels peak. "Do most of your vigorous outdoor work in the morning or in the evening, after the ozone has decreased."

More tips for healthy lungs - Check your weather forecast for ozone predictions. In North Carolina, a Code Orange day means the air is unhealthy for sensitive people. A Code Red ozone day indicates that everyone should avoid breathing outdoor air.  If you have access to an indoor gym, exercise there when ozone levels are high. Or try walking inside a mall or other enclosed space.

If you have asthma or COPD, work with your doctor to keep it under control throughout the year so that you have fewer problems during ozone season.  Peden said some studies suggest that eating food rich in antioxidants, such as blueberries, beans and pecans, may reduce the effects of ozone exposure.

It's likely that breathing other pollutants can make ozone exposure worse so one should definetly keep away from cigarette smoke.

For more information:

COPD World News     Week of May 9, 2010

FDA Announces End for CFC-Propelled Inhalers

Washington, DC - The FDA has ordered seven chlorofluorocarbon (CFC)-propelled inhalers for the treatment of asthma and chronic obstructive pulmonary disease removed from the market over the next nine months to meet its obligations under a treaty designed to protect the ozone layer.

The following is a list of the inhalers and their deadlines for removal: Nedocromil (Tilade Inhaler) on Dec. 31, 2010 Metaproterenol (Alupent Inhalation Aerosol) on June 14, 2010 Triamcinolone (Azmacort Inhalation Aerosol) on Dec. 31, 2010 Cromolyn (Intal Inhaler) on Dec. 31, 2010 Flunisolide (Aerobid Inhaler System) on June 30, 2011 Albuterol and ipratropium combination (Combivent Inhalation Aerosol) on Dec. 31, 2013 Pirbuterol (Maxair Autohaler) on Dec. 31, 2013.

 Of the seven, only flunisolide, the albuterol/ipratropium combination, and pirbuterol are still being manufactured. The extended period before the system phaseout will give patients time to discuss alternative treatments with healthcare professionals, the FDA said on its Web site.

The announcement is the result of government obligations made under the Montreal Protocol on Substances that Deplete the Ozone Layer, which put a definitive end date on the manufacture and sale of products that deplete the ozone layer, including the CFCs in asthma inhalers. The FDA warned patients that the availability of the phased-out products is uncertain and that alternatives to current treatments should be discussed with a healthcare professional as soon as possible.

While patients may still use a CFC emitting inhaler for as long as they are sold, a replacement may not be available should the patient run out of medication.  The agency listed alternatives that include inhalers propelled with hydrofluoroalkane, as well as powdered treatments and liquids used with nebulizer machines. The document cautioned that the new treatments may function differently than the phased-out products.

The production of CFC emitting products, including a wide variety of refrigerants and propellants, has been eliminated in the U.S. since Jan. 1, 1996, with the exception of limited products such as MDIs.

For more information:

COPD World News     Week of May 2, 2010

Smoking Ban Linked to Drop in Hospital Admissions

Toronto, ON - Hospital admissions for cardiovascular and respiratory conditions declined by 30% to 40% following implementation of a smoking ban in Toronto-area restaurants, data from a Canadian study showed.

Admission rates for the two types of conditions did not change in two other cities that had no smoking bans, nor did admission rates for other types of medical conditions. Implementation of the smoking ban in other settings did not influence hospital admission rates, according to an article published online in CMAJ.

"Our results serve to expand the list of health outcomes that may be ameliorated by smoking bans," Alisa Naiman, MD, of the University of Toronto, and colleagues wrote in conclusion. "Further research is needed to establish the types of settings in which smoking bans are most effective.  Our results lend legitimacy to efforts to further reduce public exposure to tobacco smoke."

Studies of the health benefits of smoking bans have tended to focus on hospital admissions related to myocardial infarction (MI), rates of which have declined by as much as 40% following implementation of smoking bans, the authors wrote.  Few studies had examined the impact of smoking bans on other cardiovascular outcomes or on respiratory conditions.

To address the lack of informative data, Naiman and colleagues calculated admission rates at Toronto hospitals from January 1996 to March 2006, covering the period from three years before the first phase of a smoking ban went into effect to two years after implementation of the last phase.  Their analysis focused on three cardiovascular conditions (MI, angina, and stroke) and three respiratory conditions (asthma, chronic obstructive pulmonary disease, and pneumonia or bronchitis).

For comparison, the investigators chose Durham Region and Thunder Bay, two Ontario communities that did not have public smoking restrictions until after the final phase of the Toronto ban went into effect.  Additionally, Naiman and co-authors chose three control medical conditions: acute cholecystitis, bowel obstruction, and appendicitis, illnesses not known to be related to smoking.

During the 10-year review period, the crude hospital admission rate for the three cardiovascular conditions combined decreased by 39%.  The ban on smoking in restaurants significantly reduced admissions for each of the three cardiovascular conditions and for each of the three respiratory conditions. The analysis showed no consistent effect of the smoking ban in other settings.

Hospital admission rates for the cardiovascular and respiratory conditions did not change significantly in the two communities that did not have a smoking ban.  Moreover, admission rates for the three control medical conditions did not change significantly during the period reviewed.

The investigators noted that the study was limited in assigning causality to the smoking ban for the decrease in hospital admissions since data were not available on rates of smoking, quitting smoking, number of nonsmokers, exposure to secondhand smoke, etc.  "Legislated bans on smoking are associated with reduced rates of admission to hospital, reinforcing the value of such bans for public health," the authors concluded.

For more information:

COPD World News     Week of April 25, 2010

Oral Vaccine May Help People With COPD

New York, NY - An experimental vaccine for chronic obstructive pulmonary disease (COPD), a progressive respiratory disease that afflicts millions of people, may reduce flare-ups in those with severe forms of the illness, new research finds.

Unlike regular childhood vaccinations or the flu shot, this vaccine, which is made from the bacteria that causes meningitis in children, does not prevent COPD but rather tames the severity, duration and frequency of flare-ups. 

"It's not an ideal study but it is suggestive that using this novel oral vaccine can reduce the number of serious COPD exacerbations," said Dr. Norman H. Edelman, chief medical officer of the American Lung Association. "That's a very significant finding and could be a very, very useful tool in the management of severe COPD."  Dr. Len Horovitz, a pulmonary specialist with Lenox Hill Hospital in New York City, added, "they're modest results but certainly favorable and it would seem to be non-toxic."

Currently available treatments include flu and pneumonia shots to prevent infection, and oxygen and medications to improve quality of life. It's unclear if any of these interventions actually prolong life, Edelman said.  "There's not a lot new under the sun," Horovitz said.

Flare-ups of COPD seem to be caused by the wrong bacteria or the wrong proportion of bacteria in the airways, which results in inflammation. "This [new study] is capitalizing on the theory that the inflammation responses due to colonization of bacteria is different in COPD," Horovitz explained."

The vaccine studied in the new trial, HI-164OV, is made from inactivated Haemophilus influenzae, the bacteria responsible for meningitis in children. The study authors, from Australia, were hoping that this inactivated bacteria would trigger a beneficial change in bacteria colonization. The trial was a small one, involving only 38 people, all with severe COPD. 

The patients were randomly selected to receive either the new HI-164OV oral vaccine or a placebo along with best available treatment. The study showed encouraging results.  Although overall COPD exacerbations only went down by 16 percent, moderate-to-severe exacerbations (those requiring corticosteroids) were reduced by 63 percent. The average length of an exacerbation declined by 37 percent, while antibiotics prescriptions declined 56 percent. And hospitalizations were reduced by 90 percent. 

The findings were published in the April issue of the journal Chest. Many of the study authors reported ties with Hunter Immunology Ltd., an Australian biopharmaceutical company that makes HI-164OV.

For more information:

COPD World News     Week of April 18, 2010

Undiagnosed COPD Common

Toronto, ON - Many people with chronic obstructive pulmonary disease (COPD) aren't aware that they have the condition, researchers said.

In a population of long-term smokers, about one in five was found to have COPD after spirometric testing, according to Roger Goldstein, MBChB, of West Park Healthcare Centre in Toronto, and colleagues.  But, only a third of the patients were aware that they had COPD before the testing. The clinical implication, they wrote, is that screening of at-risk people should be more frequent. The findings imply that such screening can lead to early detection of COPD in high-risk patients in the primary care setting.

The prevalence of COPD has been estimated to be about 10% among people 40 and older, but known risk factors, such as older age and history of smoking, can increase the risk.  To measure the prevalence of COPD, the researchers recruited patients 40 and older with a history of at least 20 pack-years of smoking from three primary care practices in Ontario.  All told, 1,003 patients met inclusion criteria, answered a questionnaire about symptoms, and underwent successful spirometry.

To pin down clinical characteristics that might help primary care doctors pick out patients with COPD, the researchers analyzed medical charts of participants who had spirometric evidence of the disease during the first year of the study.  Those with COPD were matched for sex, age within five years, and recruitment site with three or fewer participants who did not have spirometric evidence of COPD.  All told, the chart analysis included 382 participants -107 with COPD and 275 controls - divided into four groups: those with positive spirometry results and a previously charted diagnosis, those with positive spirometry tests, but no previous diagnosis, those with negative spirometry, but a previous diagnosis, and those for whom both spirometry and chart were negative.

A regression analysis showed that few clinical characteristics distinguished among the groups, the researchers said.  The implication is that doctors should encourage spirometry for patients with risk factors for COPD, they said. The participants were almost exclusively white, the researchers cautioned, which may limit the applicability of the findings to other ethnic groups.

For more information:

COPD World News     Week of April 11, 2010

Entest Biomedical announces bioinformatics model for COPD

La Mesa, CA - Entest BioMedical Inc. announced it is creating a bioinformatics-based program combining advances in molecular knowledge of COPD with computer-powered search tools to integrate existing and newly generated data for this condition.

Bioinformatics is defined as the collection, classification, storage, and analysis of biochemical and biological information using computers especially as applied in molecular genetics and genomics. One of the best known applications of bioinformatics methods is the Human Genome Project.

"While there are many pieces to the puzzle of COPD, the majority of research today is focused on finding new pieces as opposed to making sense of the pieces we already have," said Dr. Feng Lin, Scientific Director of Entest. "We have begun a program based on using various automated algorithms to mine existing data sets and develop hypotheses that can be experimentally tested."

One of the initial tasks of the program is the creation of databases containing all genes associated with various aspects of COPD.  These genes will then categorized based on biological functionality and association with each other.  Once a global perspective of the genes and how their functions inter-relate is achieved, examination can be made as to which existing drugs may act somewhere on the pathway and possibility induce a benefit.

"By assembling everything known in the literature regarding COPD at a molecular level, our scientists will have an overall understanding of this terrible disease," said David Koos. "In addition, the bioinformatics approach will allow Entest to develop new intellectual property, some of which we anticipate will include new uses of existing drugs on the market."

For more information:

COPD World News     Week of April 4, 2010

Blood Vessels Bounce Back Once Smokers Quit

Madison, WI - Blood vessel function rapidly recuperates after smokers kick the habit, leading to a reduced risk of heart disease and heart attack, new research shows. The study included more than 1,500 people taking part in a clinical trial to help them quit smoking.

Before and one year after the participants stopped smoking, doctors used ultrasound to measure the patients' flow-mediated dilation (FMD), a gauge of the health of the brachial artery, the main artery of the upper arm. The ability of the brachial artery to relax is closely related to the ability of the heart arteries to relax, and predicts risk for future heart and blood vessel disease, explained the University of Wisconsin researchers. They compared the FMD readings from patients who successfully quit with those who quit and then resumed smoking.

"Individuals who quit smoking had improved blood vessel function, even though they gained weight, which is a common side effect of smoking cessation," study author Dr. James Stein, an associate professor of medicine at UW School of Medicine and Public Health, said in a university news release. "This confirms that quitting smoking is good for your blood vessels and reduces risk for heart attacks and cardiovascular disease."

FMD improved by as much as 1 percent among patients who had quit smoking for a full year. That's a significant improvement, according to Stein. "It's statistically significant, but more important, it's also clinically relevant," he said. "A 1 percent change in FMD is associated with an approximately 14 percent lower rate of cardiovascular disease events. That means patients who permanently quit smoking are less likely to have a heart attack and heart disease."

The study was presented this week at the American College of Cardiology annual meeting in Atlanta and published simultaneously in the Journal of the American College of Cardiology. Cardiovascular disease is the cause of about one-third of smoking-related premature deaths in the United States.

For more information:

COPD World News     Week of March 28, 2010

Oxygen conservers show spotty performance

Cleveland, OH - Devices that help lung disease patients have oxygen therapy on-the-go may not always perform consistently and may, in some cases, provide users with inadequate oxygen when they are active, a new study suggests. The concern, say researchers, is that patients and doctors may interpret any resulting activity limitations as a sign that the lung disease is worsening, when it could instead be a shortcoming of the oxygen device.

The devices in question, known as oxygen conservers, are used mainly by people with COPD, a group of lung diseases that includes emphysema and chronic bronchitis. Oxygen conservers attach to the portable oxygen cylinders that many COPD patients carry because they need supplemental oxygen as they walk, climb stairs or perform other daily activities. The conservers are designed to dole out a set oxygen dose each time a person inhales; this allows the cylinders' oxygen supply to last longer than it would if the oxygen flow were continuous.

In the new study, researchers at Case Western Reserve University in Cleveland, Ohio, tested four of what they describe as the most widely used oxygen conservers on the market.

Overall, the study found, the conservers' performance varied from product to product. And, none of the devices consistently performed up to technical expectations, according to findings published in the American Journal of Respiratory and Critical Care Medicine.

One conserver was no better than breathing standard room air when it came to maintaining patients' blood oxygen levels during rest or exercise, senior researcher Dr. Edward Regis McFadden, Jr. told Reuters Health.  The other three conservers performed better, he said, but patients' oxygen levels dipped when they walked on a treadmill compared with their levels at rest. In contrast, patients' oxygen levels were maintained when the room was supplied with oxygen.

As a group, the conservers' actual oxygen doses differed from what was expected based on bench testing. Two devices consistently delivered less than the expected amount of oxygen during rest and exercise, according to the researchers.Moreover, they found, the amount of walking each study participant accomplished varied according to which conserver he or she was using.

The problem, according to McFadden, is in the technical aspects of the conservers. The devices, he said, are unable to keep up with a person's breathing, matching each breath with a consistent dose of oxygen. All of the devices in this study showed "suboptimal activation with breathing," the researchers write. 

For more information:

COPD World News     Week of March 21, 2010

Secondhand Smoke Starts Damaging Arteries in Childhood

Turku, Finland - Reseachers here have found that passive exposure to secondhand smoke is tied to blood vessel damage in young children. 

The authors of the new study examined 494 children and found that those exposed to secondhand smoke between the ages of 8 and 13 were more likely to show thickening of blood vessel walls, a precursor to hardening, clogging of arteries.  Kids exposed to secondhand smoke are also more likely to have other risk factors for heart disease, Finnish researchers warn. The researchers also found that the kids who were exposed to the most tobacco smoke had higher levels of apolipoprotein B, which contributes to "bad" cholesterol, another heart disease risk factor.

"Although previous research has found that passive smoke may be harmful for blood vessels among adults, we did not know until this study that these specific effects also happen among children and adolescents," study author Dr. Katariina Kallio, research fellow at the Research Center of Applied and Preventive Cardiovascular Medicine at Finland's University of Turku, said in a news release from the American Heart Association.

"These findings suggest that children should not face exposure to tobacco smoke at all, Kallio said. Even a little exposure to tobacco smoke may be harmful for blood vessels. We need to provide children with a totally smoke-free environment."

According to Kallio, Finnish children are exposed to about the same level of secondhand smoke as U.S. kids.  The findings will be published in an upcoming issue of the journal Circulation: Cardiovascular Quality and Outcomes.

For more information:

COPD World News     Week of March 14, 2010

COPD Patients Respond to Formoterol

New Orleans, LA - Chronic obstructive pulmonary disease (COPD) patients treated with formoterol-containing treatments appear to significantly reverse airflow obstruction, even with severe cases of COPD.

"Reversibility of airflow obstruction was achieved by a majority of patients after formoterol-containing treatment," Donald Tashkin, MD, emeritus professor of medicine at UCLA, said at the annual meeting of the American Academy of Allergy, Asthma & Immunology. Depending upon the criteria used, treatment with formoterol achieved an improved response in 51% to 54% of patients.

"The effect of COPD severity on airway reversibility to formoterol had not been evaluated extensively," Tashkin noted. "We investigated reversibility to formoterol-containing treatment in moderate to very severe COPD patients. 

"Formoterol is a long-acting β2-agonist often prescribed in the treatment of asthma. It is often combined with budesonide, a glucocorticoid steroid.  Investigators pooled results of two randomized clinical trials, taking data from common treatment arms in the double-blind, multicenter studies: a six-month trial that compared formoterol-containing treatment arms with placebo and a trial that examined a year-long treatment regimen in COPD patients over 40.

Some 222 patients received twice-daily budesonide/formoterol pressurized metered-dose inhaler 320/9 μg, while the same number received the same drugs in a lower dose (160/9 μg). Another 128 patients were assigned to a formoterol dry powder inhaler (9 μg), while 133 received placebo.

Airflow obstruction reversibility was assessed 30 minutes after study medication on day of randomization as part of serial spirometry testing based on forced expiratory volume in 1 second (FEV1) improvement thresholds.  Tashkin noted that while more than half the patients improved on the formoterol treatments, patients appeared to do better with the combination product.

For more information:

COPD World News     Week of March 7, 2010

Smoking May Affect TIA Risk

San Antonio, TX - Smoking was associated with transient ischemic attack (TIA) at a younger age than was seen in those who have quit or have never taken a puff, a retrospective study showed.

At a single center, smokers who sought emergency treatment for a TIA were more than a decade younger, on average, than nonsmokers, according to Nandavar Shobha (Shoba), DNB, DM, a fellow at the University of Calgary in Alberta. This suggests "a role for smoking-induced thrombus formation in even modest plaques, as significant vascular stenosis was rarely observed in these patients," she said at a press briefing at the American Stroke Association meeting here in San Antonio.  A similar age effect was not seen among patients with ischemic stroke.

Commenting on the study, Bruce Obviagele, MD, of the University of California Los Angeles, said the reason smoking appears to be related to age at presentation for TIA and not for stroke might have something to do with the clot.  "It's thought that the kind of TIAs that you see in smokers might be different from the kind of TIAs or stroke in people who don't smoke or used to smoke," explained Obviagele, who moderated the press conference at which the results were presented.

The clot itself might be more important than the plaque in smokers, he said.  "That clot is a little bit friable and dissolves very easily," he said. "So that's why there might be more TIAs in young people who smoke than in people who have strokes where it's a persistent event due to occlusion and hard plaque as opposed to that soft clot."

Shobha and her colleagues decided to look at the effects of smoking status because they were seeing many young patients with TIA whose only risk factor was smoking.  From April 2002 to May 2007, 1,047 patients with acute ischemic stroke presented to Foothills Medical Center in Calgary within 24 hours of symptom onset. Overall, 22.3% were smokers, 12.5% had quit at least three months before the event, and 65.2% had never smoked. All patients had a head CT scan and a CT angiogram of the head and neck.

There were no significant differences in disease of the neck or intracranial vessels based on smoking status.  Severity of event did not differ among the three groups. At three months after the stroke or TIA, the rate of TIA was 6.7% for current smokers, 5.1% for ex-smokers, and 1.7% for those who had never smoked.  The differences were not statistically significant.

The rate of stroke at three months was similar in the three groups as well. Hypertension and dyslipidemia were more frequent in ex-smokers than in current smokers and those who had never smoked.

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COPD World News     Week of February 28, 2010

Cigar and Pipe Smoking Hurts Lungs

New York, NY - Pipe and cigar smoking, both of which are on the rise, are linked to health impacts similar to those seen with cigarette smoking, researchers found.  Compared with people who had no smoking history, those who smoked pipes or cigars had increased odds of airflow obstruction.  And, the longer a person smoked pipes or cigars the more likely they were to have reduced performance on lung function tests, R. Graham Barr, MD, DrPH, of Columbia University Medical Center, and colleagues wrote.

"These findings, together with increased cotinine levels in current pipe and cigar smokers, suggest that long-term pipe and cigar smoking may damage the lungs and contribute to the development of COPD," they concluded.   "Physicians should consider pipe and cigar smoking a risk factor for COPD and counsel cessation of pipe and cigar smoking regardless of cigarette smoking history."

Cotinine is a chemical that is made by the body from nicotine.  Although cigarette smoking has decreased substantially since the 1960s, pipe and cigar smoking have increased rapidly in recent years with cigar smoking up by 46.4% from 1993 to 1997 and pipe and cigar tobacco smoking up by 28% and 8%, respectively, from 2002 to 2006, according to the report.  Recent questionnaire-based studies found that smoking pipes and cigars raises risk of hospitalization and death, the researchers wrote.

To investigate the risk of COPD, Barr and colleagues set out to determine if pipe and cigar smoking resulted in biological absorption of tobacco smoke, as assessed by urine cotinine levels, and whether these forms of smoking were linked to decreased lung function and airway obstruction. They analyzed data from the 3,528 men and women -- ages of 48 to 90 -- who participated in the Multi-Ethnic Study of Atherosclerosis. The participants' exposure to pipe and cigar smoking was determined using self-report questionnaires.

Their lung function was assessed using spirometry according to American Thoracic Society guidelines and their urine cotinine levels measured through immunoassay. Among the participants, 9% reported pipe smoking (for a median of 15 pipe-years), 11% reported cigar smoking (median of six cigar-years) and 52% reported smoking cigarettes (median, 18 pack-years).

"Some pipe and cigar smokers say they do not inhale, or inhale less than cigarette smokers," the authors wrote. "The elevated cotinine levels in the current study, however, belie this notion and provide a biological measure of nicotine exposure."

The authors cautioned that the study was limited by its cross-sectional design, which could have yielded different results than a long-term study and been subject to selection bias. They also noted that cigarette smoking could have been a confounding factor, but assured that they had attempted to control for this possibility.

In an accompanying editorial, Michael B. Steinberg, MD, MPH, and Cristine D. Delnevo, PhD, MPH, both of the University of Medicine and Dentistry of New Jersey, wrote that the new study adds further evidence that tobacco smoking is unhealthy, no matter the form.  "The results are especially important because the tobacco industry is challenged by decreasing cigarette sales," Steinberg and Delnevo wrote, "and is actively promoting product substitution and concurrent use as an alternative to complete tobacco cessation."

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COPD World News     Week of February 21, 2010

FDA announces new safety controls for long-acting beta agonists

Washington, DC - The FDA recently called for new safety information to be added to the labels of long-acting beta agonists (LABAs) for the treatment of asthma.  The FDA also said that it is "taking other steps to reduce the overall use" of the products.

These new requirements are based on FDA analyses of clinical trials showing that use of these long-acting medicines is associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults and death in some patients with asthma. The drugs involved include the single agent products Serevent and Foradil and combination medications Advair and Symbicort that also contain inhaled corticosteroids. These medications improve a patient’s ability to breathe freely and reduce the symptoms of asthma by relaxing muscles in the lung’s airways.

The new information to appear on the product label also states that the drugs should only be used long-term in patients who cannot control their asthma with other medications, and should be used for the shortest duration of time possible and then discontinued.
LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations only apply to the use of LABAs in the treatment of asthma.

In addition, the FDA will require drugmakers to conduct additional studies to evaluate the safety of LABAs when used in combination with inhaled corticosteroids. The regulator will seek input on the design of these studies at a public advisory committee meeting scheduled for March 2010.

In December 2008, an FDA advisory panel voted that the risks of Serevent and Foradil outweighed the products' benefits. The panel supported the use of the combination medications Advair and Symbicort, which contain an inhaled corticosteroid.

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COPD World News     Week of February 14, 2010

Young Athletes Resist Lure of Smoking in Movies

Princeton, NJ - Adolescents who participate in team sports are better able to resist the temptation to smoke than nonparticipants, even when they watch movies that portray characters lighting up, a recent study has found. Young people who did not participate in team sports were twice as likely to become smokers than those who did join teams.

While team sports helped counter the influence of watching smoking in movies, the likelihood of youths becoming smokers was proportional to the number of times they saw smoking depicted in movies. Adolescents exposed to the most movie smoking were 63% more likely to become smokers than thosewho watched the fewest smoking scenes.

While team sports helped counter the influence of watching smoking in movies, the likelihood of youths becoming smokers was proportional to the number of times they saw smoking depicted in movies. Adolescents exposed to the most movie smoking were 63% more likely to become smokers than those who watched the fewest smoking scenes.

To further explore the links between smoking initiation, movie smoking exposure, and the protective effects of team sports, Dr. Adachi-Mejia and colleagues analyzed data from school and telephone based surveys that assessed movie smoking exposure and team sports participation in 2,048 youths from September through November of 1999 and again from February 2006 through February 2007.

“We found that greater levels of movie smoking exposure were associated with a greater likelihood of established smoking and that at every level of movie smoking exposure, team sports participation was protective for youth smoking,” the authors wrote. “However, we saw a dose-response relationship of movie smoking exposure for the odds of established smoking only among team sports participants.” The researchers were surprised to find that team sports participants were exposed to smoking in movies just as much as non-athletes were and noted that movie smoking exposure seem to exert a universal influence on the study participants.

“In summary, this study supports the benefits of youth participation in team sports, which appears to protect against established smoking even in the face of movie smoking exposure,” they wrote.

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COPD World News     Week of February 7, 2010

Even third-hand smoke carries carcinogens: study

Washington, DC - Old tobacco smoke does more than simply make a room smell stale - it can leave cancer-causing toxins behind, U.S. researchers here reported.  They found cancer-causing agents called tobacco-specific nitrosamines stick to a variety of surfaces, where they can get into dust or be picked up on the fingers. Children and infants are the most likely to pick them up, the team at Lawrence Berkeley National Laboratory in California reported.

“These findings raise concerns about exposures to the tobacco smoke residue that has been recently dubbed ‘third-hand smoke’,” the researchers wrote in the Proceedings of the National Academy of Sciences, available at .

They suggested a good clean-up could help remove these potentially harmful chemicals and said their findings suggest other airborne toxins may also be found on surfaces.  “TSNAs (tobacco-specific nitrosamines) are among the most broadly acting and potent carcinogens present in unburned tobacco and tobacco smoke,” Berkeley chemist Hugo Destaillats, who worked on the study, said in a statement.  “The burning of tobacco releases nicotine in the form of a vapor that adsorbs strongly onto indoor surfaces, such as walls, floors, carpeting, drapes and furniture. Nicotine can persist on those materials for days, weeks and even months.

”The nicotine combines with another common compound called nitrous acid to form tobacco-specific nitrosamines or TSNAs, Destaillats and colleagues found. Unvented gas appliances are the main source of nitrous acid indoors, and vehicle engines emit it too.

The researchers did laboratory tests with cigarette smoke, and also tested a 45-year-old pickup truck driven by a heavy smoker.  The TSNA compound formed quickly if nitrous acids were around—notably in the truck compartment but also in rooms where cigarette smoke wafted. It would be easy to ingest this new compound, they said, calling it “an unappreciated health hazard.”

“Because of their frequent contact with surfaces and dust, infants and children are particularly at risk,” they wrote.“Nicotine, the addictive substance in tobacco smoke, has until now been considered to be non-toxic in the strictest sense of the term,” Kamlesh Asotra of the University of California’s Tobacco-Related Disease Research Program, which paid for the study, said in a statement.

“What we see in this study is that the reactions of residual nicotine with nitrous acid at surface interfaces are a potential cancer hazard, and theseresults may be just the tip of the iceberg.” James Pankow, who also worked on the study, said it may raise questions about the safety of electronic cigarettes, or “e-cigarettes.” which produce a nicotine vapor but not smoke.

The researchers said regulators who have cracked down on second-hand smoke with smoking bans may decide to consider policies on third-hand smoke.

COPD World News     Week of January 31, 2010

Even Mild Lung Disease Affects the Heart

New York, NY -  Heart and lung function appear to be intimately intertwined, so that even mild cases of chronic lung disease affect the heart's ability to pump blood, a new study finds. "It suggests that a larger subset of heart failure may be due to lung disease," said Dr. R. Graham Barr, an assistant professor of medicine and epidemiology at Columbia University Medical Center and lead author of a report in the Jan. 21 issue of the New England Journal of Medicine.

It's long been known that severe chronic obstructive pulmonary disease (COPD) can have damaging effects on the heart, Barr said. But the new report, which covered 2,816 people in a long-running lung study, shows that "even a mild decrease in lung function affects heart function," he said.

Barr and his colleagues used two imaging techniques, computed tomography (CT) scanning and MRI, to measure both heart and lung structure and function.  "We observed a linear straight-line relationship," Barr said.

The probable cause of the loss of ability to pump blood, he said, is a reduced blood supply to the heart.  COPD is the fourth-leading cause of death in the United States. One form of COPD is emphysema, in which lung tissue is destroyed. Another form is chronic obstructive bronchitis, which causes narrowed airways, a persistent cough and excess mucus production. Lung disease is strongly associated with smoking.

The immediate application of the finding to medical practice would be in diagnosis, Barr said. "Our study was not of possible intervention," he said. "Future studies will show how much treatment of the lung affects the heart and how much treatment of the heart affects the lung.

"Barr has begun such a study, which he said is in an early stage.  "These problems take a long time to develop, and so they take a long time to study," he said. The study is expected to last several years.

Meanwhile, physicians seeing people who report such lung problems as shortness of breath might consider testing their heart function, Barr said.  The report is an offshoot of a large study, supported by the U.S. National Heart, Lung and Blood Institute, that focused on finding early stages of heart, lung and blood diseases.

"What makes it a novel finding is that just a slight degree of lung disease can have an overall impact on cardiovascular health," said James P. Kiley, director of the institute's lung disease division. "What we are seeing here is the ability to bring the two conditions together.

"There is a distinct benefit in looking at the two conditions together, Kiley explained. "Understanding cardiovascular disease might help understand lung disease and vice versa," he said. "We can put more emphasis on the possibility that these two do have a link and that the link needs to be explored further, even in the clinical assessment of a patient."

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COPD World News     Week of January 24, 2010

Caregiving Linked to Stroke Risk

Tampa, FL -
According to William Haley, PhD, of the University of South Florida, in Tampa, and colleagues - the strain of caring for a disabled spouse is associated with an increased risk of stroke.
The risk is greater for men, and especially African-American men. On the other hand, there was no significant association of any level of caregiving stress with the risk of coronary heart disease.

One implication of the study, published by the researchers, is that men looking after disabled partners may need extra support. The issue is important because about 12% of Americans older than 45 report they have what the researchers called "family caregiving responsibilities," they noted. And, high caregiver stress has been found to be a risk factor for depressive symptoms and early mortality.

To see how such stress affects cardiovascular health, the researchers turned to the so-called REGARDS study - Reasons for Geographic and Racial Differences in Stroke. It is a continuing epidemiological look at stroke and coronary heart disease incidence and mortality in a large national sample of adults over age 45.

Of the more than 30,000 participants in the study, the researchers found 767 who lived with and cared for a disabled spouse and had no history of stroke or coronary heart disease. Based on interviews and home visits, the researchers divided the participants into those reporting high, some, or no strain associated with caregiving. They also calculated 10-year stroke and coronary heart disease risk.

In a multivariate regression analysis, high caregiving strain was associated with a 13.62% 10-year risk of stroke for high-strain caregivers, the researchers reported. That was 23% higher than the estimated stroke risk of 11.06% for caregivers reporting no strain.

African-American men with high caregiving stress had an estimated 10-year stroke risk of 26.95%, markedly higher than the risk for any other race or sex group.  Among other groups with high caregiving strain, white men had a 10-year risk of about 15%, while white and African-American women had risks estimated to be between 10% and 12%.

The researchers cautioned that the study is cross-sectional, so it could be that people high in some stroke risk factors may simply find caregiving to be more stressful. Other limitations included the fact that there were only a small number of highly stressed African-American men, which could have exaggerated the effect in this group, and the use of risk scores rather than observed stroke and cardiovascular events.

Interestingly, men overall in the study reported lower stress than women, perhaps because they tend to use more paid help and have more assistance from extended family, the researchers said.

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COPD World News     Week of January 17, 2010

Entest BioMedical files for COPD stem cell treatment

San Diego, CA - Entest BioMedical announced recently the filing of a third patent application relating to the area of chronic obstructive pulmonary disease, a condition that affects more than 5 million patients in the United States, resulting in more than 120,000 deaths per year. The application covers an implantable medical device useful in re-directing the immune system to stop tissue inflammation.

“The importance of the inflammatory process in COPD is exemplified by the use of broad-acting steroids that reduce inflammation. Unfortunately, these drugs do not address the cause of the inflammation, and have a variety of adverse effects” Stated Dr. Stephen Josephs, inventor of the technology.

A recent article “Immunologic aspects of chronic obstructive pulmonary disease” by Cosio et al in the New England Medical Journal suggests that COPD may actually be not just a disease of inflammation but, of active immunological attack. The current technology seeks to induce a process in which immunity towards components of the body is blocked.

“To date Entest has filed two previous patent applications covering use of fat stem cell components in COPD and methods of using photoceuticals to enhance stem cell therapy. The current patent application has a variety of derivative uses outside of COPD including treatment of transplantation rejection, and other disease in which the immune system has gone awry” Stated David Koos, Entest’s CEO.

The essence of the technology is the use of existing implantable devices to deliver chemical/protein signals that specifically stop inflammatory reactions in a manner that is more in tune with biological processes. Instead of us “telling the body” what it should do with a blunt-force approach, as is the standard of care, the current invention uses more natural and slow acting interventions.

Entest BioMedical Inc. is a majority owned subsidiary of Bio-Matrix Scientific Group Inc.  The Company is involved with the development of stem cell therapy treatments for Chronic Obstructive Pulmonary Disease (COPD), immuno-cancer therapies, testing procedures for diabetes, stem cell research applications for diabetes and other illnesses.  The Company also is involved with medical device
development (including stem cell extraction instrumentation).

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COPD World News     Week of January 10, 2010

Living With a Smoker Puts Kids at Risk for Emphysema

New York, NY - Children who are around smokers face a higher risk of early emphysema when they become nonsmoking adults, perhaps because their lungs never totally recovered from secondhand smoke exposure, new research suggests.

Researchers reached their conclusions after conducting CT scans on 1,781 non-smokers from six communities in the United States. About half of them grew up in homes with at least one smoker.

"We were able to detect a difference on CT scans between the lungs of participants who lived with a smoker as a child and those who did not," Gina Lovasi, an assistant professor of epidemiology at Columbia University's Mailman School of Public Health, said in a university news release.

"Some known harmful effects of tobacco smoke are short-term, and this new research suggests that effects of tobacco smoke on the lungs may also persist for decades.

"The researchers didn't find a link between childhood exposure to tobacco smoke and lung function. "However, emphysema may be a more sensitive measure of damage compared with lung function in this relatively healthy cohort," Lovasi noted.

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COPD World News     Week of January 3, 2010

FDA Okays New Indication for COPD Inhaler

Washington, DC - The FDA has expanded the approved indications for inhaled tiotropium bromide (Spiriva HandiHaler) to include reducing exacerbations of chronic obstructive pulmonary disease, in addition to its previous approval for COPD maintenance.

Tiotropium is a bronchodilator that works by antagonizing acetylcholine receptors in airway tissues.  The new indication was based on results of two clinical trials with nearly 8,000 patients combined -- one called UPLIFT and a separate six-month study with patients in a Veterans Affairs setting.

Although the drug failed to meet its primary endpoint in UPLIFT, significantly slowing declines in lung function versus placebo, it did show benefits in reducing exacerbations. These were defined as new onset or increase of symptoms over at least three days and required a change in treatment or hospitalization.

Participants in the UPLIFT trial were permitted to use all nonanticholinergic respiratory medications and were assigned to either tiotropium or placebo. The tiotropium group saw a median 16.7-month delay before the first exacerbation of symptoms.

The drug was also associated with a mean 14% reduction in number of exacerbations, though there was no significant difference between groups in exacerbations leading to hospitalization.

In addition to the new indication, the drug's label now includes some of the UPLIFT study data.In a press release, the two companies that co-market the product, Pfizer and Boehringer Ingelheim, said it was the first steroid-free drug approved for COPD maintenance that is also demonstrated to reduce exacerbations.

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