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Asthma and COPD Studies that Change Lives

ACRC Network Clinical Outcomes

The American Lung Association Airways Clinical Research Centers conduct large clinical trials to provide vital information about caring for people who have asthma and COPD. Since its inception in 1999, the ACRC has made many important contributions to the lives with people with asthma. In 2015 this work expanded to include COPD, impacting positively on the lives of millions of Americans each and every day. Our work is changing the nature of asthma and COPD patient care across the United States.

    Effect of CPAP on Airways Reactivity in Asthma: A Randomized Sham-Controlled Clinical Trial

    • Published by: The Annals of the American Thoracic Society, online July 2016
    • Study: This study from the American Lung Association's Airways Clinical Research Center Network, looked at whether continuous positive airway pressure (CPAP) reduced airways reactivity in asthma. Short-term studies of CPAP in asthma patients had previously shown reductions in airways reactivity in those using CPAP.
    • Results: Adherence to nocturnal CPAP was low and there was no evidence to support positive pressure as effective for reducing airways reactivity in people with well controlled asthma. Regardless, airways reactivity was improved in all groups, which may represent an effect of participating in a study and/or an effect of warm, humid, filtered air on airways reactivity and merits further investigation.
    • The study was co-funded by the American Lung Association (ACRC Network) and the National Heart, Lung, and Blood Institute (NHLBI).

    Effect of a Soy Isoflavone Supplement on Lung Function and Clinical Outcomes in Patients with Poorly Controlled Asthma: A Randomized Clinical Trial

    • Published by: Journal of the American Medical Association (May 26, 2015)

    • Study: This study from the American Lung Association's Airways Clinical Research Centers (ACRC) Networks looked at whether soy isoflavone—a common nutritional supplement—improves the health of people with poor asthma control. During the study, adults and children aged 12 years and older who have poorly controlled asthma took a controller medication. Some study participants also took a soy isoflavone supplement while others took a placebo in place of soy isoflavone.
    • Results: The study found that the soy isoflavone supplement did not improve participants' lung function or clinical outcomes. The results may save consumers from spending thousands of dollars on an ineffective treatment, and also potentially helped some avoid adverse drug reactions.
    The study was co-funded by the American Lung Association (ACRC Network) and the National Heart, Lung, and Blood Institute (NHLBI).

    Treatment of Chronic Sinusitis and Rhinitis with Nasal Steroids Does Not Improve Asthma Control

    • Published by: Journal of Allergy and Clinical Immunology (2014)
    • Study: The network's ninth study, Study of Nasal Steroids in Asthma examined whether long-term treatment of sinonasal disease with mometasone improved asthma control, lung function and quality of life in patients aged 6 years and older with poorly controlled asthma and chronic rhinitis/sinusitis. In previously conducted ACRC trials, researchers have found that more than 70 percent of asthmatics report sinusitis, rhinitis or both.
    • Results: The study found no difference between those taking mometasone versus a placebo in the improvement of their asthma control. Children and adolescents (age 6 to 17 years) experienced no difference in their asthma or sinus symptoms, but those taking mometasone (versus the placebo) did experience a decrease in their lung function. Adult participants who took mometasone showed a small difference in asthma symptoms measured by using the Asthma Symptom Utility Index and in nasal symptoms, but they didn't experience a difference in asthma quality of life, lung function, or episodes of poorly controlled asthma.
    This study was funded by the National Institute of Health's National Heart, Lung and Blood Institute.

    Methacholine Bronchoprovocation - An Unreliable Diagnostic Tool for White and Nonatopic Patients with Asthma

    • Published by: Journal of Allergy and Clinical Immunology (2014)
    • Study: This study evaluated whether methacholine challenge in subjects ages 12 to 70 with stable asthma is a sensitive test to diagnose or confirm asthma. The study also looked at whether using high-potency inhaled corticosteroids (ICS) alters methacholine responsiveness.
    • Results: Results indicated that the methacholine test may not be a reliable tool for conclusively excluding the diagnosis of asthma and that it should not be used as the sole method of diagnosis, especially in white and nonatopic (non allergic)  patients. African-American patients were more sensitive to methacholine challenge than whites (95 percent versus 69 percent, respectively). Additionally, the sensitivity was 82 percent in those with atopy, defined as having one or more positive allergy skin test results, compared with 52 percent in those without. There was no significant difference in the change for high- vs low-dose ICS.

    Heartburn Medication Does Not Improve Asthma in Children who do not Exhibit Symptoms of Acid Reflux

    • Published by: Journal of the American Medical Association (2012)
    • Study: The Study of Acid Reflux in Children with Asthma (SARCA) is similar to the SARA protocol described below, but focused on the connection between asthma and gastroesophageal reflux (GERD), and looked at whether treatments for GERD decreased asthma flare-ups in children.
    • Results: The results of this study found that taking heartburn medication along with asthma treatments did not improve symptoms nor lung function, and were was associated with increased undesirable side effects.
    This study was funded by the National Institute of Health's National Heart, Lung and Blood Institute.

    Heartburn Medication Does Not Improve Asthma in Adults who do not Exhibit Symptoms of Acid Reflux

    • Published by: The New England Journal of Medicine (2009)
    • Study: The Study of Acid Reflux and Asthma (SARA) examined whether there was a connection between asthma and gastroesophageal reflux (GERD). It examined whether treatments for GERD decreased asthma flare-ups in adults. Results: The results of this study found the longstanding practice of prescribing heartburn medication to be ineffective and unnecessarily expensive for some asthma patients who do not exhibit symptoms associated with acid reflux such as heartburn or stomach pain. This finding is considered to be the most comprehensive evaluation to date of how effective (or ineffective) prescription heartburn medication is at controlling respiratory flare-ups in people with asthma whose symptoms have not been well controlled by other therapies. Based on results from both these studies, roughly 1.5 million asthma patients may be taking expensive mediation unnecessarily. For people with asthma currently using a preventative asthma medication, the use of proton pump inhibitors in patients shown to actually have acid reflux instead of all patients with poorly controlled asthma could save over $1.1 billion a year in health care expenditures.
    This study was funded by the National Institute of Health's National Heart, Lung and Blood Institute.

    Noninvasive Questionnaire Can Accurately Screen for Sinonasal Disease

    • Published by: Chest: The Cardiopulmonary and Critical Care Journal (2009)
    • Study: The network's fifth study, Sinusitis and Rhinitis in Asthma was designed to determine whether treatment for sinusitis would improve asthma control.
    • Results: The results of the study identified a simple and reliable five-item questionnaire, based on the frequency of nasal symptoms, to accurately screen for sinonasal disease. The use of this tool is expected to significantly reduce the need for expensive CT scans and invasive endoscopy.

    Placebo Effect Is a True Phenomenon in Assessing Asthma Control in Clinical Trials

    • Published by: Journal of Allergy and Clinical Immunology (2009)
    • Study: The Trial of Asthma Patient Education examined whether patient education and the method of presenting asthma drugs improved the treatment response to both placebo (inactive) and active asthma medications.
    • Results: The results of this study showed that neither the presence of a placebo nor enhancing patients' expectancy about the effectiveness of a drug had an effect on lung function. However, study participants in the placebo-with-enhanced-messages group reported an improvement in their asthma symptoms despite no improvement in lung function. The placebo effect is a well-documented phenomenon among patients; doctors' conversations with study participants can drastically impact a study's results and should be carefully considered.
    This study was funded by the National Institute of Health's National Heart, Lung and Blood Institute.

    Simpler Regimen of a Once-a-Day Drug is Just as Effective as Twice-Daily Treatment for Patients with Mild Persistent Asthma

    • Published by: The New England Journal of Medicine (2007)
    • Study: Leukotriene Modifier or Corticosteroid or Corticosteroid-Salmeterol Trial examined whether treatment for patients with mild asthma that was well controlled with the use of low-dose inhaled corticosteroids twice daily, could be stepped down to an alternative, less intensive treatment strategy—either combination therapy or leukotriene modifier—without a loss of asthma control.
    • Results: The study found that a simpler regimen of a once-a-day combination therapy of inhaled fluticasone plus salmeterol was just as effective as twice-daily treatment of inhaled corticosteroids in patients with mild, persistent asthma. The leukotriene modifier, oral montelukast, while not as effective, did provide good control for most patients. For people with asthma, a simpler treatment plan means fewer drugs to take (and to remember to take) every day and fewer prescription refills. Overall, this reduces medication costs, reduces side effects and makes it easier for people to take their medication as prescribed.  For people with asthma who are at least 6 years old and currently using a preventative medication, the use of once-daily fluticasone plus salmeterol, instead of twice-daily fluticasone could save almost $2 billion per year.

    Low-dose Theophylline, an Inexpensive Asthma Medicine, Improves Asthma Control in Patients not on Inhaled Corticosteroids

    • Published by: American Journal of Respiratory and Critical Care Medicine (2007)
    • Study: Effectiveness of Low Dose Theophylline as Add-On Therapy in Treatment of Asthma examined whether low-dose theophylline could be used safely and effectively as an alternative to the widely used add-on therapy, montelukast. Low-dose theophylline is a relatively inexpensive asthma medicine that has fallen out of favor in recent years because of concerns about its side effects.
    • Results: The study found that low-dose theophylline did not help people improve control of their asthma as an add-on therapy (when asthma is not well controlled, doctors may add on additional therapies to help patients better control their symptoms). However, low-dose theophylline was a useful alternative for people who were not able or willing to take inhaled corticosteroids, an often-used asthma treatment. These results offer immediate clinical data for physicians treating patients who are unable or unwilling to use inhaled corticosteroids. For people with asthma not currently using a preventative asthma medication, the use of theophylline instead of montelukast could save about $800 million a year.<

    The Flu Vaccine Is Safe for People with Asthma

    • Published by: The New England Journal of Medicine (2001)
    • Study: The Study of Inactivated Influenza Vaccine in Asthmatics examined the effect of the influenza vaccination on people with asthma. It was the first large randomized study that examined the effect of the influenza vaccination on people with asthma.
    • Results: The study found that influenza vaccines are safe for both children and adults with asthma. Based on these American Lung Association findings, The Centers for Disease Control and Prevention now recommends flu shots for children with asthma in the Advisory Committee on Immunization Practices of the Centers for Disease Control recommendations and The Healthy People 2020 Goals. Administering the flu vaccine to people with asthma has the potential to majorly reduce hospitalizations and increase cost savings. The Lung Association estimates that if 100 percent of people with asthma were vaccinated, approximately 59,000 adult hospitalizations would be avoided, at a cost savings of close to $569 million. An estimated 45,000 children would avoid hospitalization, saving $182 million.

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