Major Findings with Immediate Clinical Application

Major Findings | Other Completed Trials | Protocols Currently Recruiting 

 List of Centers | Meet the Researchers

Is the Flu Vaccine Safe for People with Asthma?

The network’s first study, known as the Study of Inactivated Influenza Vaccine in Asthmatics (SIIVA) study, found that influenza vaccines are safe for children and adults with asthma. This put to rest previous concerns about possible side effects of the flu shot in people with asthma.  

The study, published in The New England Journal of Medicine in 2001, was the first large randomized study that examined the effect of the influenza vaccination on people with asthma. Based on these American Lung Association findings, the Centers for Disease Control & Prevention (CDC) now recommends flu shots for children with asthma in the Advisory Committee on Immunization Practices of the Centers for Disease Control (ACIP) recommendations and The Healthy People 2020 Goals.

The study findings have the potential to cause a major reduction in hospitalizations and provide substantial cost savings as a result of administering the flu vaccine to people with asthma. The American Lung Association estimates that if 100% of those 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, at a cost savings of $182 million.

Can Inexpensive Asthma Medicine Be Used Safely at Lower Doses?

The network’s second study, Effectiveness of Low Dose Theophylline as Add-On Therapy In Treatment of Asthma (LODO), examined whether low-dose theophylline, a relatively inexpensive asthma medicine that has fallen out of favor in recent years because of concerns about side effects, could be used safely and effectively as an alternative to the widely used add-on therapy, montelukast.

The study, published in the American Journal of Respiratory and Critical Care Medicine in 2007, found that low-dose theophylline did not improve asthma control as an add-on therapy. However, low-dose theophylline was a useful alternative in those patients who were not able or willing to take inhaled corticosteroids, which has become a mainstay of asthma treatment. These results offer immediate clinical data for physicians treating patients who are unable or unwilling to use inhaled corticosteroids. 

Can patients with mild asthma use a less intensive treatment strategy without a loss of asthma control?

The network’s third study, Leukotriene Modifier or Corticosteroid or Corticosteroid-Salmeterol Trial (LOCCS), examined whether therapy could be stepped down in patients with mild asthma that was well controlled with the use of low-dose inhaled corticosteroids twice daily, to an alternative, less intensive treatment strategy without a loss of asthma control.

The study, published in the New England Journal of Medicine in 2007, found that a simpler regimen of a once-a-day inhaler of inhaled fluticasone plus salmeterol was just as effective as twice-daily treatment of inhaled corticosteroids in patients with mild persistent asthma. Oral montelukast, while not as effective, did provide good control for most patients. For patients, a simpler treatment plan means fewer drugs to take—and to remember to take—every day, fewer prescription refills. This can reduce expenditures for medications, and perhaps lead to a reduction in side effects. A more convenient treatment regimen would be expected to result in greater compliance with prescribed medications.

Can patient education improve treatment response?

The network’s fourth study, Trial of Asthma Patient Education (TAPE) which was funded by NIH’s National Heart, Lung, and Blood Institute examined whether patient education and the method of presenting asthma drugs improved the treatment response to both placebo (inactive) and active asthma medications. The results of this study, which were published in the Journal of Allergy and Immunology in 2009, 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.

“This study is significant, because it reveals how the ‘placebo effect’ is affected by doctor-patient communication,” said Norman H. Edelman, MD, American Lung Association Chief Medical Officer. “While the study investigates this well documented phenomenon among patients with poorly controlled asthma, the framework can be replicated to shed light on many other chronic diseases. The bottom line is that positive messages and thoughts are not as effective as proven drug therapies currently available to improve lung function in people with poorly controlled asthma. Clinicians’ conversations with study participants can drastically impact a study’s results and should be carefully considered.”

Can sinusitis treatment improve asthma control?

The network’s fifth study, Sinusitis and Rhinitis in Asthma (SIRNA) was designed to determine whether treatment for sinusitis would improve asthma control. The results of the study, which was published in Chest: The Cardiopulmonary and Critical Care Journal in 2009, 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.  

Can acid reflux treatment help adults with asthma?

The network’s sixth study, Study of Acid Reflux and Asthma (SARA), which was funded by NIH’s National Heart, Lung and Blood Institute, examined whether there was a connection between asthma and gastroesophageal reflux (GERD) and whether treatments for GERD decreased asthma flare-ups in adults. The results of this study, which were published in the New England Journal of Medicine in 2009, 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 the efficacy of prescription heartburn medication to control respiratory flare-ups in asthmatics whose symptoms have not been well controlled by other therapies.

Can acid reflux treatment help children with asthma?

Watch Video

The network’s seventh study, Study of Acid Reflux in Children with Asthma (SARCA), which was funded by which is being funded by NIH’s National Heart, Lung and Blood Institute, is similar to the SARA protocol but focused the connection between asthma and gastroesophageal reflux (GERD) and whether treatments for GERD decreased asthma flare-ups in children. The results of this study, which were published in the Journal of the American Medical Association in 2012, found the addition of heartburn medication to concurrent asthma treatments, did not improve symptoms nor lung function but was associated with increased adverse events.

Is Methacholine Bronchoprovocation challenge still a sensitive test in the diagnosis or confirmation of asthma?

The network’s eighth study, Study of MethaCholine Bronchoprovocation Influence of high potency Inhaled corticoSteroids Core Study (MeClS) evaluated whether methacholine challenge in subjects ages 12 to 70 with stable asthma is a sensitive test in the diagnosis or confirmation of asthma and whether the use of high potency inhaled corticosteroids alters methacholine responsiveness. Results, published in the Journal of Allergy and Clinical Immunology in 2012, indicated that the Methacholine test is an unreliable tool for conclusively excluding the diagnosis of asthma and should not be used as the sole method of diagnosis, especially in white and nonatopic patients. African American patients were more sensitive to methacholine challenge than whites (95% vs. 69%)  In addition, the sensitivity was 82% in those with atopy, defined as having one or more positive allergy skin test results, compared with 52% in those without.