Study shows combination drug therapy for asthma patients is safe

August 31, 2016

A post-marketing safety study mandated by the U.S. Food and Drug Administration has shown that a combination drug therapy for the treatment of asthma is safe and effective.

The therapy tested consisted of a long-acting beta agonist, formoterol, added to an inhaled glucocorticoid, budesonide.

"Our study showed no significant increase in serious adverse events in the combination therapy," said Stephen Peters, M.D., Ph.D., professor of pulmonary, critical care, allergy and immunologic diseases at Wake Forest Baptist Medical Center and lead author of the study.

"A large number of studies have shown that this type of combination therapy really helps and decreases symptoms. Our findings, in combination with results from another FDA-mandated safety study, are very reassuring to those of us who treat asthmatic patients."

The study is published in the Sept. 1 issue of the New England Journal of Medicine.

In this multicenter, double-blind, 26-week study, the scientists evaluated whether the addition of formoterol to budesonide maintenance therapy increased the risk of serious -related events in patients with moderate to . Study participants were age 12 or older, had , received daily asthma medication and had one to four exacerbations in the previous year.

Of the 11,693 patients enrolled in the study, an asthma-related event occurred in 43 patients who received the combination therapy of budesonide and formoterol and in 40 patients who received only budesonide. Two asthma-related deaths were reported in the combination arm of the study and none in the single-therapy group, which is not statistically significant.

In addition, a secondary finding showed a 16.5 percent decrease in in the group as compared to the group receiving budesonide.

Overall, the researchers found that treatment with budesonide-formoterol was associated with a lower risk of asthma exacerbations than budesonide and a similar risk of serious asthma-related events.

Explore further: Single combo inhaler beats standard rx in asthma

Related Stories

Single combo inhaler beats standard rx in asthma

March 5, 2013
(HealthDay)—Maintenance and reliever therapy with a single inhaled corticosteroid plus a rapid-onset, long-acting, β2 agonist (formoterol) seems beneficial for patients with asthma, according to two studies published in ...

Acetaminophen does not aggravate children's asthma

August 17, 2016
Contrary to earlier reports, giving acetaminophen (Tylenol, etc.) for pain and fever does not worsen asthma in young children with the condition, concludes a randomized trial in the August 18 New England Journal of Medicine.

Study compares combination treatments for black adults with asthma

October 27, 2015
Among black adults with asthma treated with an inhaled corticosteroid, adding a long-acting beta-agonist did not improve the time to an asthma exacerbation compared with adding the anticholinergic tiotropium, according to ...

Inhaled steroids may increase risk of nontuberculous mycobacteria lung disease

May 18, 2016
Patients with obstructive lung disease who take inhaled corticosteroids (ICS) may be at greater risk for nontuberculous mycobacteria pulmonary disease (NTM PD), according to new research presented at the ATS 2016 International ...

Certain red flags indicate an increased need for intensive care among patients with asthma

June 29, 2016
In patients admitted to the hospital for asthma, illicit drug use and low socioeconomic status were linked with an increased risk of requiring admission to the intensive care unit. Not adhering to asthma prevention medication ...

Steroid-based treatment may answer needs of pediatric EoE patients

December 19, 2014
A new formulation of oral budesonide suspension, a steroid-based treatment, is safe and effective in treating pediatric patients with eosinophilic esophagitis (EoE), according to a new study in Clinical Gastroenterology and ...

Recommended for you

Exposure to pet and pest allergens during infancy linked to reduced asthma risk

September 19, 2017
Children exposed to high indoor levels of pet or pest allergens during infancy have a lower risk of developing asthma by 7 years of age, new research supported by the National Institutes of Health reveals. The findings, published ...

MicroRNA helps cancer evade immune system

September 18, 2017
The immune system automatically destroys dysfunctional cells such as cancer cells, but cancerous tumors often survive nonetheless. A new study by Salk scientists shows one method by which fast-growing tumors evade anti-tumor ...

'Exciting' discovery on path to develop new type of vaccine to treat global viruses

September 15, 2017
Scientists at the University of Southampton have made a significant discovery in efforts to develop a vaccine against Zika, dengue and Hepatitis C viruses that affect millions of people around the world.

Regular exercise, stress can both make a big difference in lupus, study finds

September 13, 2017
Waking up in the morning with the joint pain, swelling and stiffness that accompanies lupus doesn't exactly inspire a workout.

New research shows asthma drug's effectiveness over usual care alone

September 13, 2017
A new study co-authored by the University of Plymouth and published in The Lancet shows how an asthma drug was more effective at improving a patient's asthma control compared with their usual care.

Study reveals new clues to how a successful HIV vaccine could work

September 12, 2017
Scientists at The Scripps Research Institute (TSRI) have made a discovery that could speed efforts to develop a successful HIV vaccine.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.