ERS: Adding Montelukast to Budesonide as Effective as Doubling Budesonide in Uncontrolled Asthmatics
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ERS: Adding Montelukast to Budesonide as Effective as Doubling Budesonide in Uncontrolled Asthmatics

By Cameron E. Johnston
Special to DG News

STOCKHOLM, SWEDEN -- September 20, 2002 -- People whose asthma is not well-controlled with budesonide alone might do well to add oral montelukast to their inhaled steroid rather than doubling the dose of budesonide. The improvements in lung function are more or less the same with either regimen, but the montelukast/budesonide combination might offer a benefit in terms of convenience with better efficacy as well.

In a presentation at the 12th annual meeting of the European Respiratory Society held here this week, investigators released a sub-analysis from the COMPACT (Clinical Observation of Montelukast as a Partner Agent for Complementary Therapy) study.

This part of the COMPACT study involved 889 adults in 11 countries whose asthma was not well controlled by 400 mcg bid budesonide alone and who had an FEV1 of 50 percent or more of the predicted. As part of the run-in period, patients were allowed to use 400 mcg bid of budesonide (i.e. 800mcg/day) as well as a beta agonist as rescue medication, if needed.

Those who used more than one puff of rescue medication per day were then randomized to use either budesonide 800 mcg/day, along with one 10mg dose of oral montelukast, or 1600 mcg/day of budesonide.

After 12 weeks, both groups showed significant improvements in morning peak expiratory flow of 33.5 and 30.1 LPM respectively. Improvements were also seen in night-time wakenings because of symptoms, use of rescue medications, daytime symptoms and rescue-free days.

In a sub-group analysis, the montelukast/budesonide arm experienced greater changes over baseline compared with the budesonide 1600 mcg arm in terms of men’s and women’s responses, age (both over 45 and under 45), prior steroid use and whether they were "high" or "low" users of rescue beta-agonists.

"Traditionally when patients aren’t controlled on steroids alone, the dose is merely increased," said Dr. Leif Bjermer, of the department of respiratory medicine at the University Hospital of Lund, Sweden. "Now we have data to show montelukast is at least as effective in terms of peak expiratory flow rate as doubling the dose of inhaled corticosteroids, with the additional benefit of faster onset of action."

Dr. Bjermer said that while more studies are needed to determine how well, or for which patients, montelukast should be partnered with budesonide, this study holds out the possibility of allowing patients to use lower doses of steroids, while cutting back to once-a-day use of their puffers.

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