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Title: No Added Benefit When Montelukast Added to Fluticasone/Salmeterol in Secondary Asthma Measures: Presented at ATS

"No Added Benefit When Montelukast Added to Fluticasone/Salmeterol in Secondary Asthma Measures: Presented at ATS"

By Marvin Ross TORONTO -- May 23, 2008 -- Patients with both asthma and allergic rhinitis experience significantly better lung function when they are treated with fluticasone propionate/salmeterol powder compared with montelukast sodium, according to research presented here at the 104th International Conference of the American Thoracic Society (ATS). In addition, when fluticasone/salmeterol and montelukast were combined, it did not result in any improvement in asthma symptoms compared with fluticasone/salmeterol alone, according to results of the 4-week, randomised, double-blind, triple-dummy, parallel-group trial. Fluticasone propionate aqueous nasal spray was also superior to montelukast for control of allergic rhinitis. These results were presented on May 18 by Nancy Ostrom, Co-Director, Allergy & Asthma Medical Group and Research Center, San Diego, California, and colleagues. Subjects were aged at least 15 years, had at least a 3-month history of persistent asthma, prior and current use of an asthma therapy with no change in regimen in the month prior to the first visit, a diagnosis of rhinitis with seasonal onset of allergy symptoms during each of the previous 2 relevant allergy seasons, and a positive skin test reaction to a relevant seasonal allergen. Study patients had a forced expiratory volume in 1 second (FEV[₁) between 65% and 95% at the first visit. During the 7 days immediately preceding the second visit, patients experienced at least 3 days when albuterol was required or had a symptom score of at least 2 on at least 3 days using a scale of 0 to 5, and had a diary Daytime Nasal Symptom Score of at least 6 on each of 4 or more days.

Patients were randomised into 4 groups and treated for 4 weeks during a pollen season: (1) fluticasone/salmeterol 100/50 mcg BID plus fluticasone aqueous spray 200 mcg QD; (2) fluticasone/salmeterol 100/50 mcg BID plus montelukast 10 mg QD; (3) fluticasone/salmeterol 100 mcg/50 mcg BID; and (4) montelukast 10 mg QD.

Treatment with fluticasone/salmeterol produced significant improvements in morning peak expiratory flow measures compared with montelukast (P < .01).

No overall additional asthma control was observed when montelukast was added to fluticasone/salmeterol. Secondary asthma measures (FEV₁, symptom-free days, and rescue-free days) were significantly improved with fluticasone/salmeterol compared with montelukast monotherapy (P < .001).

Addition of montelukast to fluticasone/salmeterol produced no benefit in secondary asthma measures. Fluticasone/salmeterol plus fluticasone was superior to fluticasone/salmeterol plus montelukast in improving total nasal symptom scores (P < .001).

No differences were seen in adverse events between the treatment arms and reports of asthma exacerbations were low.

The researchers concluded that asthma control was superior with fluticasone/salmeterol 100/50 mcg BID compared with montelukast 10 mg QD.

In addition, they said that fluticasone/salmeterol was statistically equivalent to fluticasone/salmeterol plus montelukast. Fluticasone/salmeterol plus fluticasone aqueous spray was also superior to fluticasone/salmeterol plus montelukast for seasonal allergic rhinitis, they added.

[Presentation title: In Subjects With Both Asthma and Allergic Rhinitis, Montelukast Added to Fluticasone Propionate/Salmeterol Provides No Additional Clinical Improvements in Overall Asthma Control. Poster E41]

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