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Clinical Trial
. 2003 Oct 18;327(7420):891.
doi: 10.1136/bmj.327.7420.891.

Montelukast and fluticasone compared with salmeterol and fluticasone in protecting against asthma exacerbation in adults: one year, double blind, randomised, comparative trial

Leif Bjermer  1 , Hans Bisgaard, Jean Bousquet, Leonardo M Fabbri, Andrew P Greening, Tari Haahtela, Stephen T Holgate, Cesar Picado, Joris Menten, S Balachandra Dass, Jonathan A Leff, Peter G Polos
Affiliations
Clinical Trial

Montelukast and fluticasone compared with salmeterol and fluticasone in protecting against asthma exacerbation in adults: one year, double blind, randomised, comparative trial

Leif Bjermer et al. BMJ. .

Abstract

Objectives: To assess the effect of montelukast versus salmeterol added to inhaled fluticasone propionate on asthma exacerbation in patients whose symptoms are inadequately controlled with fluticasone alone. Design and setting A 52 week, two period, double blind, multicentre trial during which patients whose symptoms remained uncontrolled by inhaled corticosteroids were randomised to add montelukast or salmeterol.

Participants: Patients (15-72 years; n = 1490) had a clinical history of chronic asthma for > or = 1 year, a baseline forced expiratory volume in one second (FEV1) value 50-90% predicted, and a beta agonist improvement of > or = 12% in FEV1.

Main outcome measures: The primary end point was the percentage of patients with at least one asthma exacerbation.

Results: 20.1% of the patients in the group receiving montelukast and fluticasone had an asthma exacerbation compared with 19.1% in the group receiving salmeterol and fluticasone; the difference was 1% (95% confidence interval -3.1% to 5.0%). With a risk ratio (montelukast-fluticasone/salmeterol-fluticasone) of 1.05 (0.86 to 1.29), treatment with montelukast and fluticasone was shown to be non-inferior to treatment with salmeterol and fluticasone. Salmeterol and fluticasone significantly increased FEV1 before a beta agonist was used and morning peak expiratory flow compared with montelukast and fluticasone (P < or = 0.001), whereas FEV1 after a beta agonist was used and improvements in asthma specific quality of life and nocturnal awakenings were similar between the groups. Montelukast and fluticasone significantly (P = 0.011) reduced peripheral blood eosinophil counts compared with salmeterol and fluticasone. Both treatments were generally well tolerated.

Conclusion: The addition of montelukast in patients whose symptoms remain uncontrolled by inhaled fluticasone could provide equivalent clinical control to salmeterol.

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Figures

Fig 1
Fig 1
Cumulative percentage of patients with asthma exacerbations (P=0.599 by log rank test)
Fig 2
Fig 2
Change from baseline in peripheral blood eosinophil counts (103/μl) averaged over the 48 week treatment period (P=0.011 for difference between groups). Mean baseline (during prerandomisation, run-in period) levels of eosinophil counts were 0.34×103/μl in the montelukast-fluticasone group and 0.31×103/μl in the salmeterol-fluticasone group
See this image and copyright information in PMC

References

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