Asthma, rhinitis, other respiratory diseasesFluticasone propionate/salmeterol combination provides more effective asthma control than low-dose inhaled corticosteroid plus montelukast☆,☆☆
Section snippets
Patient selection
Male and female patients aged 15 years and older were eligible if they had had asthma for at least 6 months and if they had been taking low-to-moderate doses of an ICS for at least 30 days before screening. This included BDP 252 to 420 μg/d, budesonide 400 μg/d, flunisolide 1000 μg/d, FP 176 to 220 μg/d, or triamcinolone acetonide 600 to 800 μg/d. At the screening visit, all patients were required to have a forced expiratory volume in 1 second (FEV1) between 50% and 80% of the predicted normal
Results
In total, 447 patients (87% of whom were white and 92% of whom had had asthma for ≥ 5 years) were randomly assigned to double-blind treatment: 222 in the FP/Salm Combo group and 225 in the FP + montelukast group. The treatment groups were comparable with respect to age, sex, and pulmonary function at screening and the end of run-in (Table I).
Empty Cell FP/Salm Combo FP + Montelukast No. of patients 222 225 Age (y) Mean (SD) 40.2 (14.4) 43.0 (13.7) Range 15-79
Discussion
This study demonstrated that patients whose symptoms were suboptimally controlled with ICS therapy alone had significantly greater improvement in asthma control and significantly fewer asthma exacerbations when their treatment was switched to FP/Salm Combo through the Diskus inhaler than when montelukast was added to low-dose FP therapy.
No significant differences were observed between treatment groups for wheeze, chest tightness, and overall symptoms. However, the patient-reported symptom
Acknowledgements
We thank Amy Schaberg for her assistance with preparation and editing of this manuscript.
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Supported by a grant from Glaxo Wellcome Inc, Research Triangle Park, NC.
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Reprint requests: Harold S. Nelson, MD, National Jewish Medical and Research Center, 1400 Jackson St, Denver, CO 80206.