Asthma, rhinitis, other respiratory diseases
Fluticasone propionate/salmeterol combination provides more effective asthma control than low-dose inhaled corticosteroid plus montelukast,☆☆

https://doi.org/10.1067/mai.2000.110920Get rights and content

Abstract

Background: Asthma is a disease of chronic inflammation and bronchoconstriction. Inhaled corticosteroids (ICSs) provide important anti-inflammatory treatment but may not provide optimal control of asthma when taken alone. Two therapeutic alternatives for enhanced asthma control are to substitute the combination of fluticasone propionate (FP) and salmeterol (FP/Salm Combo) through the Diskus inhaler or to add montelukast to existing ICS therapy. Objective: We compared the efficacy and safety of FP/Salm Combo through the Diskus inhaler versus montelukast added to FP (FP + montelukast) in patients whose symptoms were suboptimally controlled with ICS therapy. Methods: We performed a multicenter, double-blind, double-dummy, parallel-group, 12-week study in 447 patients with asthma who were symptomatic at baseline while receiving low-dose FP. Patients were treated for 12 weeks with one of the following: (1) combination of FP 100 μg plus salmeterol 50 μg twice daily through the Diskus inhaler, or (2) FP 100 μg twice daily through the Diskus inhaler plus oral montelukast 10 mg once daily. Results: FP/Salm Combo treatment provided better overall asthma control than FP + montelukast with significantly greater improvements in morning peak expiratory flow (+24.9 L/min vs +13.0 L/min, P < .001), evening peak expiratory flow (+18.9 L/min vs +9.6 L/min, P < .001), and forced expiratory volume in 1 second (+0.34 L vs +0.20 L, P < .001), as well as a change in the percentage of days with no albuterol use (+26.3% vs +19.1%, P = .032) and the shortness of breath symptom score (–0.56 vs –0.40, P = .017). The groups had comparable improvements in chest tightness, wheeze, and overall symptom scores. Asthma exacerbation rates were significantly lower (P = .031) in the FP/Salm Combo group (4 patients, 2%) than in the FP + montelukast group (13 patients, 6%). Adverse event profiles were comparable. Conclusion: Symptomatic patients on low-dose ICS therapy had significantly greater improvement in asthma control when switched to the FP/Salm Combo than when montelukast was added to ICS therapy. (J Allergy Clin Immunol 2000;106:1088-95.)

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).

. Demographics and screening/baseline pulmonary function

Empty CellFP/Salm ComboFP + Montelukast
No. of patients222225
Age (y)
 Mean (SD)40.2 (14.4)43.0 (13.7)
 Range15-79

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.

    ☆☆

    Reprint requests: Harold S. Nelson, MD, National Jewish Medical and Research Center, 1400 Jackson St, Denver, CO 80206.

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