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Fluticasone Alone or in Combination With Salmeterol vs Triamcinolone in Asthma^*

^* From the Georgetown University Medical Center (Dr. Baraniuk), Washington, DC; Allergy and Asthma Research Center (Dr. Murray), Vanderbilt Medical Center, Nashville, TN; Asthma and Allergy Associates, PC (Dr. Nathan), Pueblo, CO; Southern California Research Center (Dr. Berger), Mission Viejo, CA; and Glaxo Wellcome Inc (Mr. Johnson and Drs. Edwards, Srebro, and Rickard), Research Triangle Park, NC.

Correspondence to: James Baraniuk, MD, Georgetown University Medical Center, Division of Rheumatology, Immunology, and Allergy, GL-020 Gorman Building, 3800 Reservoir Rd, Washington, DC 20007-2197; e-mail: BARANIUJ{at}gunet.georgetown.edu

Objectives: To compare the efficacies of medium-dose fluticasone propionate (FP), medium-dose triamcinolone acetonide (TAA), and combined low-dose FP plus salmeterol (SL).

Design: Randomized, double-blind, triple-dummy, multicenter, 12-week clinical trial.

Setting: Allergy/respiratory care clinics.

Patients: Six hundred eighty patients with asthma previously uncontrolled with low-dose inhaled corticosteroids.

Interventions: FP, 220 µg bid; TAA, 600 µg bid; or FP, 88 µg plus SL, 42 µg bid.

Measurements and results: Outcome measures included FEV₁, peak expiratory flow (PEF), supplemental albuterol use, nighttime awakenings, asthma symptoms, and physician global assessment. Compared with TAA, 600 µg bid, treatment with FP 220, µg bid, significantly increased FEV₁, morning and evening PEF, and percent symptom-free days, and significantly reduced rescue albuterol use, number of nighttime awakenings, and overall asthma symptom scores (p 0.035). Improvements with low-dose FP, 88 µg, plus SL, 42 µg bid, were significantly (p 0.004) greater than TAA, 600 µg bid, in all the aforementioned efficacy measures as well as percent of rescue-free days. Combined low-dose FP, 88 µg, plus SL, 42 µg bid, also significantly increased FEV₁ and percent of rescue-free days, and significantly reduced albuterol use compared with medium-dose FP, 220 µg bid (p 0.018). At endpoint, both FP, 220 µg bid, and FP, 88 µg, plus SL, 42 µg bid, significantly increased FEV₁ by 0.48 L and 0.58 L, respectively, compared with 0.34 L with TAA, 600 µg bid.

Conclusion: In patients who are symptomatic while taking low-dose inhaled corticosteroids, medium-dose FP (440 µg/d) and combination treatment with low-dose FP (176 µg/d) plus SL (84 µg/d) are both more effective than medium-dose TAA (1200 µg/d) in improving pulmonary function and asthma symptom control.

Key Words: adrenergic ß-agonists • anti-inflammatory agents • asthma • fluticasone propionate • salmeterol • steroidal • triamcinolone acetonide

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