Objectives: To compare the efficacies of medium-dose
fluticasone propionate (FP), medium-dose triamcinolone acetonide (TAA),
and combined low-dose FP plus salmeterol (SL).
Randomized, double-blind, triple-dummy, multicenter, 12-week clinical
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.
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, 42μ
g 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, 220μ
g 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.
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.