Study objective: This dose-ranging study evaluated the
clinical efficacy and safety of inhaled fluticasone propionate
administered once daily via a multidose powder inhaler in patients with
moderate asthma (FEV1, 45 to 75% predicted).
Materials and methods: In this multicenter trial, 330
patients (≥ 12 years old) previously receiving inhaled
corticosteroids or β2-agonists alone were randomized in a
double-blind manner to receive fluticasone propionate at 100, 200, or
500 μg once daily or matching placebo for 12 weeks.
Results: Once-daily treatment with fluticasone propionate
resulted in an improvement in efficacy variables, such as
FEV1, morning and evening peak expiratory flow (PEF),
asthma symptom scores, nighttime awakenings, albuterol use, and
duration of study participation. A dose-related trend was observed for
improvements in morning and evening PEF and albuterol use. Statistical
significance for pairwise comparisons was achieved for 200 μg and 500μ
g fluticasone propionate vs placebo for all efficacy variables, and
for 100 μg fluticasone propionate vs placebo for morning and evening
PEF at most or all time points. Drug-related adverse events were few
(≤ 5%) and mostly related to the topical effects of inhaled
corticosteroids. No dose-response effect or clinically relevant
differences were observed in morning plasma cortisol concentrations or
after cosyntropin stimulation.
treatment with fluticasone propionate was well tolerated and
demonstrated some dose-related trends in improvements in lung function
and asthma control in patients with moderate asthma.