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document
Comparative efficacy and safety of twice daily fluticasone propionate powder versus placebo in the treatment of moderate asthma . BACKGROUND Fluticasone propionate , an inhaled corticosteroid with negligible systemic bioavailability via the oral route , is efficacious in the treatment of asthma when administered via metered-dose inhaler . OBJECTIVE To evaluate the efficacy and safety of inhaled fluticasone propionate powder in patients with moderate asthma previously treated with an inhaled corticosteroid . METHODS This was a randomized , double-blind , placebo-controlled , parallel-group , multicenter study of 342 adolescent and adult patients with moderate asthma [ forced expiratory volume in 1 second ( FEV1 ) between 50 % and 80 % of predicted ] treated previously by beclomethasone dipropionate or triamcinolone acetonide . Patients received fluticasone propionate powder 50 micrograms , 100 micrograms , 250 micrograms , or placebo via a breath-actuated inhalation device , the Diskhaler , twice daily for 12 weeks . RESULTS Patients in the fluticasone propionate groups experienced a mean increase from baseline to endpoint in FEV1 ranging from 0.43 L to 0.47 L. Patients in the placebo group experienced a mean decrease from baseline of 0.22 L ( P < .001 ) . The probability of patients remaining in the study over time without developing signs of exacerbating asthma was significantly greater in the fluticasone propionate groups than in the placebo group ( P = .001 ) . Asthma symptom scores , supplemental rescue albuterol use , and number of nighttime awakenings due to asthma requiring treatment also improved significantly with all fluticasone propionate treatment regimens compared with placebo ( P < .001 ) . There were no statistically significant differences at endpoint among the three fluticasone propionate groups . No serious drug-related adverse events occurred . CONCLUSIONS Fluticasone propionate powder ( 50 , 100 , and 250 micrograms ) was well-tolerated and significantly improved lung function in patients with moderate asthma .
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Intervention_Pharmacological
fluticasone propionate powder
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Intervention_Control
placebo
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Intervention_Pharmacological
Fluticasone propionate
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Intervention_Pharmacological
inhaled fluticasone propionate powder
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Intervention_Pharmacological
beclomethasone dipropionate
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Intervention_Pharmacological
triamcinolone acetonide
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Intervention_Pharmacological
fluticasone propionate powder
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Intervention_Control
placebo
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Outcome_Other
efficacy and safety
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Outcome_Other
efficacy and safety
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Outcome_Physical
[ forced expiratory volume in 1 second ( FEV1 )
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Outcome_Physical
mean increase from baseline to endpoint in FEV1
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Outcome_Other
remaining in the study over time
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Outcome_Physical
exacerbating asthma
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Outcome_Physical
Asthma symptom scores , supplemental rescue albuterol use , and number of nighttime awakenings due to asthma
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Outcome_Adverse-effects
serious drug-related adverse events
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Outcome_Other
well-tolerated and significantly
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Outcome_Physical
improved lung function
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Participant_Condition
moderate asthma
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Participant_Condition
asthma
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Participant_Condition
moderate asthma previously treated with an inhaled corticosteroid
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Participant_Sample-size
342
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Participant_Age
adolescent and adult
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Participant_Condition
moderate asthma
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Participant_Condition
forced expiratory volume in 1 second ( FEV1 ) between 50 % and 80 % of predicted
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Participant_Condition
moderate asthma