Journal article
Comparative Efficacy and Safety of Twice Daily Fluticasone Propionate Powder Versus Placebo in the Treatment of Moderate Asthma
Annals of allergy, asthma, & immunology, v 78(4), pp 356-362
01 Apr 1997
PMID: 9109702
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Abstract
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.
To evaluate the efficacy and safety of inhaled fluticasone propionate powder in patients with moderate asthma previously treated with an inhaled corticosteroid.
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 (FEV
1) between 50% and 80% of predicted] treated previously by beclomethasone dipropionate or triamcinolone acetonide. Patients received fluticasone propionate powder 50 μg, 100 μg, 250 μg, or placebo via a breath-actuated inhalation device, the Diskhaler, twice daily for 12 weeks.
Patients in the fluticasone propionate groups experienced a mean increase from baseline to endpoint in FEV
1 ranging from 0.43 L to 0.47 L. Patients in the placebo group experienced a mean decrease from baseline of 0.22 (
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.
Fluticasone propionate powder (50, 100, and 250 μg) was well-tolerated and significantly improved lung function in patients with moderate asthma.
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Details
- Title
- Comparative Efficacy and Safety of Twice Daily Fluticasone Propionate Powder Versus Placebo in the Treatment of Moderate Asthma
- Creators
- David S Pearlman - Colorado Allergy and Asthma Clinic, PC, Aurora, ColoradoMichael J Noonan - Allergy Associates Research CenterDonald P Tashkin - University of California, Los AngelesMarc F Goldstein - Allergic Disease Associates, Philadelphia, PennsylvaniaAbbas G Hamedani - Research Triangle Park FoundationDonald J Kellerman - Research Triangle Park FoundationAmy Schaberg - Research Triangle Park Foundation
- Publication Details
- Annals of allergy, asthma, & immunology, v 78(4), pp 356-362
- Publisher
- Elsevier
- Number of pages
- 7
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pediatrics; General Internal Medicine
- Web of Science ID
- WOS:A1997WU26100005
- Scopus ID
- 2-s2.0-0030953465
- Other Identifier
- 991021931103404721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Allergy
- Immunology