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Clinical Investigations: ASTHMA |

A Dose-Ranging Study of Fluticasone Propionate Administered Once Daily via Multidose Powder Inhaler to Patients With Moderate Asthma*

Robert A. Nathan, MD, FCCP; James T. C. Li, MD; Albert Finn, MD; Robert Jones, MD; J. Ellen Payne, MS; Jill P. Wolford, RPh; Stuart M. Harding, MD
Author and Funding Information

*From Asthma and Allergy Associates, PC (Dr. Nathan), Colorado Springs, CO; Allergic Diseases and Internal Medicine (Dr. Li), Mayo Clinic and Foundation, Rochester, MN; Allergy and Asthma Centers of Charleston, PA (Dr. Finn), Charleston, SC; Allergy and Asthma Research Group (Dr. Jones), Eugene, OR; Glaxo Wellcome Inc. (Mss. Payne and Wolford, and Dr. Harding), Research Triangle Park, NC.

Correspondence to: Robert A. Nathan, MD, FCCP, Asthma and Allergy Associates, PC, 2709 North Tejon St, Colorado Springs, CO 80907



Chest. 2000;118(2):296-302. doi:10.1378/chest.118.2.296
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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.

Conclusion: Once-daily 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.

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