Asthma, rhinitis, other respiratory diseases
Inhaled mometasone furoate reduces oral prednisone requirements while improving respiratory function and health-related quality of life in patients with severe persistent asthma,☆☆

https://doi.org/10.1067/mai.2000.110798Get rights and content

Abstract

Background: Inhaled corticosteroid therapy in severe persistent asthma has been shown to reduce or eliminate oral corticosteroid (OCS) use while retaining effective asthma control. Objective: We sought to evaluate the ability of mometasone furoate (MF) delivered by means of dry powder inhaler to reduce daily oral prednisone requirements in OCS-dependent patients with severe persistent asthma. Methods: We performed a 12-week, double-blind, placebocontrolled trial (21 centers, 132 patients) comparing 2 doses of MF (400 and 800 μg administered twice daily) with placebo, followed by a 9-month open-label phase in which 128 patients received treatment with MF. Results: At the endpoint of the double-blind trial, MF 400 and 800 mg twice daily reduced daily OCS requirements by 46.0% and 23.9%, respectively, whereas placebo increased OCS requirements by 164.4% (P < .01). Oral steroids were eliminated in 40%, 37%, and 0% of patients in the MF 400 and 800 mg twice daily and placebo groups, respectively. Pulmonary function and quality of life significantly increased for MF-treated patients. Further reductions in OCS requirements were achieved with long-term MF treatment in the open-label phase. Conclusion: MF inhaled orally as a dry powder is an effective alternative to systemic corticosteroids in patients with severe persistent asthma. (J Allergy Clin Immunol 2000;106:852-60.)

Section snippets

Patients

Male and nonlactating female patients 12 years of age or older with OCS-dependent asthma were recruited from existing patient populations and through advertising at each of 21 medical centers. For eligibility, patients were required to have had severe persistent asthma for at least 12 months before enrollment,20 and they were required to have needed daily or alternate-day OCSs for asthma control for 5 or more of the 6 months before enrollment. Eligible patients were also required to have an FEV1

Patient characteristics

One hundred thirty-two patients were randomized. Demographic and baseline data were similar among groups (Table I).

. Summary of demographics and asthma-related characteristics for all patients

Empty CellPlaceboMF-DPI 400 μg BIDMF-DPI 800 μg BID
Demographics
 No. of patients4346*43
 Sex (M/F)24/1922/2416/27
 White/African American/other37/3/335/8/339/3/1
 Mean age, y (range)55 (26-79)49 (13-83)53 (22-77)
 Body weight, lb (range)184 (132-282)182 (120-275)185 (120-286)
 Never smoked/not in 6 mo23/2029/1730/13

Discussion

We found a clinically significant OCS-sparing effect of MF administered by means of a dry powder inhaler. Compared with patients receiving placebo whose prednisone requirements increased after randomization, those receiving either dose of MF were able to significantly reduce their prednisone requirements, and a substantial proportion discontinued its use altogether. Coincident with prednisone reduction, MF-treated patients experienced significantly better pulmonary function and symptom scores,

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    Supported by Schering-Plough.

    ☆☆

    Reprint requests: James E. Fish, MD, Division of Pulmonary and Critical Care Medicine, Jefferson Medical College, 1025 Walnut St, Room 805, Philadelphia, PA 19107.

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