Inhaled mometasone furoate reduces oral prednisone requirements while improving respiratory function and health-related quality of life in patients with severe persistent asthma - 04/09/11

Doi : 10.1067/mai.2000.110798

James E. Fish, MD^a, Jill P. Karpel, MD^b, Timothy J. Craig, DO^c, George W. Bensch, MD^d, Michael Noonan, MD^e, D.Robert Webb, MD^f, Bernard Silverman, MD^g, Eric J. Schenkel, MD^h, Anthony R. Rooklin, MDⁱ, Joe W. Ramsdell, MD^j, Robert Nathan, MD^k, Jeffrey G. Leflein, MD^l, Jay Grossman, MD^m, David F. Graft, MDⁿ, Richard G. Gower, MD^o, Stuart M. Garay, MD^p, Evangelo Frigas, MD^q, Arthur C. DeGraff, MD^r, Edwin A. Bronsky, MD^s, David I. Bernstein, MD^t, William Berger, MD^u, Lucy Shneyer, MS^v, Keith B. Nolop, MD^v, Judy E. Harrison, MD^v
Philadelphia, Hershey, Easton, and Chester, Pa, Bronx, Brooklyn, and New York, NY, Stockton, San Diego, and Mission Viejo, Calif, Portland, Ore, Kirkland and Spokane, Wash, Colorado Springs, Colo, Ann Arbor, Mich, Tucson, Ariz, Minneapolis and Rochester, Minn, Hartford, Conn, Salt Lake City, Utah, Cincinnati, Ohio, and Kenilworth, NJ
From ^athe Department of Pulmonary Medicine, Thomas Jefferson Hospital, Philadelphia, Pa; ^bMonterfiore Medical Center, Bronx, NY; ^cthe Department of Medicine, Pennsylvania State University, Hershey Medical Center, Hershey, Pa; ^dAllergy, Immunology & Asthma Medical Group, Inc, Stockton, Calif; ^eprivate practice, Portland, Ore; ^fAllergy and Asthma Associates, Kirkland, Wash; ^gthe Department of Allergy & Immunology, Long Island College Hospital, Brooklyn, NY; ^hValley Clinical Research Center, Easton, Pa; ⁱAsthma & Allergy Associates, Crozer-Chester Medical Center, Chester, Pa; ^jUniversity of California, San Diego Clinical Trials Center, USCD Medical Center, San Diego, Calif; ^kAsthma & Allergy Associate, PC, Colorado Springs, Colo; ^lprivate practice, Ann Arbor, Mich; ^mAllergy Care Consultants, Ltd, Tucson, Ariz; ⁿAsthma and Allergic Diseases Department, Park Nicollet Clinic HealthSystem Minnesota, Minneapolis, Minn; ^oRockwood Clinic, Spokane, Wash; ^pNew York Pulmonary Associates, PC, New York, NY; ^qMayo Clinic, Allergic Diseases & Internal Medicine, Rochester, Minn; ^rHartford Lung Physicians Research Center, Hartford, Conn; ^sIntermountain Clinical Research, Salt Lake City, Utah; ^tBernstein Clinical Research Center, Inc., Cincinnati, Ohio; ^uSouthern California Research Center, Mission Viejo, Calif; ^vSchering-Plough Research Institute, Kenilworth, NJ

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.)

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Keywords : Mometasone furoate, severe persistent asthma, oral corticosteroid–dependent asthma, prednisone, glucocorticoid, health-related quality of life, steroid sparing

Abbreviations : AQLQ, HPA, HRQOL, ICS, MF, OCS, PEF

Plan

Methods

Patients

Protocol design

Efficacy measurements

Plasma MF concentrations

Safety assessments

Statistical analysis

Results

Patient characteristics

Double-blind treatment phase

Open-label phase

Safety assessment

Discussion

	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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Vol 106 - N° 5

P. 852-860 - novembre 2000 Retour au numéro

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Inhaled mometasone furoate reduces oral prednisone requirements while improving respiratory function and health-related quality of life in patients with severe persistent asthma - 04/09/11

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