Fluticasone propionate powder: Oral corticosteroid–sparing effect and improved lung function and quality of life in patients with severe chronic asthma,☆☆,

Presented in part at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology, February 1997, in San Francisco, California.
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Abstract

Background: Many patients with severe asthma are dependent on oral corticosteroids for maintenance control of their disease. Treatments that allow patients to be weaned off oral corticosteroids may help to minimize the risk of side effects associated with their chronic use. Objective : This study evaluated whether inhaled fluticasone propionate powder could maintain pulmonary function while reducing the dose of oral prednisone in patients with chronic, severe asthma. Methods : Oral prednisone–dependent (5 to 40 mg/day) adolescents and adults with asthma (n = 111; mean FEV1 = 61% of predicted value) were randomized to placebo or twice daily fluticasone propionate 500 or 1000 μg administered by means of a multidose powder inhaler for 16 weeks in a double-blind, parallel-group study. Patients underwent controlled prednisone reduction on the basis of predetermined asthma stability criteria. Results : Oral prednisone was eliminated by 75% and 89% of patients in the twice daily 500 and 1000 μg fluticasone propionate groups, respectively, versus 9% of the placebo group (P < .001). FEV1 , morning and evening peak expiratory flow, asthma symptoms, albuterol use, and nighttime awakenings improved with fluticasone propionate treatment, achieving statistical significance (P ≤ .009) primarily in the 1000 μg twice daily group. Hypothalamic-pituitary-adrenal axis suppression observed at baseline improved when patients were weaned off oral prednisone to fluticasone propionate. Adverse events ascribed to drug treatment were primarily topical effects of inhaled corticosteroids or those associated with prednisone withdrawal. Patient quality of life assessed by means of the Asthma Quality of Life Questionnaire was clinically and significantly improved after fluticasone propionate treatment (P ≤ .003). Conclusion : Fluticasone propionate powder (500 or 1000 μg twice daily) effectively improved lung function, adrenal function, and asthma-specific quality of life in patients with severe chronic asthma previously treated with oral prednisone while allowing most patients to be weaned off oral corticosteroid therapy. (J Allergy Clin Immunol 1999;103:267-75.)

Section snippets

Patients

Male and female patients 12 years of age or older with chronic asthma diagnosed according to the American Thoracic Society criteria,19 who required regular maintenance treatment with oral corticosteroids over the preceding 6 months, were enrolled provided they had been receiving a stable minimum effective dose of oral prednisone of 5 to 40 mg daily or 10 to 80 mg every other day for at least 2 weeks immediately before the study. Prior use of β2 -agonists was required, whereas prior use of

RESULTS

Demography and pulmonary function of the 111 patients (ages 12 to 77 years) randomized to study treatment were comparable across treatment groups (Table I).

. Demographics, pulmonary function, and disposition of patients at baseline*

Empty CellPlaceboFP 500 μg BIDFP 1000 μg BID
No of patients enrolled344136
Sex, M/F (%)38/6239/6142/58
Age, mean (range) (y)49 (16-74)49 (12-77)50 (15-76)
No of patients receiving daily prednisone273426
No of patients receiving alternate-day prednisone7710
Mean prednisone dose (mg)

DISCUSSION

Despite treatment with inhaled corticosteroids, salmeterol, and theophylline, a proportion of patients with asthma require chronic oral corticosteroids to control their disease. In this trial, patients treated twice daily with fluticasone propionate powder 500 or 1000 μg were able to reduce or eliminate oral prednisone use, as well as discontinue other inhaled corticosteroids, while significantly improving their pulmonary function, asthma control, and quality of life. These results suggest that

Acknowledgements

We thank the following for their contributions to this study: P. Chervinsky, MD, North Dartmouth, Mass; P. E. Korenblat, MD, St Louis, Mo; C. LaForce, MD, Raleigh, NC; D. Q. Mitchell, MD, Jackson, Miss; J. Pinnas, MD, Tucson, Ariz; M. Strek, MD, Chicago, Ill; and S. F. Weinstein, MD, Huntington Beach, Calif. We would also like to thank Shehnaz Gangjee for assistance in writing this manuscript.

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    Supported by a grant from Glaxo Wellcome Inc, Research Triangle Park, NC.

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    Reprint requests: Harold S. Nelson, MD, National Jewish Medical and Research Center, 1400 Jackson St, Room A107, Denver, CO 80206.

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