EFFECTS OF THE ADDITION OF NEDOCROMIL SODIUM TO MAINTENANCE BRONCHODILATOR THERAPY IN THE MANAGEMENT OF CHRONIC ASTHMA

被引:23
作者
CALLAGHAN, B
TEO, NC
CLANCY, L
机构
[1] Peamount Hospital, Dublin
关键词
D O I
10.1378/chest.101.3.787
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
Study Objectives: To assess the efficacy and safety of nedocromil sodium metered dose aerosol as an adjunct to sustained-release theophylline therapy in adult theophylline-dependent asthma patients and to examine the ability of nedocromil sodium to substitute for theophylline. Design: Randomized double-blind placebo-controlled parallel group study. Two-week baseline, eight-week treatment period. Setting: Out-Patient Clinic. Patients: Sequential sample of 35 adult chronic asthmatic patients maintained on a regimen of sustained-release theophylline (dose range, 400 to 800 mg daily) and on-demand inhaled beta-2-bronchodilators. All patients completed the study. Interventions: 2 x 2-mg nedocromil sodium metered dose aerosol twice daily or matching placebo randomly allocated after two-week baseline. Theophylline dose reduced by half or one third after four weeks of test treatments, then stopped for final two weeks. Use of inhaled beta-2-bronchodilators permitted throughout trial period. Measurements and Results: The following results were in favor (statistically significant findings, p < 0.05) of nedocromil sodium compared with placebo: all diary card efficacy variables (nighttime asthma, morning tightness, daytime asthma, cough, twice daily peak expiratory flow [PEF], inhaled beta-2 use) during all periods of assessment (weeks 1 to 2, 3 to 4, 5 to 6, and 7 to 8) with the exception of cough and nighttime O2 use during weeks 1 to 2; patient and clinician opinion of treatment efficacy (end of weeks 4 and 8); ability to reduce the theophylline dose; clinician assessment of asthma severity at the end of the study, and clinic FEV1 at weeks 4, 5, 6, and 8. One placebo-treated patient reported transient moderately severe nausea and taste loss. No clinically significant changes were seen in the laboratory data. Conclusion: Nedocromil sodium, 4 mg twice daily, conferred significant benefit when added to sustained-release theophylline therapy. The results suggest that nedocromil sodium may permit a reduction in theophylline dosage and possibly substitute for theophylline in previously dependent patients.
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页码:787 / 792
页数:6
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