Chest, Vol 101, 787-792, Copyright © 1992 by American College of Chest Physicians

ARTICLES

Effects of the addition of nedocromil sodium to maintenance bronchodilator therapy in the management of chronic asthma

B Callaghan, NC Teo and L Clancy
Peamount Hospital, Newcastle, County Dublin, Ireland.

STUDY OBJECTIVES: To assess the efficacy and safety of nedocromil sodium metered dose aerosol as an adjunct to sustained-released 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 less than 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 beta 2 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.

This article has been cited by other articles:

				The Childhood Asthma Management Program Research G Long-Term Effects of Budesonide or Nedocromil in Children with Asthma N. Engl. J. Med., October 12, 2000; 343(15): 1054 - 1063. [Abstract] [Full Text] [PDF]

				A M Edwards, J Lyons, E Weinberg, F Weinberg, J D Gillies, G Reid, C F Robertson, P Robinson, M Dalton, P Van Asperen, et al. Early use of inhaled nedocromil sodium in children following an acute episode of asthma Thorax, April 1, 1999; 54(4): 308 - 315. [Abstract] [Full Text]