Nedocromil sodium versus theophylline in the treatment of reversible obstructive airway disease

Abstract

Background: Previous clinical therapeutic research has shown that inhaled nedocromil sodium can replace maintenance oral sustained release theophylline in the management of asthma patients.

Objective: To compare directly the efficacy and safety of nedocromil sodium and sustained release theophylline.

Methods: Using a randomized, double-blind, double-dummy, parallel-group design, 105 patients with reversible obstructive airways disease (77 asthmatic patients) recruited from four referred-care clinics received, in addition to their existing therapy, 4 mg nedocromil sodium four times daily or sustained release theophylline (maximum daily dose 13 mg/kg) for 6 weeks. Patients with serum theophylline levels within the therapeutic range of 10 to 20 micrograms/mL were retained for efficacy analysis. All were included in a tolerability analysis. Day and nighttime symptoms, inhaled bronchodilator use, morning tightness, cough, and twice daily peak flows were recorded on diary cards. Disease severity, lung function and unusual events were evaluated bi-weekly, and opinion of treatment after 6 weeks.

Results: Both treatments improved symptoms, inhaled bronchodilator use and lung function to the same extent. Both treatments were very to moderately effective in > 70% patients. The occurrence of gastrointestinal (P < .05) and central nervous system (P < .01) unusual events was significantly lower for nedocromil sodium compared with theophylline treated patients.

Conclusions: Nedocromil sodium and theophylline were equally effective in this group of patients but nedocromil sodium treatment was associated with significantly fewer side effects, and therefore may be the treatment of choice.