Evaluation of the addition of cromolyn sodium to bronchodilator maintenance therapy in the long-term management of asthma.

Three hundred ninety-seven patients, aged 5 to 63 years, took part in a year-long international multicenter, double-blind, placebo-controlled trial. The patients, whose asthma was considered not adequately controlled, were divided into two groups according to their principal medication at entry (group A, oral and/or inhaled beta 2-bronchodilators; group B, methylxanthines, with or without beta 2-agonists) and randomly allocated to additional treatment with cromolyn sodium (metered-dose inhaler, 2 mg, four times a day, or capsules, 20 mg, four times a day) or matching placebo. A 2-month baseline preceded 10 to 12 months of treatment. After 4 to 8 weeks of treatment, patients were encouraged to reduce bronchodilator usage. Patients used diary cards to record asthma severity, sleep difficulty, morning and evening peak expiratory flow rates, days of disruption of normal activity, use of test treatments, and concomitant medication. Significant differences favoring cromolyn sodium (p less than 0.05 and better) were observed for most of the treatment period in respect to (1) asthma severity, (2) morning and evening peak expiratory flow rates, and (3) days of disruption of normal activity. Patients receiving cromolyn sodium experienced fewer exacerbations and tended to use less concomitant medication than patients receiving placebo. Patients' opinions of treatment significantly favored cromolyn sodium. These results demonstrate the value of the addition of cromolyn sodium to existing therapy in the long-term management of asthma and endorse its use as a first-line treatment.