Controlled trial of two formulations of cromolyn sodium in the treatment of asthmatic patients >= 12 years of age

Study object-res: This multicenter, randomized, double-blind, placebo-contr olled, parallel study compared the efficacy and safety of the hydrofluoroal kane (HFA) formulation of cromolyn sodium metered-dose inhaler (MDI) with t he chlorofluorocarbon (CFC) formulation in asthmatic patients greater than or equal to 12 years old over a 12-week period. Design: Stable asthmatics using only currently marketed cromolyn sodium and as-needed inhaled beta(2)-agonists were randomly assigned to treatment wit h HFA cromolyn sodium, CFC cromolyn sodium, or placebo, administered as two inhalations (2 mg) qid for 12 weeks. Prior to randomization, all patients were required to meet minimum symptom and/or pulmonary function test criter ia after discontinuation of cromolyn sodium. Efficacy was assessed by chang es in daily symptom scores, albuterol use, peak expiratory flow, pulmonary function measurements, and overall opinions of effectiveness. Results: A total of 280 patients in 29 centers were randomly assigned to tr eatment with HFA cromolyn sodium (n = 94), CFC cromolyn sodium (n = 91), or placebo (n = 95), Patients treated with the HFA formulation of cromolyn so dium demonstrated a 28 to 33% improvement over symptom scores (p < 0.05) an d a 35% improvement over placebo in the use of placebo for (p < 0.05), The patients' opinions of overall effectiveness favored HFA cromolyn;n sodium ( p = 0.011) and CFC cromolyn sodium (p = 0.006) over placebo, The investigat ors' opinions indicated a statistically significant difference favoring CFC cromolyn sodium compared with both placebo (p < 0.001) and HFA cromolyn so dium (p = 0.042). No statistically significant differences existed among gr oups in the incidence of treatment-related adverse events. Conclusion: The HFA formulation of cromolyn sodium MDI is a well-tolerated and effective treatment for asthma patients greater than or equal to 12 yea rs old. The safety and efficacy profile of the HFA formulation is comparabl e to that of the CFC formulation.