EVALUATION OF A NON-CHLOROFLUOROCARBON FORMULATION OF CROMOLYN SODIUM(INTAL) METERED-DOSE INHALER VERSUS THE CHLOROFLUOROCARBON FORMULATION IN THE TREATMENT OF ADULT PATIENTS WITH ASTHMA - A CONTROLLED TRIAL

Background: Cromolyn sodium is a nonsteroidal inhaled antiinflammatory agent for the treatment of asthma, As with other pressurized aerosol medications, the metered-dose inhaler (MDI) formulation currently cont ains chlorofluorocarbon (CFC) propellants, Because of their harmful ef fects on the environment CFCs are now generally banned from production and use, Alternative propellants under production for MDIs include de rivatives of hydrofluoroalkane (HFA). This study uses HFA-227 in an MD I formulation of cromolyn sodium. Objectives: The objectives of the st udy were (1) to examine the efficacy and safety of an HFA formulation of cromolyn sodium (Intal) MDI and (2) to compare the HFA formulation with the CFC formulation. Methods: A multicenter, randomized, double-b lind, placebo-controlled, parallel study with two active groups (HFA-c romolyn sodium [n = 113] and CFC-cromolyn sodium [n = 107]) and a plac ebo-treated group (n = 105). Results: Patients treated with either for mulation of cromolyn sodium MDI showed a statistically significant (p < 0.05) improvement of 12% to 18% compared with placebo in symptom sum mary score, daytime asthma symptoms, and albuterol use. No statistical ly significant differences were observed in pulmonary function. Patien t and physician opinions of overall effectiveness favored HFA-cromolyn sodium over placebo (p = 0.01), with no other significant between-tre atment differences. No statistically significant differences existed a mong groups in the incidence of treatment-related adverse events. Conc lusion: The HFA formulation of cromolyn sodium MDI is a well-tolerated and active alternative treatment for asthma patients aged 12 years an d more.