An eight-week, double-blind placebo-con trolled crossover trial was conducted with 105 patients in a multicenter study, to determine the efficacy of cromolyn sodium in the preven tion and adjunctive management of bronchial asthma in children. Statistical analysis disclosed significant differences in favor of cromolyn, with the patients indicating decreased wheezing and related respiratory complaints, decreased frequency and severity of acute exacerbations, lessening in the need for adjunctive medica tions, decreased time lost from school or work, and ability on the part of both patient and physician to distinguish the active from placebo therapy.
A second phase of the study involved a 19-to 33-month open trial conducted with 17 placebo-discriminating children in whom the double-blind investigation had indicated cromo lyn to be an effective agent in controlling their symptoms. All were chronically ill, consistently unresponsive to conventional therapeutic medi caments, and frequently in need of cortico steroid therapy. Six had a continuous, unremit ting steroid-dependent form of the disease; in the remaining 11, the asthma was episodic and remitting, and frequent steroids were required. Physician assessment indicated that 13 of the 17 children had a satisfactory response to cromo lyn. Eight patients who had been on intermittent steroid therapy were able to discontinue this completely, while three of the four who had been on continuous steroids were successfully switched to alternate-day therapy.
Eight of the children had at least a 50 per cent improvement in school attendance. Ability to participate in full activity was seen in two-thirds of the responding children. There was a reduc tion in the need for concomitant medication, particularly bronchodilators and steroids, a less ening in the number of isolated asthmatic at tacks and bouts of wheezing, and an increased bodily vigor and sense of well-being. However, the drug did not appear to be a barrier to infection.
Some of the factors that may play major roles in determining this drug's effectiveness include the site of the airway obstruction, the lumen size at that site, the reactivity of the bronchial tree, the strength of the stimulus applied to the air ways, the aerodynamics of aerosol administration, and patient cooperation.
