AEROSOL BECLOMETHASONE DIPROPIONATE SPRAY COMPARED WITH THEOPHYLLINE AS PRIMARY-TREATMENT FOR CHRONIC MILD-TO-MODERATE ASTHMA

Background: Inhaled corticosteroids and oral theophylline are effectiv e treatments for moderate asthma. Objective: We sought to compare the benefits and adverse reactions of theophylline and aerosol beclomethas one spray. Methods: A multicenter, double-blind, double-placebo, rando mized, controlled trial of 1-year duration was performed. Seven hundre d forty-seven patients with asthma received either beclomethasone dipr opionate aerosol spray (84 mu g four times per day) or sustained-relea se theophylline twice per day in doses adjusted for optimum control of the disease. The main outcome measures were daily diary of symptoms a nd peak flow rates (recorded on a mark-sense computer-readable form); supplemental bronchodilator use; doctor's office or hospital visits an d absence from work or school; spirometry; methacholine testing; adver se experiences; and cortisol blood measurements. Results: Both treatme nt strategies reduced symptoms promptly and achieved low absenteeism f rom work or school and low rates of emergency treatment for asthma. Bo th maintained nearly normal pulmonary function. Beclomethasone was sta tistically significantly more effective in reducing symptoms, suppleme ntal bronchodilator and systemic glucocorticoid doses, bronchial hyper responsiveness, and eosinophilia. However, the magnitude of these diff erences was small. Theophylline caused more headache, nervousness, ins omnia, and gastrointestinal distress, and more patients discontinued t reatment because of side effects. Beclomethasone caused more oropharyn geal candidiases and hoarseness and reduced morning plasma cortisol le vels before and after cosyntropin. It reduced the rate of growth in ch ildren, No new cataracts or glaucoma developed. Conclusion: Theophylli ne effectively controlled symptoms at lower than the customarily recom mended blood level. The risk/benefit profiles of these agents suggest that inhaled corticosteroids may be the preferred agent for most adult patients and for some children.