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PATIENT SELECTION Boys and premenarchal girls aged 4 to 11 years were enrolled if they had asthma6 requiring physician-prescribed chronic pharmacotherapy for at least 6 months and had no other significant pulmonary disease or serious chronic disease. Patients were required to have a baseline peak expiratory flow PEF ; or forced expiratory volume in 1 second FEV1 ; of 50% to 80% of predicted values. Predicted FEV1 and PEF values were based on standards of Polgar and Promadhat7 for sex and height, with standard corrections for African American patients.8 At least 15% reversibility of diminished lung function was required. Patients were excluded from the study if they had lifethreatening asthma. To evaluate the effect of Gentolin HFA on cardiovascular end points, including data collected from Holter monitors, patients were not allowed to take medications with a potential impact on these analyses eg, methylphenidate hydrochloride [Ritalin Hydrochloride] ; . STUDY DESIGN This randomized, double-blind, parallel-group, placebocontrolled study study No. SALA3006 ; was conducted at 11 clinical sites in the United States and Puerto Rico. Institutional review board approval and a written informed consent form for each patient signed by a parent or legal guardian were obtained before the start of the study. The study consisted of a 1- to 2-week run-in period and a 2-week treatment period. At the beginning of the run-in, patients stopped all short-acting 2 -agonist therapy except as-needed albuterol CFC-containing formulation of Ventolinn Inhalation Aerosol, 90 g per puff, 2 puffs ; . Patients also stopped taking long-acting 2-agonists, all forms of theophylline, and ipratropium bromide; patients taking oral corticosteroids during the previous month were not enrolled. Patients were allowed to continue inhaled corticosteroid or cromolyn sodium therapy during the study and to use antihistamines and decongestants as needed, although these medications were withheld before each clinic visit. Patients showing signs of unstable asthma, defined as using 12 or more puffs of rescue albuterol on more than 2 days during the 7 preceding days, were not randomized. The population was stratified by age 4-8 and 9-11 years ; . After the run-in, eligible patients were assigned randomly to 1 of the following 3 treatments administered via MDI every 4 to 6 hours for 2 weeks: 2 puffs of Ventolin.
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