Comparable bronchodilation with hydrofluoroalkane-134a (HFA) albuterol andchlorofluorocarbons-11/12 (CFC) albuterol in children with asthma

This was an open-label, parallel group, randomized, age-stratified, multice nter study designed to compare the safety and efficacy of regular use of al buterol formulated in hydrofluoroalkane-134a (HFA albuterol) and albuterol formulated in chlorofluorocarbons-11/12 (CFC albuterol) in children with as thma. Children age 4-11 years using a short-acting inhaled beta(2)-agonist for 6 months to manage stable asthma, and with a prestudy forced expiratory volume in 1 sec (FEV1) of >50% predicted after withholding short-acting in haled beta(2)-agonists for at least 6 hr, an increase in FEV1 greater than or equal to 12% within 30 min after two puffs of CFC albuterol, and the cap ability to comply with medication withholding requirements were eligible fo r study entry. After screening evaluation, patients entered a minimum 7-day run-in period. On study day 1 spirometry and a baseline 12-lead electrocar diogram (ECG) were performed, pulse and blood pressure were measured, and p atients serf-administered two puffs of their randomized study drug, either HFA albuterol or CFC albuterol. Serial spirometry was performed over 6 hr a fter study drug dosing. Pulse and blood pressure were measured just prior t o each spirometry and a 12-lead ECG was performed at 60 min postdose. Patie nts took two puffs of their study drug four times a day for 4 weeks. At stu dy week 4, study day 1 procedures were repeated. Patients maintained a dail y diary of morning (A.M.) and evening (P.M.) peak expiratory flow (PEF), da ytime asthma symptom scores, nighttime asthma sleep disturbance scores, and study drug use. Demographics and baseline characteristics of the 63 patien ts randomized to HFA albuterol (33) and CFC albuterol (30) were similar. No significant differences were found between the HFA albuterol and CFC albut erol treatment groups for any of the primary or secondary FEV1 efficacy var iables either at study day 1 or study week 4. No significant differences we re noted between treatment groups for A.M. and P.M. PEF, individual asthma symptom scores, nighttime asthma sleep disturbance scores, and rescue study drug use over the 4-week study. No significant differences were found betw een the two treatment groups for change from predose in heart rate, systoli c and diastolic blood pressure, and 12-lead ECG intervals at either study d ay 1 or study week 4. Adverse event reporting was similar for the two treat ment groups. In this study, with regular use of HFA albuterol in children w ith asthma, there was a similar safety profile and comparable bronchodilato r efficacy as with CFC albuterol.