Inhaled beclomethasone dipropionate has been an effective long-term asthma treatment for more than 40 years. Traditional delivery is by pressurized metered-dose inhaler using a chlorofluorocarbon propellant. Beclomethasone dipropionate recently has been reformulated into a solution, rather than a suspension, with hydrofluoroalkane-134a used as the propellant. Consequently, the corticosteroid can be delivered as an extra-fine aerosol with much smaller particle size that allows better delivery of the medication into the smaller airways. The new formulation also reduces systemic absorption of beclomethasone dipropionate, thereby lessening the risk of systemic adverse effects, such as short-term growth retardation, adrenal suppression, and bone loss or decreased bone mineral density. Nayak and associates studied the safety and efficacy of the new delivery system for inhaled beclomethasone dipropionate in children with moderate asthma. They also evaluated the effectiveness of a lower dosage of extra-fine beclomethasone dipropionate in controlling asthma.
The trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-group hospital outpatient study of children with asthma. Children five to 12 years of age with stable, moderate, symptomatic asthma were screened for inclusion in the study. All of the children were receiving a short-acting beta agonist as needed. A total of 353 children were randomized to receive extra-fine aerosolized beclomethasone dipropionate in a dosage of 40 or 80 mcg twice daily, or placebo. The trial lasted 12 weeks, with assessment of lung function, adverse events, and diary cards every two weeks.
Compared with the placebo group, both treatment groups had a significant, dosage-dependent improvement in lung function as measured by forced expiratory volume at one second (FEV1). There was also a significant decrease in daily beta-agonist use, an improvement in peak expiratory flow, and an increase in the percentage of symptom-free days. The number and type of adverse events were similar among the three groups, and there was no significant difference in morning cortisol levels among the groups at the end of the trial.
The authors conclude that extra-fine aerosolized beclomethasone dipropionate in a dosage of 80 to 160 mcg per day is a safe and effective treatment option for moderate asthma in children. They add that improved lung deposition of the medication allows the use of lower dosages compared with those required for chlorofluorocarbon–beclomethasone dipropionate, and that use of lower dosages may reduce the potential for systemic adverse events.