Jr. Stradling et al., Efficacy and safety of a novel beclomethasone dipropionate dry powder inhaler (Clickhaler (R)) for the treatment of adult asthma, J ASTHMA, 37(2), 2000, pp. 183-190
A randomized, double-blind, double-dummy protocol was used to compare the s
afety and efficacy of beclomethasone dipropionate (BDP) delivered by a nove
l dry powder inhaler (DPI, Clickhaler(R)) or by a pressurized metered-dose
inhaler (MDI) plus spacer. There was a four-week run-in period, completed b
y 240 adult patients, who received BDP via an MDI. Patients with stable ast
hma were then randomized into a 12-week treatment period and received BDP (
less than or equal to 2 mg/day via DPI or MDI). There were no significant d
ifferences in morning: peak expiratory flow (PEF) (primary endpoint), eveni
ng PEF, overall daytime or nighttime symptom scores, or lung function param
eters (forced expiratory volume in 1 sec, forced vital capacity) between DP
I and MDI. The safety profiles were similar and patient acceptability for C
lickhaler was high. In conclusion, BDP administered via Clickhaler was foun
d to be clinically equivalent to an optimally used MDI. Patients with stabl
e asthma currently receiving BDP via MDI may be effectively switched to tre
atment via Clickhaler DPI.