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Salbutamol dry powder inhaler: Efficacy, tolerability, and acceptability study *
Author(s) -
O'Callaghan Chris,
Everard Mark L.,
Bush Andrew,
Hiller Elizabeth J.,
RossRussell Robert,
O'Keefe Peter,
Weller Peter
Publication year - 2002
Publication title -
pediatric pulmonology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.866
H-Index - 106
eISSN - 1099-0496
pISSN - 8755-6863
DOI - 10.1002/ppul.10048
Subject(s) - medicine , tolerability , dry powder inhaler , salbutamol , inhaler , asthma , anesthesia , adverse effect
Dry powder inhaler (DPI) devices are frequently used in children over 5 years of age in order to avoid coordination difficulties often seen with the use of pressurized metered dose inhalers (pMDI). This study assessed the efficacy, tolerability, and acceptability of salbutamol delivered via two delivery systems, in a population of pediatric patients. The primary aim of the study was to investigate the bronchodilator efficacy of a single dose (100 μg) of salbutamol administered via a dry powder inhaler (Clickhaler®) compared to a similar dose administered by a pressurized metered dose inhaler via a large‐valved holding chamber (VHC) to children with asthma. The study comprised two phases: the first comparator phase, followed by an open 4‐week treatment period. Sixty‐one children with a mean (SD) age of 11.3 years (2.9) (range, 6–17) and mild or moderate asthma completed the study. The primary efficacy endpoint, forced expiratory volume in 1 sec (FEV 1 ), indicated that there was no clinically or statistically significant difference between the bronchodilator effects of salbutamol delivered via either device, with a maximum posttreatment percentage change in FEV 1 (SD) of 12.4% (10.0) and 14.15 (9.3) for Clickhaler® and pMDI plus VHC, respectively. Most patients rated the Clickhaler as easy to use (97%) and liked the device (84%). Both treatments were well‐tolerated. These results support the suitability of salbutamol Clickhaler® as an acceptable, well‐tolerated, and effective alternative to a pMDI plus VHC in mild to moderate asthmatic children over age 6 years. Pediatr Pulmonol. 2002; 33:189–193. © 2002 Wiley‐Liss, Inc.