Paper
Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Albuterol (Salbuterol) Multi-dose Dry-Powder Inhaler and ProAir® Hydrofluoroalkane for the Treatment of Persistent Asthma: Results of Two Randomized Double-Blind Studies
Published 2015 · E. Kerwin, H. Taveras, H. Iverson
Clinical Drug Investigation
8
Citations
0
Influential Citations
Abstract
Background and ObjectiveMetered-dose inhalers require patients to coordinate inhalation with actuation. The present albuterol multi-dose dry-powder inhaler (mDPI) does not require patients to coordinate inspiration with actuation, thereby simplifying delivery of albuterol to the lungs. The aim of the present study was to compare the efficacy, pharmacokinetics, pharmacodynamics, extrapulmonary pharmacodynamics, and safety of albuterol (salbuterol) delivered via a ProAir® hydrofluoroalkane (HFA) metered-dose inhaler and an mDPI.MethodsTwo double-blind, randomized, double-dummy, crossover, multicenter, placebo-controlled studies in persistent asthma patients were conducted. Study 1: 47 adult patients were treated with cumulative doses of albuterol mDPI or ProAir HFA (90 µg/inhalation; 1 + 1 + 2 + 4 + 8 inhalations) or placebo. Study 2: 71 patients aged ≥12 years were randomly assigned to receive 90 or 180 μg of albuterol mDPI or ProAir HFA, or placebo. Primary efficacy endpoints were baseline-adjusted forced expiratory volume in 1 s (FEV_1) at 30 min (30-min FEV_1) after each cumulative dose (Study 1) and FEV_1 area under the effect curve over 6 h (FEV_1 AUEC_0–6) after dosing (Study 2).ResultsStudy 1: differences, with corresponding 90 % confidence intervals, between albuterol mDPI and ProAir HFA in FEV_1 after each cumulative dose and in FEV_1 AUEC_0–6 after the final dose were within pre-established equivalence limits. The difference in FEV_1 at high vs. low doses was significant for both active treatments (p < 0.0001). Active treatments were similar in systemic exposure, extrapulmonary pharmacodynamics, and safety. Study 2: mean FEV_1 AUEC_0–6 was significantly greater than for placebo for both doses of albuterol mDPI and ProAir HFA (p < 0.0001). Albuterol mDPI was comparable to ProAir HFA at 90 and 180 µg. Both study treatments were generally well tolerated.ConclusionThe bronchodilatory efficacy and pharmacokinetic/pharmacodynamic profiles of albuterol mDPI and ProAir HFA are comparable, with a safety profile consistent with that of inhaled albuterol.
RCT
Rigorous JournalAlbuterol multi-dose dry-powder inhaler and ProAir HFA are comparable in bronchodilatory efficacy and pharmacokinetic/pharmacodynamic profiles, with a safety profile consistent with inhaled albuterol.
Full text analysis coming soon...