@article {Qaqundah:2016:1088-5412:350,
title = "Albuterol multidose dry powder inhaler and albuterol hydrofluoroalkane versus placebo in children with persistent asthma",
journal = "Allergy and Asthma Proceedings",
parent_itemid = "infobike://ocean/aap",
publishercode ="ocean",
year = "2016",
volume = "37",
number = "5",
publication date ="2016-09-01T00:00:00",
pages = "350-358",
itemtype = "ARTICLE",
issn = "1088-5412",
eissn = "1539-6304",
url = "https://www.ingentaconnect.com/content/ocean/aap/2016/00000037/00000005/art00009",
doi = "doi:10.2500/aap.2016.37.3986",
keyword = "dose response, asthma, hydrofluoroalkane, pediatric, efficacy, children, albuterol, safety, short-acting β2 adrenergic agonist, Dry powder inhaler",
author = "Qaqundah, Paul Y. and Taveras, Herminia and Iverson, Harald and Shore, Paul",
abstract = "
Background:
Many children struggle with albuterol hydrofluoroalkane (HFA) inhalers. Albuterol multidose dry powder inhaler (MDPI) may simplify rescue bronchodilator use in children. 
Objective:
To demonstrate the comparability of albuterol MDPI and albuterol
HFA in children with asthma. 
Methods:
This phase II, multicenter, double-blind, double-dummy, single-dose, five-period, crossover study randomized patients (ages 411 years) with persistent asthma and prestudy forced expiratory volume in 1 second (FEV1)
of 6090% of predicted to 1 of 10 treatment sequences that contained albuterol MDPI (90 and 180 g), albuterol HFA (90 and 180 g), and placebo MDPI and placebo HFA. Efficacy was evaluated by measuring the area under the baseline-adjusted percent-predicted FEV1time
curve over 6 hours (PPFEV1 AUC06) after dosing. Safety was evaluated by adverse events. 
Results:
The full analysis set included 61 patients. Albuterol MDPI and albuterol HFA significantly improved PPFEV1 AUC06
versus placebo (p 0.0107). Mean improvement (\textpm standard error [SE]) in PPFEV1 AUC06 versus placebo with albuterol MDPI at 90 and 180 g was similar (21.2 \textpm 4.87 [95% confidence interval {CI}, 11.6030.81], and 22.6 \textpm 4.87 [95%
CI, 13.0032.20], %\textperiodcenteredhour, respectively). Mean improvement (\textpm SE) with albuterol HFA 180 g was significantly (p = 0.0226) greater versus albuterol HFA 90 g (23.7 \textpm 4.85 [95% CI, 14.1333.23], and 12.5 \textpm 4.85 [95% CI, 2.9322.05], %\textperiodcenteredhour,
respectively). All doses of albuterol were well tolerated. 
Conclusion:
Albuterol MDPI 90 and 180 g and albuterol HFA 180 g provided similar and significant FEV1 improvements versus placebo; albuterol HFA 90 g was significant versus placebo but seemed
less effective based on absolute improvements in FEV1. ClinicalTrials.gov identifier: NCT01899144",
}