A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics

Summary

The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared to placebo in pediatric participants with asthma.

Timeline

Start

2014-05

Primary completion

2015-02

Completion

2015-02

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Placebo MDPI QID: 18.71 (Standard Error 3.190) % predicted FEV1/hour NCT02126839 ↗

registry LEAST_SQUARES_MEAN Albuterol MDPI 180 mcg QID: 43.73 (Standard Error 3.200) % predicted FEV1/hour NCT02126839 ↗

registry Placebo MDPI QID vs Albuterol MDPI 180 mcg QID; p <0.0001; Mean Difference (Final Values) 25.02 (95% CI 16.10 to 33.94) NCT02126839 ↗

Publications

• Ratnayake A, Taveras H, Iverson H, Shore P. Pharmacokinetics and pharmacodynamics of albuterol multidose dry powder inhaler and albuterol hydrofluoroalkane in children with asthma. Allergy Asthma Proc. 2016 Sep;37(5):370-5. doi: 10.2500/aap.2016.37.3985. Epub 2016 Aug 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Background	Salbutamol	Unknown	180 ug	Inhaled
Background	Salbutamol	Unknown	—	Inhaled

Indications