Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma

Summary

This study is designed to explore lung function effects of two doses of indacaterol acetate, 75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic exposure to indacaterol in plasma with historical data in adults, to identify an appropriate dose to Phase III evaluation.

Timeline

Start

2017-04-18

Primary completion

2019-06-19

Completion

2019-07-17

Publications

• Sekerel BE, Nell H, Laki I, Pak T, Contreras E, Kolarz A, D'Andrea P, Manga V, Jain M, Vaidya S, Valentin M, Sen B. Efficacy, Safety, and Systemic Exposure of Once-Daily Indacaterol Acetate in Pediatric Asthma: A Randomized, Double-Blind, Controlled Dose-Finding Study. Clin Drug Investig. 2023 Sep;43(9):719-728. doi: 10.1007/s40261-023-01300-8. Epub 2023 Sep 8.

Drugs

Indications