Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.

Summary

This study is a randomized, double-blind, placebo-controlled, three-period cross-over study in approximately 54 subjects with asthma.

Timeline

Start

2017-09-05

Primary completion

2018-01-17

Completion

2018-01-18

Outcome

Met primary endpoint

registry Indacaterol Maleate vs Placebo; p <0.001; Mean Difference (Final Values) 0.1861 (95% CI 0.1293 to 0.2429); ANOVA NCT03257995 ↗

registry Indacaterol Acetate vs Placebo; p <0.001; Mean Difference (Final Values) 0.1463 (95% CI 0.0898 to 0.2029); ANOVA NCT03257995 ↗

Publications

• Miller D, Vaidya S, Jauernig J, Ethell B, Wagner K, Radhakrishnan R, Tillmann HC. Lung function, pharmacokinetics, and tolerability of inhaled indacaterol maleate and acetate in asthma patients. Respir Res. 2020 Sep 23;21(1):248. doi: 10.1186/s12931-020-01501-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Indacaterol	Other / unclassified	150 ug	Inhaled

Indications