An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma

Phase 2 Completed 115 enrolled Boehringer Ingelheim

RandomizedCrossoverDouble-blindTreatment

Summary

The primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification

Timeline

Start: 2006-08
Primary completion: 2007-11
Completion: —

Outcome

Met primary endpoint

paper Peak FEV₁ was significantly higher with 5 μg (difference, 139 mL; 95% CI, 96-181 mL) and 10 μg PMID 21636120 ↗

paper than with placebo (both P < .0001). PMID 21636120 ↗

Publications

Kerstjens HA, Disse B, Schroder-Babo W, Bantje TA, Gahlemann M, Sigmund R, Engel M, van Noord JA. Tiotropium improves lung function in patients with severe uncontrolled asthma: a randomized controlled trial. J Allergy Clin Immunol. 2011 Aug;128(2):308-14. doi: 10.1016/j.jaci.2011.04.039. Epub 2011 Jun 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tiotropium	Other / unclassified	5 ug	Inhaled
Subject	Tiotropium	Other / unclassified	10 ug	Inhaled