drugset / Trial / NCT01365533
A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma
RandomizedCrossoverDouble-blindTreatment
Summary
The study was a double-blind, placebo-controlled, crossover study to evaluate the efficacy of roflumilast on airway inflammation and function in patients with allergen-induced asthma. Individuals with stable, mild to moderate allergic asthma, with a history of episodic wheeze and shortness of breath, were eligible for enrollment.
Timeline
- Start
- 2004-12
- Primary completion
- 2005-07
- Completion
- 2005-07
Publications
- Bardin P, Kanniess F, Gauvreau G, Bredenbroker D, Rabe KF. Roflumilast for asthma: Efficacy findings in mechanism of action studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S4-10. doi: 10.1016/j.pupt.2015.08.006. Epub 2015 Aug 19.
- Gauvreau GM, Boulet LP, Schmid-Wirlitsch C, Cote J, Duong M, Killian KJ, Milot J, Deschesnes F, Strinich T, Watson RM, Bredenbroker D, O'Byrne PM. Roflumilast attenuates allergen-induced inflammation in mild asthmatic subjects. Respir Res. 2011 Oct 26;12(1):140. doi: 10.1186/1465-9921-12-140.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Roflumilast | Small molecule | 500 ug | Oral |