A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma|
- Change of percent eosinophils in sputum 24 hours after allergen challenge [ Time Frame: From baseline until end of treatment up to 9 weeks ] [ Designated as safety issue: No ]
The primary outcome was the effect of roflumilast on allergen-induced airway eosinophilia.
Two 15 days treatment periods (14 days with treatment and day 15 without treatment) separated by a washout period (approximately 3 to 5 weeks).
- To evaluate the allergen-induced Early asthmatic response (EAR) and Late asthmatic response (LAR) in patients with allergic asthma following repeated dosing of roflumilast [ Time Frame: From baseline until end of treatment up to 9 weeks ] [ Designated as safety issue: No ]
- Allergen-induced EAR as measured by Forced expiratory volume in 1 second (FEV1) within 2 hours after allergen challenge, between roflumilast and placebo (Area under the curve [AUC] and maximal drop)
- Allergen-induced LAR as measured by FEV1 in the period beginning 3 hours and ending 7 hours after allergen challenge, between roflumilast and placebo (AUC and maximal drop)
- To evaluate the effect of roflumilast on allergen-induced Airway hyperreactivity (AHR) [ Time Frame: From baseline until end of treatment up to 9 weeks ] [ Designated as safety issue: No ]Allergen-induced AHR at 24 hours post-allergen, as measured by the Methacholine provocative concentration resulting in a 20 percent reduction in FEV1 (MCh PC20FEV1) and as Doubling concentration factor (DC) required to achieve a decrease in FEV1 of 20 percent, between roflumilast and placebo
|Study Start Date:||December 2004|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
|Active Comparator: Roflumilast||
Roflumilast 500 μg, one tablet once daily, orally
|Placebo Comparator: Placebo||
Placebo, one tablet once daily, orally