A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma
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|ClinicalTrials.gov Identifier: NCT01365533|
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : October 25, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Allergic Asthma||Drug: Roflumilast Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2005|
|Active Comparator: Roflumilast||
Roflumilast 500 μg, one tablet once daily, orally
|Placebo Comparator: Placebo||
Placebo, one tablet once daily, orally
- Change of percent eosinophils in sputum 24 hours after allergen challenge [ Time Frame: From baseline until end of treatment up to 9 weeks ]
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 ]
- 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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365533
|Nycomed investigational site|
|Study Director:||AstraZeneca AstraZeneca||AstraZeneca|