NCT01365533

A Study to Evaluate the Effect of Roflumilast on Airway Inflammation and Function Following Allergen Challenge in Subjects With Allergic Asthma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
DRUG	Roflumilast	Roflumilast 500 μg, one tablet once daily, orally
DRUG	Placebo	Placebo, one tablet once daily, orally

Timeline

• Start date: 2004-12-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2011-06-03
• Last updated: 2016-10-25

Locations

1 site across 1 country: Canada