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

Sponsor
AstraZeneca
Study ID
NCT01365533
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    Roflumilast 500 μg, one tablet once daily, orally
  • Placebo — DRUG
    Placebo, one tablet once daily, orally

Study Details

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.

Key Dates

Start date
Dec 31, 2004
Status verified
Sep 2016
Primary completion
Jul 31, 2005
Completion
Jul 31, 2005

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Roflumilast
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change of percent eosinophils in sputum 24 hours after allergen challenge [ Time Frame: From baseline until end of treatment up to 9 weeks ]

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