Efficacy and Safety of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 70 y) (APTA-2217-05).

StatusCompleted
PhasePhase 2/3
Started

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Record History

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  1. Study title revisedv13
  2. Primary completion date: Sep 2006 to Sep 1, 2006
    • Study completion date: Jun 2007 to Jun 1, 2007
    • Start date: May 2004 to May 1, 2004
    v12
  3. Lead sponsor: Takeda to AstraZenecav11
  4. Re-verified, no change to tracked fieldsv10
  5. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Mar 2009 to Jun 2007
    v9
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  1. Study site revisedv8
  2. Primary completion date: Sep 2006
    • Study completion date: Mar 2009
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Study title expanded, about 1 wordv5
  5. 2 versions Re-verified since Apr 18, 2006, no change to tracked fieldsv3-v4
  6. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
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Asthma
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The aim of the study is to investigate the effect of roflumilast (APTA-2217) on lung function in patients with asthma. Roflumilast will be administered orally once daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
Trial Details
NCT Number NCT00242307
Lead Sponsor AstraZeneca
Collaborators: Tanabe Pharma Corporation
Conditions
(from sponsor)		 Bronchial Asthma
Related terms Asthma
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov