Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)

Sponsor
AstraZeneca
Study ID
NCT00242320
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo
  • Placebo — DRUG

Study Details

The aim of the study is to compare the effect of roflumilast on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of roflumilast.

Key Dates

Start date
Aug 31, 2005
Status verified
Sep 2016
Primary completion
May 31, 2007
Completion
Aug 31, 2007

Study Design

Enrollment
551 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Roflumilast 500 µg
  • Placebo Comparator: 2
    Placebo

Primary Outcome Measure

mean change from randomization to endpoint in lung function (post bronchodilator) [ Time Frame: 12 weeks ]

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