Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease

Sponsor
AstraZeneca
Study ID
NCT01509677
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    500 μg tablet, once daily, oral administration in the morning after breakfast
  • Placebo — DRUG
    tablet, once daily, oral administration in the morning after breakfast

Study Details

The objective of the Biopsy trial is to investigate the effect of roflumilast 500 µg tablets once daily versus placebo on inflammation parameters in bronchial biopsy tissue specimen and additional in sputum and blood serum. Also data on safety status will be obtained. Patients to be included required to have moderate to severe COPD associated with chronic bronchitis. The total duration of this randomized, multicentre, phase III trial is 24 weeks maximum.

Key Dates

Start date
Feb 1, 2012
Status verified
Nov 2019
Primary completion
Feb 1, 2016
Completion
Feb 1, 2016

Study Design

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

Arms

  • Active Comparator: Roflumilast
    500 μg tablet, once daily, oral administration in the morning after breakfast
  • Placebo Comparator: Placebo
    tablet, once daily, oral administration in the morning after breakfast

Primary Outcome Measure

Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. [ Time Frame: 16 weeks ]

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