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

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Anti-Inflammatory Agents

Criteria

Major Inclusion Criteria:

• Giving written informed consent

• History of COPD (according to GOLD 2009) for at least 12 months prior to baseline visit V0 associated with chronic productive cough for at least three months in each of the two years prior to baseline visit V0 (with other causes of productive cough excluded)

• Outpatients 40-80 years of age

• Post-bronchodilator 30% ≤FEV1 ≤80% predicted

• Post-bronchodilator FEV1/FVC ratio ≤70%

• Current or former smokers with smoking history ≥20 pack years

Main Exclusion Criteria:

• Criteria affecting the read-out parameters of the trial:

• Clinical instability, defined as experiencing a COPD exacerbation six months prior to V0

• An upper/lower respiratory tract infection which has not resolved four weeks prior to V0

• Diagnosis of asthma and/or other relevant lung disease

• Known alpha-1-antitrypsin deficiency

• Suspicion or diagnosis of a bleeding disorders irrespective of its pathophysiological mechanism

• Other protocol-defined exclusion criteria may apply