Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Conditions

• Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

The purpose of this trial is to investigate if roflumilast can reduce the neutrophilic inflammation at acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). In addition, the potential benefit of roflumilast on severity and recovery periods of acute COPD exacerbations will be assessed using patient diaries and questionnaires.

Key Dates

Start date

Feb 29, 2012

Status verified

Aug 2016

Primary completion

Mar 31, 2014

Completion

Mar 31, 2014

Study Design

Enrollment

81 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Roflumilast
  added on to standard therapy for acute COPD exacerbations
• Placebo Comparator: Placebo
  added on to standard therapy for acute COPD exacerbations

Primary Outcome Measure

Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Initial Approach) [ Time Frame: Baseline and Day 14 ]