Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Effect of Roflumilast 500 μg Tablets Once Daily at Acute COPD Exacerbations Treated With Standard Therapy of Oral Steroids and Antibiotics. A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial

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.

Participants will be asked whether they agree to participate in the measurements of arterial stiffness. Participants who agree will be included in the substudy, with the target of 60 patients with arterial stiffness measurements to complete the trial.

Study was terminated due to difficulty in identifying further eligible patients for this exploratory study within a reasonable time.

Inclusion Criteria:

• Written informed consent (IC)
• Age ≥ 40 years
• History of COPD for at least 12 months prior to enrollment (Visit V0)
• Chronic productive cough for 3 months in each of the 2 years prior to enrollment (if other causes of productive cough have been excluded) and/or an exacerbation with predominantly bronchitic symptoms at enrollment
• Presentation of an acute exacerbation of COPD that will be associated with increased sputum volume or change in sputum colour
• Documented fixed airway obstruction determined by an FEV1/FVC ratio (post-bronchodilator) < 70% (if a pulmonary function test is not possible at Visit V0 a previous measurement can be taken which must not be older than 6 months)
• Former smoker (defined as: smoking cessation at least 1 year ago) or current smoker both with a smoking history of at least 10 pack years

Main Exclusion Criteria:

• Diagnosis of asthma and/or other relevant lung disease
• Known alpha-1-antitrypsin deficiency
• Recurrent exacerbations (within 8 weeks of a preceding exacerbation)
• Treatment of current exacerbation with oral corticosteroids and/or antibiotics already started at enrollment
• Treatment with PDE4 inhibitors within 3 months prior to Visit V0
• Other protocol-defined exclusion criteria may apply