Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Roflumilast

added on to standard therapy for acute COPD exacerbations

Group Type ACTIVE_COMPARATOR

Roflumilast

Intervention Type DRUG

500 µg tablet, od, oral administration in the morning after breakfast

Placebo

added on to standard therapy for acute COPD exacerbations

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

tablet, od, oral administration in the morning after breakfast

Interventions

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Roflumilast

500 µg tablet, od, oral administration in the morning after breakfast

Intervention Type DRUG

Placebo

tablet, od, oral administration in the morning after breakfast

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No