Status:
TERMINATED
Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
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 b...
Detailed Description
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 art...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01473758
Start Date
February 1 2012
End Date
March 1 2014
Last Update
February 14 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Academic Unit of Respiratory Medicine, Royal Free Hospital, Jadwiga A. Wedzicha
London, United Kingdom, NW3 2PF
2
London, United Kingdom