Trials / Terminated
TerminatedNCT01473758
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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 benefit of roflumilast on severity and recovery periods of acute COPD exacerbations will be assessed using patient diaries and questionnaires.
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Roflumilast | 500 µg tablet, od, oral administration in the morning after breakfast |
| DRUG | Placebo | tablet, od, oral administration in the morning after breakfast |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2014-03-01
- Completion
- 2014-03-01
- First posted
- 2011-11-17
- Last updated
- 2017-02-14
- Results posted
- 2016-10-24
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01473758. Inclusion in this directory is not an endorsement.