Effect of roflumilast on exacerbation rate in patients with COPD treated with fixed combinations of LABA and ICS. A 52-week, randomised double-blind trial with roflumilast 500 µg versus placebo.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

2. History of COPD (according to GOLD 2009) for at least 12 months prior to baseline Visit V0 associated with chronic productive cough for 3 months in each of the 2 years prior to baseline Visit V0 (with other causes of productive cough excluded).
3. Age >= 40 years
4. Forced expiratory volume after one second (FEV1) / forced vital capacity (FVC) ratio (post-bronchodilator) < 70%
5. FEV1 (post-bronchodilator) <= 50% of predicted
6. At least two documented moderate or severe COPD exacerbations, separated by at least 10 days, within one year prior to baseline visit V0.
7. Patients must be pre-treated with LABA and ICS for at least 12 months before baseline Visit V0. Up to 3 months before baseline Visit V0 free or fixed combinations of LABA and ICS are allowed, including changes in dose, active substances, and brands. In the last 3 months before baseline Visit V0 patients must be pre-treated with fixed combinations of LABA and ICS at a constant dose (maximum approved dosage strength of the combination)
8. Former smoker (defined as smoking cessation at least one year ago) or current smoker both with a smoking history of at least 20 pack years.

Exclusion Criteria

1. Moderate or severe COPD exacerbations and/or COPD exacerbations treated with antibiotics ongoing at the baseline visit V0
2. Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0
3. Diagnosis of asthma and/or other relevant lung disease
4. Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0. However, physical exercise maintenance following the completion of the initial pulmonary rehabilitation program and which is continuously performed within 3 months preceding baseline Visit V0 and during the complete trial is allowed.
5.Known alpha-1-antitrypsin deficiency.;Exclusion criteria within ethical considerations in terms of general health are listed in the protocol, section 6.2.2.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>Rate of moderate or severe COPD exacerbations per patient per year. Moderate<br /><br>exacerbations are defined as requiring oral or parental glucocorticosteroids,<br /><br>severe as requiring hospitalisation and/or leading to death. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key-secondary endpoints:<br /><br>- Change from randomisation (V2) over 52 weeks of treatment in<br /><br>post-bronchodilator FEV1.<br /><br>- Rate of severe COPD exacerbations per patient per year.<br /><br>Other secondary endpoints are described in protocol section 11.</p><br>