Effect of roflumilast on exacerbation rate in patients with COPD. A 52 weeks, double-blind study with 500 mcg roflumilast once daily versus placeboEfecto de roflumilast sobre la tasa de exacerbaciones en pacientes con EPOC. Un estudio doble ciego de 52 semanas, con 500 mg roflumilast una vez al día frente a placebo - HERMES
- Conditions
- Chronic obstructive pulmonary disease (COPD)Enfermedad Pulmonar Obstructiva Crónica (EPOC)MedDRA version: 8.1Level: lltClassification code 10010952
- Registration Number
- EUCTR2005-003938-18-ES
- Lead Sponsor
- ALTANA Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1500
· Written informed consent
· Age =40 years
· History of COPD for at least 12 months as defined in the ATS/ERS consensus statement (Standards for the Diagnosis and Management of patients with COPD, 2004) and chronic productive cough for 3 months in each of the 2 years prior to baseline visit V0 (if other causes of productive cough have been excluded)
· FEV1/FVC ratio (post-bronchodilator) = 70%
· FEV1 (post-bronchodilator) = 50% of predicted
· At least one documented COPD exacerbation (as defined by the need for oral or parenteral glucocorticosteroid intake and/or hospitalization) within one year prior to study baseline visit V0
· Not suffering from any concomitant disease that might interfere with study procedures or evaluation
· Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 20 pack years
· Availability of a chest x-ray or CT-scan dated a maximum of 6 months prior to study baseline visit V0 or willingness to have a chest x-ray or CT-scan performed at visit V0
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
· COPD exacerbation indicated by a treatment with oral or parenteral glucocorticosteroids and/or hospitalization not resolved at V0
· Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease [e.g. fibrosis, silicosis, sarcoidosis], and active tuberculosis)
· Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
· Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
· Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized or post-menopausal > 1 year or who are not using any other method of contraception considered sufficiently reliable by the investigator in individual cases
· Chronic gastrointestinal disorders associated with a history of recurrent gastrointestinal bleedings within the last 12 months preceding the baseline visit V0
· Participation in another clinical study (use of investigational product) within 30 days preceding the baseline visit V0
· Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0
· Use of disallowed drugs
· Use of immunosuppressive medications within 4 weeks prior to baseline (e.g. cyclosporine, methotrexate, TNF alpha receptors or antibodies, gold, azothiaprine)
· Known alpha-1-antitrypsin deficiency
· Known infection with HIV and/or active hepatitis
· Diagnosis, treatment, or remission of any cancer (other than basal cell carcinoma) within 5 years prior to study start,
· Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray/CT-scans/ ECG) that are not related to COPD and that require further evaluation
· Clinically relevant ECG findings (e.g. acute or recent myocardial infarction, clinically significant arrhythmia)
· Alcohol or drug abuse
· Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
· Patients not able to follow study procedures e.g. language problems, psychological disorders
· Suspected non-compliance
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method