E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Obstructive Pulmonary Disease COPD |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009026 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the effect of 500 mcg roflumilast once daily on exacerbation rate, pulmonary function, COPD symptoms, dyspnea, health related quality of life and health care resource use |
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E.2.2 | Secondary objectives of the trial |
To investigate the safety and tolerability of roflumilast |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
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 |
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E.4 | Principal exclusion criteria |
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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary variable Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids per patient per year Key-secondary variable Mean change from baseline V2 during the treatment period in post-bronchodilator FEV1 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |