E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 5.1 |
E.1.2 | Level | llt |
E.1.2 | Classification code | 10003553 |
|
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 compare the effect of 500µg roflumilast p.o. once daily administered in the morning with the evening administration for 6 weeks on pulmonary function in patients with asthma |
|
E.2.2 | Secondary objectives of the trial |
To compare symptoms and the use of rescue medication; to investigate safety and tolerability of roflumilast administered in the morning versus evening administration; to determine plasma levels of roflumilast and the major metabolite roflumilast N-oxide |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- diagnosis of persistent bronchial asthma (GINA guidelines 2002) - 12 to 70 years old - baseline FEV1 50-85% in patients either untreated or receiving short-acting or long-acting bronchodilators, DSCG, nedocromil, anticholinergics, theophylline /aminophylline, lipoxygenase inhibitor, leukotriene antagonists, alone or in combination - baseline FEV1 60-90% in patients receiving not more than 500µg BDP-CFC or equivalent and/or in combination with any other asthma medication mentioned above |
|
E.4 | Principal exclusion criteria |
poorly controlled asthma diagnosis of COPD and/or other relevant lung diseases heavy smokers liver insufficiency, active hepatitis, known infection with HIV lower airway infection in the last 4 weeks prior to baseline period (B0) diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start alcohol or drug abuse suspected hypersensitivity and/ or contraindication to any ingredient of the study medication or rescue medication pregnancy, nursing, oocyte donation or oocyte implantation planned during the trial participation in another clinical study (use of investigational product) within 30 days preceding the baseline visit B0 or re-entry of patients already enrolled in this trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean change from randomization to endpoint in forced expiratory volume in one second (FEV1) |
|
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 | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |