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 | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029978 |
E.1.2 | Term | Obstructive chronic bronchitis with acute exacerbation |
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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 assess the long term bronchodilator efficacy and benefit in terms of exacerbation control and disease-related health status and other secondary outcomes of LAS 34273 200 mcg administered once daily by inhalation for 52 weeks compared to placebo in patients with moderate to severe, stable chronic obstructive pulmonary disease COPD . |
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E.2.2 | Secondary objectives of the trial |
To evaluate the long term safety and tolerability of LAS 34273 200 g administered once daily for 52 weeks by inhalation compared to placebo in the same target population. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Males and non-pregnant, non-lactating females aged 40 years; Patients with a clinical diagnosis of COPD; Patients whose FEV1 at Visit 1 measured between 30-45 min post inhalation of 400 mcg of salbutamol is 80 of the predicted normal value; Current, or ex-cigarette smokers with a smoking history of at least 10 packs-year; Patients who are eligible and able to participate in the trial and who consent to do so in writing. |
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E.4 | Principal exclusion criteria |
History or current diagnosis of asthma, allergic rhinitis or atopy; Eosinophil count 600 cells/mm3; A respiratory tract infection or COPD exacerbation in the six weeks prior to Visit 1; Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to Visit 1 Use of long-term oxygen therapy; Clinically significant respiratory conditions; Clinically significant cardiovascular conditions; Patients in whom the use of anticholinergic drugs is contraindicated; Patients with any other serious or uncontrolled physical or mental dysfunction at the discretion of the investigator; Patients with a life expectancy of less than 1 year because of disease severity; Clinically relevant abnormalities in the results of laboratory; |
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E.5 End points |
E.5.1 | Primary end point(s) |
Trough forced expiratory volume in one second FEV1 Trough FEV1 is defined as the mean FEV1 value of the two greatest FEV1 readings measured at 23 and 24 hours after the administration of the investigational medicinal product IMP . The primary timepoint will be trough FEV1 values at the end of the first 28 weeks of treatment. |
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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 | Yes |
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 | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |