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 | SOC |
E.1.2 | Classification code | 10038738 |
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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 |
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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 |
The primary objective of the study is to evaluate the efficacy of erdosteine, compared to placebo, in reducing the number of acute exacerbations over a 12-month treatment period in patients with moderate-to-severe COPD |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of the study will be to investigate the effects of erdosteine on chronic respiratory symptoms and health-related quality of life, pulmonary function parameters and exercise performance at the 6MWT. In addition, a pharmaco-economy evaluation of disease-related costs will be performed. The study will also evaluate the safety and tolerability of a long-term treatment with erdosteine. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Outpatients of both sexes, aged between 40 and 80 years, current or past cigarette smokers with an history of smoking of at least 10 pack-years. Diagnosis of COPD (Stage II and III according to GOLD 2007), with post-bronchodilator FEV1/FVC <70% and FEV1 between 30% and 70% pred. On a stable therapeutic regimen for COPD for at least 8 weeks prior to inclusion, and having experienced at least 2 acute exacerbations of COPD requiring medical intervention in the previous year. Presence of chronic COPD symptoms (cough, sputum production, dyspnoea), and a mean cough and sputum score (from BCSS) of at least 1.5 for ech symptom during run-in. Written informed consent to participate. |
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E.4 | Principal exclusion criteria |
Female subjects: pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential. Acute exacerbation of COPD within 8 weeks prior to inclusion. Treatment with antibiotics and/or systemic steroids and/or hospitalisation within 8 weeks prior to inclusion. COPD stage IV. Current or past diagnosis of asthma. Clinically significant or unstable concurrent disease, including significant pulmonary disease (e.g. tuberculosis, cystic fibrosis, bronchiectasis, lung cancer). Significant renal impairment as indicated by creatinine clearance < 25 ml/min. Active peptic ulcer. Long term oxygen therapy. Known or suspected hypersensitivity to erdosteine. Participation in another clinical trial with an investigational drug within 60 days prior to inclusion. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of acute exacerbations of COPD experienced by the patients in the two groups during the 12-month treatment period. |
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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 | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
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 | Yes |
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
|
La sperimentazione si concludera` con l`ultima visita dell`ultimo soggetto incluso |
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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 | 9 |
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 | 9 |