E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic obstructive pulmonary disease (COPD) of different severity |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009033 |
E.1.2 | Term | Chronic obstructive pulmonary disease |
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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 demonstrate that Erdosteine has anti-oxidative placebo-different effect that can be demonstrated by measuring the proposed sputum biomarkers
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E.2.2 | Secondary objectives of the trial |
To demonstrate that anti-oxidative effect of Erdosteine is also reflected by the improvement of phagocytotic activity of peripheral blood mononuclear cells (PBMC), oxidative biomarkers in exhaled breath and condensate, peripheral blood, lung function, symptoms and quality of life Secondary outcome variables: 1. exhaled breath condensate (8-isoprostane, LTB4) 2. exhaled multiple exhalation flow (MEFTeNO, Cal, JNO and DNO) 3. peripheral blood (8-isoprostanes; GSH; LTB4; total radical trapping antioxidant potential (TRAP) and Trolox equivalent antioxidant capacity (TEAC) 4. spirometry: FEV1, FVC, FEV1/FVC 5. Borg dyspnoea score 6. questionnaires (Hospital Anxiety and Depression Scale, St. George's Respiratory Questionnaire) 7. fat free mass measurements 8. pedometer measurements
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. COPD patients with FEV1/FVC <70% predicted defined as either stage moderate and severe diagnosis according to GOLD criteria (Global Strategy for the Diagnosis, Management, and Prevention of COPD) 2. Current (an active smoker with a pack history of >10 pack years) and ex-smokers 3. Patients will be allowed to use their current bronchodilators (anticholinergics and long-acting β2-agonists) and continued on their current dose of inhaled corticosteroids 4. Aged 38 - 80 years inclusive 5. Body mass index within the range 19-32 kg/m2 inclusive 6. FEV1 <15% reversibility (not % pred) after inhaled β2-agonists (200 μg salbutamol) 7. Stable COPD (no chest infection requiring antibiotics and/or oral steroids in the past 2 months) 8. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form 9. Available to complete the study
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E.4 | Principal exclusion criteria |
1. For female subjects of childbearing potential: pregnant or breast-feeding women, or lack of efficient contraception (i.e. contraceptive methods other than oral contraceptives, IUD, tubal ligature) 2. As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study 3. The subject regularly, or on average, drinks more than 21 units of alcohol per week 4. The subject has received antibiotics and/or oral steroids within 2 months of study entry
5. The subject has been hospitalised for a COPD exacerbation within 2 months of study entry
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E.5 End points |
E.5.1 | Primary end point(s) |
8-isoprostanes and LTB4 in induced sputum as markers of oxidative stress |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.6 | Cross over | Yes |
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) | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |