E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Obstructive Pulmonary Disease |
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MedDRA Classification |
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 objectives of this study are to assess the effect of high dose NAC (1800 mg): •On small airways by measuring the total and peripheral airway resistance calculated with CFD •On oxidative stress by measuring exhaled NO and oxidative stress markers (CRP, erythrocyte sedimentation rate, glutathione, GPX, SOD, IL-8, IL-6 and 8-isoprostane) in blood and EBC measured at baseline, after 12 weeks of placebo and 12 weeks of NAC.
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to assess: •Dynamic and static lung volumes by spirometry, body plethysmography and diffusion •Quality of life by the SGRQ •Tolerability and safety of high dose NAC.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Patients with documented COPD based on the following criteria: •Smoking history of at least 10 pack-years •Decreased Tiffeneau index (FEV1/(FVC < 0.70) 2.Patients aged ≥ 40 years 3.Patients who stopped smoking since more than 1 month 4.Patients who present moderate COPD with an FEV1 between 50 and 80% of predicted (GOLD 2) 5.Patients should be treated according to GOLD guidelines
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E.4 | Principal exclusion criteria |
1.Unstable patients who developed an exacerbation during the last 8 weeks 2.Patients who are current smokers or stopped less than 1 month 3.Patients who are allergic to acetylcysteine or to another element of the product 4.Patients with phenylketonurie or an untreated active peptic ulcer 5.Patients with any stage kidney and/or heart insufficiency or hypertension 6.Patients already treated with NAC for more than 6 months or during the last 3 months 7.Patients on continuous treatment with oral, inhalation, intravenous or intramuscular corticosteroids 8.Patients who are pregnant or are breast-feeding 9.Patients who are treated with orally administered cefalosporines 10.Patients using supplements containing antioxidants as vitamins C or E
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E.5 End points |
E.5.1 | Primary end point(s) |
Effect of delivery 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 | Yes |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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
| 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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |