E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute exacerbations in patients suffering from COPD (stage II - III according GOLD) |
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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 | 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 |
The primary objective of the study is to show that Broncho-Vaxom® decreases significantly the rate of exacerbations by at least 20% when compared with placebo in patients suffering from Stage II and III of COPD, respectively. |
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E.2.2 | Secondary objectives of the trial |
The secondary efficacy variables are: · Type, severity and duration of the acute exacerbations. · Type and duration of prescribed concomitant treatment(s). · Use of healthcare resources, hospitals and other institution. · The duration of absenteeism from work. · Number and duration of hospitalization. · Spirometry with FEV1/FVC will be performed for each participant at Visit 1 and 6. · St Georges Respiratory Questionnaire : the scores for each section including symptom score (frequency and severity), activity score (activities that cause or are limited by breathlessness), and impact score (social functioning, psychological disturbances resulting from airways disease), as well as a total score will be calculated using established methods. · The SGRQ has been translated into 27 languages and a validated translation is available for each patient. · Global assessment of efficacy.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Patients of either sex. • Patients aged >/= 40 years. • History of documented AECBs >/= 2 in the previous year, and COPD Stage II to III, respectively. •30% </= FEV1< 80% (value after bronchodilator test), predicted, documented within 6 months prior to the enrolment in the study. • Smokers with a history of 20 packs year or more; active or past smokers. • Patients having given their written informed consent. |
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E.4 | Principal exclusion criteria |
• Patients with asthma. • Patients with mucoviscidosis. • Patients with bronchiectases. • Any known disseminated malignancy. • Known chronic systemic infections or inflammatory conditions (e.g. rheumatoid arthritis, systemic lupus erythematosis, active sarcoidosis). • Previous solid organ transplantation. • Myocardial infarction or cerebrovascular accident within the past 6 months prior to study enrolment. •Patients with a known allergy or previous intolerance to the study medication. •Female patients who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the rate of acute exacerbations recorded in the 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 | 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 | 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) | No |
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 | 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 | 22 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 47 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 28 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 28 |