E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10008841 |
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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 objectives of the study are to compare the long-term benefits of moxifloxacin administered as chronic intermittent pulsed suppressive therapy for the prevention of acute exacerbations versus placebo. The primary objective of the study will be to assess the frequency of acute exacerbations of chronic bronchitis between the moxifloxacin treated group and the placebo group during the 48 week treatment period. Another key objectives of this study, beside different efficacy comparisons, will be to evaluate prospectively, the impact of treatment on health-related quality-of-life and the consumption of health care resources.
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E.2.2 | Secondary objectives of the trial |
Assess the frequency of acute exacerbations between the two treatment groups after 24 and at 72 weeks; compare deterioration in lung function, time to first exacerbation, length and severity of each exacerbation; compare impact of treatment on health related QoL; compare impact on symptom burden; assess rate of bacterial resistance development, bacterial load and inflammatory markers in sub-group of subjects; compare health care resource utilisation; changes in chronic bronchitis maintenance therapy; safety & tolerability of pulsed moxifloxacin |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male or female out-patients, Aged > 45 year * Subjects suffering from chronic bronchitis (WHO Criteria - Chronic bronchitis is defined as a cough productive of sputum on most days, for three consecutive months for at least two consecutive years) * FEV1 < 70% and FEV1/FVC < 70% predicted from age, height and sex * No documented episode of AECB (requiring treatment) within 6 weeks of randomisation and not experiencing an exacerbation at the time of screening * Sputum production, on most days, even when exacerbation-free * Presented with at least two documented (i.e. requiring antibiotics and / or systemic steroids administration) acute exacerbation episodes during the last 12 month * If receiving chronic therapy with inhaled long acting bronchodilators and/or inhaled or systemic steroids the treatment must have remained stable for the proceeding 6 weeks to prior to screening * Smoking history of at least 20 pack-years |
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E.4 | Principal exclusion criteria |
Known hypersensitivity to moxifloxacin or other quinolones * History of tendon disease/disorder related to quinolone treatment * Known congenital or documented-acquired QT prolongation; uncorrected hypokalaemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left-ventricular ejection fraction; previous history of symptomatic arrhythmias; concomitant use of any of the following drugs, reported to increase the QT interval: antiarrhythmics class IA (e.g., quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (e.g., amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g., phenthiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressive agents, certain antimicrobials (sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), others (cisapride, vincamine IV, bepridil, diphemanil) * Subjects who are actively participating in intensive Pulmonary Rehabilitation Programs * Subjects with a known history of chronic colonisation of pathogenic organisms resistant to moxifloxacin e.g. pseudomonas, MRSA * No systemic or inhaled antibiotic therapy during the 6 weeks prior to screening and no long term antibiotic usage * |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure for the study is the assessment of the frequency of acute exacerbations of chronic bronchitis between the moxifloxacin group and the placebo group during the 48-week 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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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.8.5 | 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 | 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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |