EUCTR2004-000404-40-IEActive, not recruitingPhase 1
A double-blind, randomised, placebo controlled study to investigate chronic intermittent pulse” therapy of moxifloxacin as a prevention of acute exacerbation in out-patients with chronic bronchitis. - PULSE
Bayer plc0 sites0 target enrollmentStarted: August 11, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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 *
Investigators
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