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 个研究点目标入组 0 人开始时间: 2004年9月23日最近更新: 2021年9月7日

适应症

试验速览

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•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

•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 *

发起方

Bayer plc