Chronic bronchitis Classification code 10008841
Conditions
Interventions
Trade Name: Avelox 400mg Tablets
Product Name: Moxifloxacin Tablets
Product Code: BAY 12-8039
Pharmaceutical Form: Film-coated tablet
IN
Sponsors
Bayer plc
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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;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. | — |
Countries
Ireland, Italy, Spain
Outcome results
None listed