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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
EUCTR2004-000404-40-ES |
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Date of registration:
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23/09/2004 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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20/10/2004 |
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Target sample size:
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1132 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000404-40 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Ireland
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Italy
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Spain
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Key inclusion & exclusion criteria
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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 *
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic bronchitis
Classification code 10008841
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Intervention(s)
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Trade Name: ACTIRA
Product Name: BAY 12-8039 Tablets
Product Code: BAY 12-8039
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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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.
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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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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
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Secondary ID(s)
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2004-000404-40-IE
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BAY 12-8039/11229
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N/A
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 08/10/2004
Contact:
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