acute exacerbation of chronic bronchitis MedDRA version: 9.1 Level: LLT Classification code 10000743 Term: Acute exacerbation of chronic bronchitis
Conditions
Interventions
Trade Name: Avalox p.o. (film coated tablet)
Product Name: moxifloxacin
Product Code: BAY12-8039
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: moxifloxacin
CAS Number: 186826-86-8
Curre
Sponsors
Bayer HealthCare AG, Leverkusen, Germany
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Outpatients with chronic bronchitis 2.Male or female subjects, greater than or equal to 60 years old 3.Subject who can be managed with oral antimicrobials 4.Post bronchodilatory FEV1 less than or equal to 60% predicted and FEV1/FVC less than 70% at enrollment. 5.Documented history of 2 or more AECB episodes, within 12 months of study enrollment, requiring a course of systemic antibiotics and/or systemic corticosteroids 6.All symptoms/signs must be present and confirmed by the Investigator: •Increase in dyspnea •Purulent sputum •Increase in sputum volume 7.Subject must provide a sputum sample. The sputum will be assessed macroscopically by the investigator and should be graded as either yellow, green or rust (according to the provided color chart). 8.Current or past cigarette smoker with great than or equal to 20 pack year smoking history 9.Subjects must be exacerbation-free for at least 30 days prior to enrollment 10.Subjects must be willing and able to complete the questionnaires and subject booklet without assistance 11.Subjects with medical conditions and social status at the time of enrollment compatible with study protocol procedures 12.Willing and able to provide written informed consent 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
Exclusion criteria: 1.Known hypersensitivity to quinolones, ß-lactams, or to any of the excipients of the study drugs 2.Pregnant or breast feeding women (women of childbearing potential, based on investigator assessment must have negative urinary pregnancy test). 3.Known to have congenital or acquired QT prolongation 4.Known to have clinically relevant bradycardia 5.Known to have clinically relevant heart failure with reduced left ventricular ejection fraction 6.Known to have previous history of symptomatic arrhythmias 7.Taking QT prolonging drugs, for example class IA or III antiarrhythmic agents (e.g., quinidine, procainamide, amiodarone, sotalol), neuroleptics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, certain antihistaminics (e.g., terfenadine, astemizole, mizolastine), certain antimicrobials (sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine) or other QT prolonging drugs (e.g., cisapride, vincamine iv, bepridil, and diphemanil) 8.Known electrolyte disturbances that are not controlled, particularly uncorrected hypokalemia 9.Known history of hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose galactose malabsorption 10.History of a tendon disease/disorder 11.Known history of liver dysfunction (Child-Pugh C), including known elevated transaminases (ALT and/or AST greater than 5 times the upper limit of normal) 12.Known severe renal impairment with glomerular filtration rate of 15% reversibility or at least 200 mL) bronchial carcinoma, active pulmonary tuberculosis, known diffuse bronchiectasis, cystic fibrosis or pneumonia (a chest X-ray is not mandatory) 16.Known history of chronic colonization of pathogenic organisms resistant to moxifloxacin and/or amoxicillin clavulanic acid (e.g., Pseudomonas aeruginosa, MRSA) 17.Receiving long term (>4 consecutive weeks) systemic corticosteroid treatment (>10 mg/day of prednisolone or equivalent) 18.Received short course of systemic corticosteroid treatment within 30 days prior to enrollment 19.Unable to take oral medication 20.Life expectancy of less than 6 months 21.Receiving systemic antibacterial therapy within 30 days prior to study enrollment 22.Requiring concomitant systemic antibacterial agents 23.Use of any investigational drug or device within 30 days of screening, or previously enrolled in this study 24.Requiring home ventilatory support (subjects requiring home/portable oxygen therapy or CPAP for sleep apnea are not excluded) and/or those who have a tracheotomy in situ 25.History of liver function disorders following previous treatment with amoxicillin-clavulanic acid 26.Receiving disulfiram therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the efficacy of moxifloxacin 400 mg PO OD for five days with the respective efficacy of amoxicillin clavulanic acid 875/125 mg PO BID for seven days in the treatment of subjects with AECB. The primary efficacy endpoint will be clinical failure rates at 8 weeks post-therapy visit in outpatients with AECB. Clinical failure is defined as the requirement for additional or alternate treatment (including increased dose or duration of treatment) for an exarcerbation of respiratory symptoms with systemic antibiotics and/or systemic corticosteroids and/or hospitalization with systemic antibiotic and/or systemic corticosteroid administration within 8 weeks post therapy.;Secondary Objective: The secondary objectives will compare the following between the two treatment groups: •Clinical failure rates •Bacteriological eradication rates •Clinical failure rates (for subjects with positive sputum culture at enrollment; for each stratum) •Weekly mean symptom scores measured by the AECB-Symptom Scale (AECB-SS) •Rates and speed of symptom relief measured by the AECB-SS •Need for any change in dosage or additional respiratory medication such as bronchodilators and inhaled steroids, excluding short acting bronchodilators •Improvement in symptom burden measured by the AECB-SS •Improvement in health-related QoL measured by The St. George’s Hospital Respiratory Questionnaire (SGRQ) • Spirometry tests will be compared between treatment groups at each assessment visit •Healthcare resource utilization/consumption related to chronic bronchitis management •Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrhea;Primary end point(s): The primary efficacy criterion are clinical failure rates at the follow-up visit 8 weeks after end of treatment. Clinical failure is defined as the requirement for additional or alernate treatment (including increased dose or duration of treatment) | — |
Countries
Belgium, Czech Republic, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed