Acute Exacerbation of Chronic Bronchitis MedDRA version: 9.1 Level: LLT Classification code 10006458 Term: Bronchitis chronic
Conditions
Interventions
Trade Name: KETEK
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Telithromycin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-
Pharmaceutical for
Sponsors
REPLIDYNE, INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or non-pregnant female outpatients age > or = to 35 years with significant COPD (GOLD criteria I, IIA or IIB), chronic cough and sputum production and an acute exacerbation Have a history (past or current) of smoking (>10 pack-years) Have evidence of airflow obstruction (within the year prior to the current exacerbation or during the current exacerbation and then reconfirmed after recovery), defined as: ?Forced expiratory volume in one second (FEV1) % predicted >35 and ?Ratio of FEV1 to forced vital capacity (FVC) of 2 successive years ?All of the following cardinal symptoms of exacerbation must be present: ?Increase in or worsening of cough ?Increase in or worsening of dyspnea ?Increase in sputum volume ?Increase in sputum purulence Patient must provide a purulent or muco-purulent sputum by deep expectoration for culture and susceptibility testing on the day of study enrollment 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of hypersensitivity to faropenem medoxomil or any of the components of the product or a history of an anaphylactic reaction to β-lactams (e.g., penicillins or cephalosporins) History of hypersensitivity to telithromycin or any member of the macrolide family of antibiotics Chest X-Ray or other radiographic documentation of an underlying pneumonia Known lung or chest cavity malignancy active within the past 5 years Known concurrent medically active condition likely to interfere with the evaluation of efficacy (e.g., pulmonary tuberculosis, bronchiectasis, cystic fibrosis, etc.) Known neutropenia (< 1000 cells/mm3), or CD4 counts of <200 cells/mm3, or on highly active antiretroviral therapy (HARRT). An HIV test is not required. The need for hospitalization or intravenous antibiotics Hospitalization for any cause within two weeks prior to study entry, lasting for 48 hours or more Any previous course of a systemic antibacterial within the last 2 weeks Subjects receiving concomitant therapy with any of the following medication(s): Class IA (e.g., quinidine, procainamide) or Class III (e.g., dofetilide) antiarrhythmic agents, HMG-CoA reductase inhibitors (e.g., simvastatin, lovastatin, atorvastin), rifampin, phenytoin, carbamazepine, phenobarabital, cisapride, or pimozide. Subjects with heart failure taking metoprolol Patients with a personal or family history of QTc prolongation or proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, or clinically significant bradycardia Pateints with myasthenia gravis Patients with a previous history of hepatitis/jaundice associated with the use of telithromycin (KETEK)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this trial are to: - Demonstrate the superiority of faropenem medoxomil versus placebo, in terms of clinical response, in the treatment of subjects with a microbiologically documented acute exacerbation of chronic bronchitis - Demonstrate the non-inferiority of faropenem medoxomil versus telithromycin, in terms of clinical response, in the treatment of subjects with a clinically documented acute exacerbation of chronic bronchitis - Differentiate the safety/tolerability profile of faropenem medoxomil to that of telithromycin especially in terms of the incidence of gastrointestinal disorders;Primary end point(s): The primary analysis will begin with the comparison of the clinical response rates of faropenem medoxomil to placebo at the Test-of-Cure visit in the modofied Intent-to-Treat population;Secondary Objective: The secondary efficacy objectives will include: - Clinical response (as measured by clinical signs and symptoms) and sputum purulence at the During Therapy Visit (Day 2 to 5) will be compared between treatments groups in the clinically evaluable population - Clinical response at the TOC Visit in the Intent-to-Treat (ITT) population - Clinical response at the Late Post-Therapy Follow-up Visit in the clinically evaluable population - Patient Reported Outcomes using a Clinical COPD Questionnary (see Appendix 4 of the protocol)at Visit 1 (Pre-Therapy), Visit 2 (During Therapy), Visit 3 (Test of Cure)and Visit 4 (Late Post-Therapy Follow-up). | — |
Countries
Bulgaria, Italy, Latvia
Outcome results
None listed