Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo Versus Telithromycin In the Treatment of Acute Exacerbation of Chronic Bronchitis - ND

• Conditions: Acute Exacerbation of Chronic Bronchitis; MedDRA version: 9.1Level: LLTClassification code 10006458Term: Bronchitis chronic

• Registration Number: EUCTR2006-003944-42-IT
• Lead Sponsor: REPLIDYNE, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

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 <0.70 Have a clinical diagnosis of AECB defined as: ?Cough and sputum production on most days for at least 3 consecutive months for > 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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified