Prulifloxacin versus levofloxacin in the treatment of patients with Acute Exacerbations of Chronic Bronchitis AECB - ND

Conditions: Outpatient with acute exacerbations of chronic bronchitis
MedDRA version: 9.1Level: LLTClassification code 10061736Term: Bronchitis bacterial

Registration Number: EUCTR2006-004167-56-IT

Lead Sponsor: ANGELINI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 284

Inclusion Criteria

Male or female outpatients with age between 40 and 75 years with no limitation of race; with a diagnosis of Acute Exacerbations of Chronic Bronchitis characterized by the presence of the following three symptoms, or at least two including purulence increased dyspnoea; increased of sputum volume; increased of sputum purulence, that had to be confirmed macroscopically by the investigator. Chronic bronchitis is characterized by cough and excessive secretion of mucus and is diagnosed when patients report production of sputum on most days over at least three consecutive months for 2 or more consecutive years; 35 FEV1 80 of the predicted value; Negative chest radiography to rule out pneumonia and active tuberculosis.
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

Hypersensitivity or allergy to antibacterial fluoroquinolones and/or to any component of the study medications; Underlying asthma; Systemic corticosteroids treatment since 8804; 2 weeks before trial drug administration are excluded, unless patients are chronically treated treatment for 2 weeks before trial drug administration . Corticosteroid nasal spray administration is allowed in the first 3 days of the study drug administrations only.Childbearing potential where pregnancy is not excluded by pregnancy test in urine HCG , or lactation.History of tendinopathy. Recent or past history of cardiac disease or rhythm disorders or clinically significant ECG abnormalities. Other lower respiratory tract illness severe bronchiectasies, cystic fibrosis, or pulmonary malignancy. Concurrent infections and /or neoplasm. Concomitant treatment with hypoglycemic drugs.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the clinical efficacy at the Test Of Cure visit TOC , 7-10 days after the end of treatment.;Secondary Objective: to evaluate the long-term clinical efficacy at follow-up visits 6 weeks, 6 months after end of treatment or next AECB , to evaluate microbiological efficacy, safety and tolerability.;Primary end point(s): evaluation at the Test Of Cure visit TOC , 7-10 days after the end of treatment, of the clinical efficacy of prulifloxacin 600mg UID versus levofloxacin 500mg UID in the treatment of patients with acute exacerbations of chronic bronchitis.

Secondary Outcome Measures