Randomized, single-blind, parallel groups, controlled study to compare levofloxacin and prulifloxacin in patients with exacerbations of COPD previously treated with different antibiotics and admitted to Internal Medicine Departments - ND

Active, not recruiting

• Conditions: -Patients with acute exacerbation of COPD of possible infectious origin, previously treated with antibiotic therapy (no quinolones), without clinical improvement, and hospitalized in Internal Medicine Departments

• Registration Number: EUCTR2008-003842-27-IT
• Lead Sponsor: CENTRO STUDI FADOI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Patients with acute exacerbation of COPD of possible infectious origin, previously treated with antibiotic therapy (no quinolones), without clinical improvement, and hospitalized in Internal Medicine Departments
-presence of sputum purulence, plus at least two of the following, lasting for more than three days
increased cough
increased dyspnea
increased sputum volume
-age ≥ 60 years
-FEV1 < 80% e &#8805;30% and FEV1 / CVF ratio < 70 %
-no inflammation at chest X-ray
-informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

-Asthma
-lung cancer
-known quinolone hypersensitivity
-no possibility of oral administration, or altered absorptive function by gastrointestinal system

-history of epilepsy, convulsions, cerebrovascular disease (stroke in the previous six months)

-history of tendinopathy

-severe known renal insufficiency or creatininemia > 2 times the upper limit of normal range, or liver insufficiency (AST and/or ALT > 2 times the upper limit of normal ranges)

-sepsis, tubercolosis or other infectious diseases

-cystic fibrosis

-genetic defects of galactose tolerance, defect of lactase or altered absorption of glucose-galactose, or defect of glucose-6-phosphate-deydrogenase enzyme

-pregnancy or lactation

-drug or alcohol abuse

-concomitant treatment with experimental drugs

Study & Design

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