Outpatient with acute exacerbations of chronic bronchitis MedDRA version: 9.1 Level: LLT Classification code 10061736 Term: Bronchitis bacterial
Conditions
Interventions
Trade Name: UNIDROX 5CPR RIV 600MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Prulifloxacin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Trade Name:
Sponsors
ANGELINI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Austria, Germany, Italy, Portugal, Spain
Outcome results
None listed