Prulifloxacin versus levofloxacin in the treatment of patients with Acute Exacerbations of Chronic Bronchitis (AECB)

Conditions: Acute Exacerbations of Chronic Bronchitis

Registration Number: EUCTR2006-004167-56-PT

Lead Sponsor: A.C.R.A.F. S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1) Male or female in- and out-patients with age between 40 and 75 years with no limitation of race. Female patients of childbearing potential are required to use an highly effective contraceptive method (implants, injectables, copper and hormonal IUDs, sexual abstinence, vasectomised partner) [CPMP/ICH/286/95] and to have a negative pregnancy test.

2) Patients 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.

3)Patients with moderate-to-severe deterioration of lung function, showing a FEV1 value less or equal than 50% of the predicted value.

4)Patients requiring starting concomitant systemic corticosteroids administration (20- 40 mg/day for 7 days), or chronically corticosteroid-treated in which an increase of the daily dosage is required.

5)Availability of a valid sputum specimen of broncho-pulmonary origin for microbiological evaluation obtained by either expectoration, suction, bronchoscopy or bronchial lavage. Valid samples will be characterized by < 10 squamous epithelial cells and > 25 polymorph nuclear leucocytes per low-power magnification 100x field.

6)Negative chest radiography to rule out pneumonia and active tuberculosis.

7)Written informed consent to the trial signed and dated by the patient according to the local regulations, obtained prior to all activities related to the trial.

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

1)Hypersensitivity or allergy to antibacterial fluoroquinolones and/or to any component of the study medications.

2)Underlying asthma.

3)Pregnancy and breast feeding.

4)History of tendinopathy.

5)Recent or past history of psychiatric illness or epilepsy.

6)Recent or past history of cardiac disease or rhythm disorders or clinically significant ECG abnormalities.

7)Latent or known deficiencies for the glucose-6-phospste dehydrogenase activity.

8)Known severe hepatic and/or renal insufficiency (AST, ALT and/or creatinine levels more than twice as high as the Upper Laboratory Norm, ULN). Should laboratory data not be available when treatment is required, the patient may be conditionally enrolled.

9)Other lower respiratory tract illness: severe bronchiectasies, cystic fibrosis, or pulmonary malignancy.

10)Concurrent infections and /or neoplasm.

11)Concomitant treatment with hypoglycemic drugs.

12)Patients under treatment with fenbufen and xanthines. Patients treated with xanthines could however be recruited if plasma levels were monitored; if plasma levels exceeded concentrations of 10-15 micrograms/ml, the daily dosages of xanthines should be lowered by the Investigator;

13)Treatment with antibiotics or antibacterials within the previous week;

14)Treatment with experimental drugs in the previous 4 weeks.