E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Exacerbations of Chronic Bronchitis |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to evaluate the clinical efficacy of prulifloxacin in comparison with levofloxacin at the test of cure (TOC) visit, in the treatment of patients with AECB. |
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E.2.2 | Secondary objectives of the trial |
to evaluate clinical efficacy at long-term by follow-up visits (6 weeks, 6 months after end of treatment or next AECB);
to evaluate microbiological efficacy;
safety and tolerability.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
to evaluate the clinical efficacy of prulifloxacin in comparison with levofloxacin at the test of cure (TOC) visit, in the treatment of patients with AECB. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |