E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute exacerbation of chronic-obstructive pulmonary disease. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029978 |
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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, in explorative manner, in adult patients with mild-moderate AECOPD, treated orally with telithromycin 800 mg od for 5 days the pharmacokinetic profile of telithromycin in plasma at the steady-state. |
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E.2.2 | Secondary objectives of the trial |
To describe the pharmacokinetic-pharmacodynamic profile of telithromycin in plasma at the steady-state;the relationship between the pharmacokinetic-pharmacodynamic profile of telithromycin in plasma at the steady-state and the clinical cure and satisfactory bacteriological response rate; the clinical and bacteriological response at the end of therapy visit D 6-7 ; the time to symptoms amelioration/resolution; the safety of telithromycin. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Adult inpatients, either sex, aged 18 years or older; documented history of mild-moderate chronic bronchitis/chronic obstructive pulmonary disease COPD as defined by ERS/ATS criteria and with a basal FEV1 / 50 and with FEV1 / FVC / 70 and who have had at least one or more episode of acute exacerbation in the previous year; clinical diagnosis of AECOPD based on the following clinical signs and symptoms at least two of any of the following Winnipeg II increased in sputum purulence change in color and/or increased in sputum volume and/or increased dyspnea with or without other symptoms like fever, cough, ect.; sufficient volumes of spontaneous sputum to permit collection of specimens for gram stain and bacteriological culture; negative chest radiography posterior/anterior and lateral views to rule out a diagnosis of pneumonia within 48 hours before initiation of study medication or at the latest 24 hours after initiation of study medication. |
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E.4 | Principal exclusion criteria |
Main criteria in relation with study protocol current asthma, with a known diagnosis of bronchiectasis, cystic fibrosis, lung cancer or lung metastases, or active pulmonary tuberculosis; acute respiratory failure or patients requiring aggressive airway management; requiring parenteral antibiotic therapy; treated with antibiotics within 30 days prior to enrollment; with a maintenance oral corticosteroid therapy; with known impaired renal function serum creatinine 1.5 mg/dL ; immunocompromission. Main criteria in relation with study treatment with known impaired hepatic function sGOT, sGPT or serum bilirubin more than 2-fold the normal values ; with suspected or known hypersensitivity to, or suspected serious adverse reaction to the study medication, or macrolide class of antibiotics; with a known history of long QTc syndrome e.g., personal or family history of syncope or arrhythmia ; treated within 2 weeks prior inclusion, or requiring treatment during study medication, with CYP3A4 inducers such as rifampicine, phenyto n, carbamazepine, phenobarbital, and St John s Wort; who will require on-study treatment with medications known to have contraindicated drug interactions with the study medication and/or macrolides, in general, including but not limited to ergot alkaloid derivatives, terfenadine, cisapride, astemizole, pimozide, bromocriptine, cabergoline, pergolide and statins for those patients who are not allowed to stop their statin treatment simvastatin, lovastatin, atorvastatin . |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary variable will be the pharmacokinetic evaluation at the steady-state conditions, that is after at least four days of unmodified treatment dose and time schedule . |
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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 | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |