E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute exacerbation 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 |
The primary objective of the study is to demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in the reduction of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides at the Test Of Cure visit in the sputum of patients with Sp detected at the start of the study (Visit 1). |
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E.2.2 | Secondary objectives of the trial |
· To demonstrate the superiority of telithromycin over azithromycin and over cefuroxime axetil in achieving clinical cure and Sp eradication success at the Test Of Cure visit in patients with Sp detected in sputum specimen at the start of the study (Visit 1); · To compare the clinical cure rates achieved by each treatment group in the penicillin or erythromycin resistant Sp (PERSp) population with the cure rates in the sensitive Sp (SSp) population at End of Therapy and Test Of Cure visits; · To compare the effect of telithromycin, azithromycin and cefuroxime axetil at End of Therapy visit on the presence of Streptococcus pneumoniae strains resistant to beta-lactams or macrolides in the sputum of patients with Sp detected at the start of the study (Visit 1); · To compare the clinical efficacy at the End of Therapy visit and safety at the Test Of Cure visit of telithromycin, azithromycin and cefuroxime axetil in the “global” randomized population.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patients meeting all of the following criteria will be considered for enrollment into the study: · Outpatients, male or female, aged 35 years or older · Patient with a documented history of chronic bronchitis, characterized by cough and excessive sputum production for most days of at least three months for 2 consecutive years, And · Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis, presumed due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume; · Patients producing spontaneous sputum; · Patients with three or less AECB in the previous 12 months
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E.4 | Principal exclusion criteria |
· Patients with a known diagnosis of bronchiectasis, cystic fibrosis, lung cancer or lung metastases, active pulmonary tuberculosis or with suspected pneumonia; · Patients with present acute respiratory failure or patients requiring aggressive airway management; · Hospitalized patients and patients from institutional care facilities; · Patients treated with antibiotics within 14 days prior to enrollment; · Patients who are receiving other medications, including systemic antimicrobial agents, or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety; · Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) making either implementation of the protocol or interpretation of the study results difficult; · Patients with a progressively fatal disease, or life expectancy ≤ three months; · Patients who have received any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period; · Patients with a recent (within the previous three months) history of alcohol or drug abuse; · Immunocompromised patients including but not limited to: Patients with known HIV infection (CD4 + <200/mm3), known neutropenia (<1500 neutrophils/mm3), chronic corticosteroid therapy (³ 10mg/day prednisolone equivalent during at least three months), immunodepressant treatment within the previous six months, splenectomized patients or patients with known hyposplenia or asplenia; · Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study; · Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and are unlikely to complete the study; · Patients having received anti-pneumococcal immunization in the previous six months before study entry; · Patients with suspected or known hypersensitivity to, or suspected serious adverse reaction to the study medication, or to ß-lactams or macrolides classes of antibiotics; · Patients diagnosed with myasthenia gravis; · Women who are breast-feeding or who are pregnant; · Women who are of childbearing potential who do not agree to use an approved contraceptive method during the study; · Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption; · Patients with a known history of long QTc syndrome (e.g., personal or family history of syncope or arrhythmia); · Patients treated within 2 weeks prior to study entry, or requiring treatment during study medication, with CYP3A4 inducers such as rifampicin, phenytoïn, carbamazepine, phenobarbital, and St John’s Wort; · Patients requiring treatment during the study period with drugs not permitted by the clinical study protocol (see section 6.2); · Patients known to have impaired hepatic function; · Patients known to have impaired renal function; · Patients already enrolled in this study
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E.5 End points |
E.5.1 | Primary end point(s) |
· Presence of PERSp in sputum of patients at the TOC Visit (Visit 3) in each treatment group and who were Sp positive in sputum at Visit 1. |
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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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | 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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End of the Trial = Last Patient Last Visit |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 25 |