E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Assessment of microbiological efficacy and tolerability of inhaled tobramycin vs placebo in cystic fibrosis patients, primo colonised by Pseudomonas aeruginosa justified inhaled antiobiotherapeutical treatment during 28 days.
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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 assess bactericidal efficacy on Pseudomonas aeruginosa of inhaled Tobramycin Erempharma® administered for 28 days : 300 mg per day (2 inhalations of 150 mg each) by Aeroneb.
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E.2.2 | Secondary objectives of the trial |
- To assess inhibitor ratio of inhaled tobramycin on P. aeruginosa in patients (C/CMI) and modifications during treatment - To assess safety of inhaled tobramycin - Evaluer l’impact des aérosols sur la flore bactérienne de l’expectoration - To assess microbiological impact on staphylococcus aureus in cas of associated colonization - To assess the improvement of P. aeruginosa bacterial charge during follow-up
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male and female patients aged > 12 months, with cystic fibrosis (genetical study or TdS > 60 meq/l). - primo colonization by Pseudomonas aeruginosa and receiving antibiotic treatment according consensus conference.
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E.4 | Principal exclusion criteria |
- inhaled antibiotic treatment during previous 28 days before study - Concommittent traitement or during previous 28 days of folowwing antiobiotic: Ticarcilline, Ticarcilline + clavulanic Acid, Piperacilline, Piperacilline + Tazobactam, Ceftazidime, Cefepime, Meropeneme, Aztreonam, Colistine, Rifampicine, Cefotaxime, Imipeneme, Gentamicine, Tobramycine, Amikacine, Norfloxacine, Ciprofloxacine, Fosfomycine - chronical or occasional colonisation by Pseudomonas aeruginosa - intolerability, toxicity or hypersensitivity to inhaled tobramycin - renal failure, hypoacusis - VEMS ≤ 30% - acute exacerbation needing immediate parenteral antibiotic treatment (primo infection), pregnancy, feeding, against indications in the treatment or medical xplorations - hypersensibility to an aminoside
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E.5 End points |
E.5.1 | Primary end point(s) |
Mesurement of Pseudomonas aeruginosa rate in bronchial secretions (eradication or decrease more than 2 log10 will be considered as significant for the patient).
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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 | No |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | 25 |
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 | 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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |