E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bronchiectasis is respiratory disease with damaged airways. Such patients have frequent bacterial chest infections. The aim of our study is to assess whether nebulised gentamicin 80mg twice daily will reduce the bacteria in the airways and make patients feel better. |
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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 aim of our study is to assess whether nebulised gentamicin 80mg twice daily will reduce the bacteria in the airways, limit airways and systemic inflammation, resulting in improved health related quality of life.
primary endpoint 1] quantitative sputum microbiology assessing both microbial clearance and change in microbial load
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E.2.2 | Secondary objectives of the trial |
The effect of nebulised gentamicin over 1 year on the following: secondary endpoints 1] airways inflammation 2] systemic inflammatory markers 3] pulmonary physiology 4] Borg breathlessness score and St George`s Respiratory Questionnaire 5] 24 hour sputum volume 6] Use of health care resources (GP visits, A+E attendances and in-patient stay)
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Inclusion criteria Bronchiectasis confirmed by high resolution computed tomography of the chest. Clinically stable over the past 4 weeks Patients between the age of 18-85 years of age Chronic sputum production more than 5mls for the majority of days in 3 months before enrolment Patients able to tolerate a nebulised gentamicin challenge without side effects or bronchoconstriction (see below) Patients with an FEV1 more than 35% predicted Smoking <20 pack year history and ex-smokers for more than 1 year
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E.4 | Principal exclusion criteria |
Exclusion Criteria Patients with asthma or allergic bronchopulmonary aspergillosis Patients with COPD or active tuberculosis Patients with cystic fibrosis Unstable angina or uncontrolled congestive cardiac failure Patients with ongoing malignancy Patients with pregnancy or breast feeding Patients unable to tolerate the nebulised gentamicin due to bronchospasm, fall in FEV1 >15% and >200mls despite the addition of nebulised Salbutamol 2.5mg pre nebulised gentamicin, or drug rash Patients with an FEV1 less than 35% predicted Patients with chronic renal failure with a creatinine clearance less than 30mls/minute Patients with vestibular instability Patients with previous side effects with aminoglycosides Serum trough gentamicin levels trough > 1mg/L at any time point during the study Patients chronically colonised with Pseudomonas aeruginosa that are resistant in vitro to nebulised gentamicin
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E.5 End points |
E.5.1 | Primary end point(s) |
primary endpoint 1] quantitative sputum microbiology assessing both microbial clearance and change in microbial load
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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 | No |
E.6.5 | Efficacy | No |
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 | 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
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) | 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
| 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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The trial will bive nebulised gentamicin (80mg twice daily) or nebulised (0.9% saline) twice daily for 1 year.
The end of the trial will be at final assessment (3 months) after last dose of IMP i.e. at 15 months. |
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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 | 15 |
E.8.9.1 | In the Member State concerned days | |