E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted)
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006445 |
E.1.2 | Term | Bronchiectasis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006445 |
E.1.2 | Term | Bronchiectasis |
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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 |
The primary objective of this study in patients with non-CF bronchiectasis with positive sputum culture is to determine the effect of ciprofloxacin inhale on bacterial density, measured by decadic logarithm (log10) of reduction in colony forming units (CFUs) per gram sputum. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the emergence of new potential respiratory pathogens, and the emergence of resistance among baseline pathogens in those patients with persistent infection or colonization - To determine the efficacy and safety of ciprofloxacin inhale - To determine plasma and sputum concentrations of ciprofloxacin at predefined time windows at 2 specific visits during treatment from selected patients in selected centers.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Adults at least 18 years of age · Pulmonary stable patients with a proven and documented diagnosis of non-CF idiopathic or post pneumonic bronchiectasis (including patients with primary ciliary dyskenisia) by a CT scan compatible with bronchiectasis at initial diagnosis and > 1 course(s) of systemic antibiotics for exacerbations or ≥ 1 hospitalization for i.v. antibiotic treatment for pulmonary exacerbation during last 12 months. · Stable pulmonary status, as indicated by a forced expired volume in 1 second (FEV1, percent of predicted) of ≥ 35 % and ≤ 80 % · Pre-treatment sputum sample available (patient must be able to produce a sputum sample with a volume ≥ 5 mL) that is positive for at least one of the pre-defined pathogens
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E.4 | Principal exclusion criteria |
·FEV 1 (percent of predicted) < 35% or > 80% (post bronchodilator) · Allergic bronchopulmonary aspergillosis (diagnosed radiologically, serologically or clinically) · Immunodeficiency disease requiring immunoglobulin replacement · Non-tuberculosis mycobacteria infection · Rheumatoid arthritis · Recent significant hemoptysis (≥ 300 cm3 or requiring blood transfusion) in the preceding 4 weeks · Nebulized antibiotics as maintenance therapy within the previous 4 weeks prior to randomization · Antibiotic treatment of an exacerbation or any other infection within previous 4 weeks prior to randomization
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E.5 End points |
E.5.1 | Primary end point(s) |
The change from baseline in total bacterial load in the sputum (specified pathogens only) until the end of treatment (4 weeks). Statistically, the main efficacy analysis will be a two-way analysis of covariance (ANCOVA) with factors treatment group (Cipro Inhale, placebo) and center. The dependent variable will be log10(CFU+1) at the end of the 4 week treatment period; baseline log10(CFU+1) will serve as a covariate. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 16 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | Yes |
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 end of the trial is the last visit of the last patient |
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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 | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |