E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To evaluate the safety, tolerability, and effect on sputum P. aeruginosa density of two dose levels of liposomal ciprofloxacin hydrochloride for inhalation in adult subjects with non-CF bronchiectasis. |
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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 | 10006446 |
E.1.2 | Term | Bronchiectasis NOS |
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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 objectives of this study are to evaluate the safety, tolerability, and effect on sputum Pseudomonas aeruginosa density of two dose levels of liposomal ciprofloxacin hydrochloride for inhalation in adult subjects with non-CF bronchiectasis.The primary study endpoint supporting this objective will be the mean change in log10 CFU of P. aeruginosa /gram sputum from Baseline to End-of-treatment (28 consecutive days of dosing). |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Male and female patients age 18 - 80 years, inclusive •Off any antipseudomonal antibiotic for a minimum of 14-days prior to screening visit •Confirmed diagnosis of non-CF bronchiectasis per HRCT •FEV1 at screening >/=25% •Positive P. aeruginosa in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit. •Sputum P. aeruginosa density ≥ 6 log10 CFU/gram after at least 14-days off anti-pseudomonal antibiotics •Sputum P. aeruginosa is sensitive to ciprofloxacin •Clinically stable in the opinion of the investigator •Female subjects of child-bearing potential must be willing to undergo a pregnancy test and agree to use acceptable birth control at least 3 weeks prior to and 3 weeks after the study. To be considered “not of child-bearing potential”, female subjects must be at least 2 years postmenopausal, or have been irreversibly surgically sterilized (by hysterectomy, oophorectomy, or bilateral tubal ligation). Acceptable methods of birth control for women are orally administered hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence. •Provide written informed consent to participate in the study and be willing to comply with all study procedures
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E.4 | Principal exclusion criteria |
•Known or suspected local or systemic hypersensitivity to quinolone antibiotics •History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B. cepacia), within 2 years prior to screening and/or sputum culture yielding B. cepacia at the Screening visit •Sputum P. aeruginosa resistant to ciprofloxacin •Hemoptysis exceeding 50 mL of blood from the respiratory tract at any time within 30 days prior to study drug administration •Females who are pregnant (positive pregnancy test), lactating, or are planning to become pregnant during the study •Use of any anti-pseudomonal antibiotics (or other antibiotics) within 14 days of study drug administration •Participation in a clinical trial or receipt of an experimental therapy within 30 days prior to study dosing •Initiation of treatment with chronic macrolide therapy, or inhaled corticosteroids within 30 days prior to study drug administration (patients may be taking these therapies at the time of enrollment, but they must have initiated treatment more than 30 days prior to study drug administration) •Patients having an exacerbation during the screening process as defined as a requirement of inhaled, oral, or intravenous antibiotics prior to the first study dose will be excluded •Use of any over-the-counter product, herbal product, diet aid, hormone supplement, etc., within 7 days prior to dosing unless approved by both the Principal Investigator and the Sponsor •Patients having one or more of the concomitant illnesses described in detail in Section 8.7.1 of the protocol •Patients with clinically significant out of range laboratory values as stated in Section 8.6 of the protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary study endpoint supporting this objective will be the mean change in log10 CFU of P. aeruginosa /gram sputum from Baseline to End-of-treatment (28 consecutive days of dosing). The primary statistical analysis will consist of a paired test of this endpoint. In addition, an analysis of variance for comparing the mean change from baseline to end-of-treatment between the two dose levels will be done. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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) | 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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Liposomal Ciprofloxacin Hydrochloride for inhalation (low/high dose) |
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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 | 8 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |