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. MedDRA version: 9.1 Level: LLT Classification code 10006446 Term: Bronchiectasis NOS
Conditions
Interventions
Product Name: Liposomal Ciprofloxacin Hydrochloride for inhalation
Product Code: None assigned
Pharmaceutical Form: Nebuliser suspension
INN or Proposed INN: Ciprofloxacin Hydrochloride
CAS Number: 8
Sponsors
Aradigm Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: 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).;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. | — |
Countries
United Kingdom
Outcome results
None listed