None listed
Conditions
Brief summary
This study will compare the safety and efficacy of the mixture formulation consisting of liposomal and free ciprofloxacin for inhalation to placebo for inhalation in patients who have a confirmed diagnosis of non-CF bronchiectasis with a history of chronic Pseudomonas Aeruginosa infections.
Interventions
This is a Phase 2a, international, multicenter, randomized, double-blind, placebo controlled study designed to evaluate safety and efficacy of the mixture formulation consisting of liposomal and free ciprofloxacin for inhalation compared to placebo for inhalation in patients with non CF bronchiectasis with chronic lung infection. Patients will be enrolled in this study for 6 months. This study will consist of a 14 day Screening Phase and a Treatment Phase consisting of three 28 day On treatment
This is a Phase 2a, international, multicenter, randomized, double-blind, placebo controlled study designed to evaluate safety and efficacy of the mixture formulation consisting of liposomal and free ciprofloxacin for inhalation compared to placebo for inhalation in patients with non CF bronchiectasis with chronic lung infection. Patients will be enrolled in this study for 6 months. This study will consist of a 14 day Screening Phase and a Treatment Phase consisting of three 28 day On treatment Periods (Months 1, 3, and 5) and three 28 day Off treatment Periods (Months 2, 4, and 6). Patients will have a one week wash out period after each treatment period. Patients will be randomised to receive one of the following inhaled treatment regimens, which will be administered via nebulizer once daily during the three 28 day On-treatment Periods (Months 1, 3, and 5): Mixture Formulation, which consists of the following: Liposomal Ciprofloxacin and Free Ciprofloxacin Or Placebo.
Sponsors
Aradigm Corporation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Are willing and able to provide written informed consent. 2. Are males or females 18 to 80 year of age, inclusive, who are able to walk. 3. Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography. 4. Have a confirmed history of at least two exacerbations treated with a course of antibiotics within the last 12 months. 5. Have been off any anti-pseudomonal antibiotic for a minimum of 28 days prior to the Screening Visit (Visit 0). 6. Have FEV1 of more than 25% of predicted values at the Screening Visit (Visit 0). 7. Have positive documented Pseudomonas aeruginosa in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to the Screening Visit (Visit 0) and in the sputum/ deep-throat cough swab culture collected at the Screening Visit (Visit 0). 8. Are clinically stable in the opinion of the investigator. 9. Are willing to comply with the requirements for participation in the study. 10. Are willing to use an acceptable method of contraception during the study. 11. Female patients of childbearing potential must provide a negative pregnancy test at the Screening Visit and must use an acceptable method of contraception for at least 3 weeks prior to the first dose of study drugs and for 30 days after the last dose of study drugs. Acceptable methods of contraception for women are orally administered hormonal contraceptives, surgical intervention, intrauterine device (IUD), and sexual abstinence. If a hormonal contraceptive is utilized as the method of contraception, the same method must have been used for at least 3 months prior to Visit 1. To be considered “not of child bearing potential”, female patients must be at least 2 years postmenopausal, or have been irreversibly surgically sterilized by hysterectomy, oophorectomy, or bilateral tubal ligation for at least 3 months prior to the first dose of study drugs. Male patients whose female partners are of child bearing potential (definition as above) must agree to use an acceptable method of birth control (as listed above) for the duration of study treatment and for 30 days after the last dose of study drugs.
Exclusion criteria
1. Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics. 2. Have an exacerbation during the Screening Phase as defined as requiring treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drugs. 3. Have a diagnosis of cystic fibrosis. 4. Have a diagnosis of allergic brochopulmonary aspergillosis. 5. Have received any intravenous, oral, or inhaled anti-pseudomonal antibiotic within 28 days prior to Visit 1. 6. Have used tizanidine within 28 days prior to Visit 1. 7. Have used supplemental oxygen within 28 days prior to Visit 1. 8. Have used any intravenous or intramuscular corticosteroid or have used oral corticosteroid >10 mg/day or >20 mg every other day within 28 days of Visit 1. 9. Have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to Visit 1: Azithromycin Hypertonic saline Mucolytics Bronchodilator medications Oral corticosteroid 10. Have had changes in physiotherapy technique or schedule within 28 days prior to Visit 1. 11. Have a history of solid organ (e.g., lung) transplantation. 12. Have a history of non-tuberculosis mycobacteria requiring treatment within 12 months prior to Visit 1. 13. Have serum creatinine levels greater than 1.5x upper limit of normal (ULN) at the Screening Visit (Visit 0). 14. Have serum transaminase levels >3x ULN at the Screening Visit (Visit 0). 15. Have a febrile illness within 1 week prior to Visit 1. 16. Have had massive hemoptysis (greater than or equal to 300 mL or requiring blood transfusion) within 6 months prior to Visit 1. 17. Have used 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. 18. Have received an investigational drug or device within 28 days prior to Visit 1. 19. Have any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patients’ treatment, assessment, or compliance with the protocol. 20. Have a history or suspicion of unreliability, poor cooperation, or non-compliance with medical treatment. 21. Are unable to use nebulizers. 22. Are unable either to understand the instruction for use of the study drugs or to complete the Quality of life (QoL) questionnaire at Visit 1. 23. Have previously been enrolled in this study. 24. Are pregnant, plan to become pregnant during this study, are nursing mothers or are unwilling to use an acceptable method of contraception for the duration of the study. Patients who meet all inclusion and none of the exclusion criteria and meet the following sputum criteria at screening will be enrolled into the study: Sputum positive for Pseudomonas aeruginosa Sputum Pseudomonas aeruginosa sensitive to ciprofloxacin
Outcome results
None listed