An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Mixture Formulation Consisting of Liposomal and Free Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non-Cystic Fibrosis Bronchiectasis with Chronic Lung Infections.

Phase 2

Recruiting

• Conditions: on cystic fibrosis (CF) bronchiectasis; Non cystic fibrosis (CF) bronchiectasis; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12609000578202
• Lead Sponsor: Aradigm Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study will be to determine whether the microbiological efficacy of the mixture formulation consisting of Ciprofloxacin for Inhalation (CFI) and Free ciprofloxacin for Inhalation (FCI) is superior to placebo for inhalation in the treatment of patients with non Cystic fibrosis (CF) bronchiectasis by evaluating changes in Pseudomonas aeruginosa log10 Colony Forming Units (CFU)/gram of sputum from Baseline to Day 28.[The primary endpoint of this study will evaluate microbiological efficacy from Baseline to Day 28 on the following: Mean change in Pseudomonas aeruginosa density in sputum (log10) Colony Forming Units (CFU)/gram of sputum from Baseline to Day 28.]