Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis ORBIT-1

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.

Official Title
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An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis Bronchiectasis

Conditions
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Non-Cystic Fibrosis Bronchiectasis

Intervention / Treatment
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* Drug: Ciprofloxacin for Inhalation
* Drug: Ciprofloxacin for Inhalation
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are willing and able to provide written informed consent. Are males or females 18 to 80 year of age, inclusive. Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography (HRCT) for at least 4 years. Confirmation of infection with P. aeruginosa at screening Exclusion Criteria: Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics. 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 drug. Have a diagnosis of cystic fibrosis.. 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 Bronchodilator medications Oral corticosteroid. Have received an investigational drug or device within 28 days prior to Visit 1. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ciprofloxacin for Inhalation 100 mg/day by inhalation | Drug: Ciprofloxacin for Inhalation<br>* 100 mg once daily by inhalation for 28 days<br>|
| Experimental: 2<br>Ciprofloxacin for inhalation 150 mg/day by inhalation | Drug: Ciprofloxacin for Inhalation<br>* 150 mg once daily by inhalation for 28 days<br>|
| Placebo Comparator: Placebo<br>Placebo by inhalation | Drug: Placebo<br>* Placebo once daily by inhalation for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint is defined as the mean change in P. aeruginosa density in sputum (log10) CFU/gram of sputum from Baseline to Day 28. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological efficacy |  | 28 days | 
| Time to, number of, severity of, and time to resolve exacerbations |  | 28 days | 
| Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability |  | 28 days | 
| Quality of life (QOL) |  | 28 days | 
| Safety and tolerability |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pseudomonas aeruginosa, antimicrobial, inhalation, ciprofloxacin, Non-Cystic Fibrosis Bronchiectasis