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

Phase 2

Completed

• Conditions: Non-Cystic Fibrosis Bronchiectasis
• Interventions: Drug: Ciprofloxacin for Inhalation; Drug: Placebo

• Registration Number: NCT00889967
• Lead Sponsor: Aradigm Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Study Start: 2010-02
• Primary Completion: 2011-04
• Study Completion: 2011-06
• Status Verified: 2012-08
• Disposition First Submitted: 2017-01-23
• Disposition First Submitted QC: 2017-01-23
• Last Update Submitted: 2017-01-23
• Disposition First Posted: 2017-01-25
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1. Are willing and able to provide written informed consent.
2. Are males or females 18 to 80 year of age, inclusive.
3. Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography (HRCT) for at least 4 years.
4. Confirmation of infection with P. aeruginosa at screening

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 drug.

3. Have a diagnosis of cystic fibrosis..

4. 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.

5. Have received an investigational drug or device within 28 days prior to Visit 1.

6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ciprofloxacin for Inhalation	Ciprofloxacin for Inhalation 100 mg/day by inhalation
2	Ciprofloxacin for Inhalation	Ciprofloxacin for inhalation 150 mg/day by inhalation
Placebo	Placebo	Placebo by inhalation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety and tolerability	28 days
Quality of life (QOL)	28 days
Time to, number of, severity of, and time to resolve exacerbations	28 days
Microbiological efficacy	28 days
Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability	28 days

Trial Locations

Locations (10)

"1st Floor, Nuffield House, B15 2TH; 🇬🇧 Birmingham, Britain, United Kingdom

"Ground Floor, Tower Block, Lisburn Road; 🇬🇧 Belfast, Britain, United Kingdom

"Stott Lane; 🇬🇧 Salford, United Kingdom

"Duckworth Lane,; 🇬🇧 Bradford, Britain, United Kingdom

"Bordesley Green East; 🇬🇧 Birmingham, United Kingdom

"Newcastle Road; 🇬🇧 Stoke on Trent, United Kingdom

"133 Balornock Road; 🇬🇧 Glasgow, United Kingdom

"Northumbria Healthcare; 🇬🇧 Tyne and Wear, United Kingdom

"Southmoor Road, M23 9LT; 🇬🇧 Manchester, Britain, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, United Kingdom