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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-Cystic Fibrosis Bronchiectasis
• Intervention / Treatment: Drug: Ciprofloxacin for Inhalation; Drug: Ciprofloxacin for Inhalation; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1L9
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1E4
    • Vancouver, British Columbia, Canada, V5Z 1M9
    • Vancouver, British Columbia, Canada, V5Z 4E1
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
  • Quebec
    • Montreal, Quebec, Canada, H2W 1T8
    • St. Jerome, Quebec, Canada, J7Z 5T3
• Germany
  • Berlin, Germany, 13353
  • Donaustauf, Germany, 93093
  • Heidelberg, Germany, 69126
  • Neuwied, Germany, 56564
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • "Bordesley Green East
  • Glasgow, United Kingdom, G21 3UW
    • "133 Balornock Road
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • Salford, United Kingdom, M6 8HD
    • "Stott Lane
  • Stoke on Trent, United Kingdom, ST4 6QG
    • "Newcastle Road
  • Tyne and Wear, United Kingdom, NE29 8NH
    • "Northumbria Healthcare
  • Britain
    • Belfast, Britain, United Kingdom, BT9 7AB
      • "Ground Floor, Tower Block, Lisburn Road
    • Birmingham, Britain, United Kingdom
      • "1st Floor, Nuffield House, B15 2TH
    • Bradford, Britain, United Kingdom, BD9 6RJ
      • "Duckworth Lane,
    • Manchester, Britain, United Kingdom
      • "Southmoor Road, M23 9LT
  • Freeman Road, High Heaton
    • Newcastle upon Tyne, Freeman Road, High Heaton, United Kingdom, NE7 7DN
  • High Street Lewisham
    • London, High Street Lewisham, United Kingdom, SE13 6LH
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
  • California
    • Los Angeles, California, United States, 90048
    • Sacramento, California, United States, 95819
    • Torrance, California, United States, 90505
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
  • Florida
    • Brandon, Florida, United States, 33511
    • Miami, Florida, United States, 33136
  • Iowa
    • Council Bluffs, Iowa, United States, 51503
  • New Jersey
    • Summit, New Jersey, United States, 07901
  • New York
    • New York, New York, United States, 10016
  • North Carolina
    • Elizabeth City, North Carolina, United States, 27909
  • Ohio
    • Toledo, Ohio, United States, 43614
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
  • Texas
    • McKinney, Texas, United States, 75069

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Ciprofloxacin for Inhalation 100 mg/day by inhalation	Drug: Ciprofloxacin for Inhalation; 100 mg once daily by inhalation for 28 days; Drug: Ciprofloxacin for Inhalation; 150 mg once daily by inhalation for 28 days
Experimental: 2; Ciprofloxacin for inhalation 150 mg/day by inhalation	Drug: Ciprofloxacin for Inhalation; 100 mg once daily by inhalation for 28 days; Drug: Ciprofloxacin for Inhalation; 150 mg once daily by inhalation for 28 days
Placebo Comparator: Placebo; Placebo by inhalation	Drug: Placebo; Placebo once daily by inhalation for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Aradigm Corporation
• Investigators: Study Director: Paul Bruinenberg, MBChB, MBA, Aradigm Corporation

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimate): April 29, 2009

Study Record Updates

• Last Update Posted (Estimate): January 25, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: antimicrobial; inhalation; Pseudomonas aeruginosa; ciprofloxacin; Non-Cystic Fibrosis Bronchiectasis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Bronchial Diseases; Fibrosis; Bronchiectasis; Respiratory Aspiration; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: ARD-3100-0901