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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aradigm Corporation
ClinicalTrials.gov Identifier:
NCT00889967
First received: April 27, 2009
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Non-Cystic Fibrosis Bronchiectasis
Drug: Ciprofloxacin for Inhalation
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Aradigm Corporation:

Primary Outcome Measures:
  • 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. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Microbiological efficacy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Time to, number of, severity of, and time to resolve exacerbations [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Quality of life (QOL) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Safety and tolerability [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 95
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ciprofloxacin for Inhalation 100 mg/day by inhalation
Drug: Ciprofloxacin for Inhalation
100 mg once daily by inhalation for 28 days
Experimental: 2
Ciprofloxacin for inhalation 150 mg/day by inhalation
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889967

  Show 37 Study Locations
Sponsors and Collaborators
Aradigm Corporation
Investigators
Study Director: Paul Bruinenberg, MBChB, MBA Aradigm Corporation
  More Information

No publications provided

Responsible Party: Aradigm Corporation
ClinicalTrials.gov Identifier: NCT00889967     History of Changes
Other Study ID Numbers: ARD-3100-0901
Study First Received: April 27, 2009
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Aradigm Corporation:
Pseudomonas aeruginosa
antimicrobial
inhalation
ciprofloxacin
Non-Cystic Fibrosis Bronchiectasis

Additional relevant MeSH terms:
Fibrosis
Respiratory Aspiration
Bronchiectasis
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Bronchial Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014