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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00889967
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : January 25, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-Cystic Fibrosis Bronchiectasis Drug: Ciprofloxacin for Inhalation Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

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

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Microbiological efficacy [ Time Frame: 28 days ]
  2. Time to, number of, severity of, and time to resolve exacerbations [ Time Frame: 28 days ]
  3. Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability [ Time Frame: 28 days ]
  4. Quality of life (QOL) [ Time Frame: 28 days ]
  5. Safety and tolerability [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00889967

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Sponsors and Collaborators
Aradigm Corporation
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Study Director: Paul Bruinenberg, MBChB, MBA Aradigm Corporation
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Responsible Party: Aradigm Corporation Identifier: NCT00889967    
Other Study ID Numbers: ARD-3100-0901
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: August 2012
Keywords provided by Aradigm Corporation:
Pseudomonas aeruginosa
Non-Cystic Fibrosis Bronchiectasis
Additional relevant MeSH terms:
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Respiratory Aspiration
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Bronchial Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors