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

Sponsor:	Aradigm Corporation
Information provided by:	Aradigm Corporation
ClinicalTrials.gov Identifier:	NCT00889967

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 II

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:

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

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 ]

Estimated Enrollment:	108
Study Start Date:	February 2010

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:

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.

Contacts and Locations

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:	Paul R. Bruinenberg, MBChB, MBA/ Medical Director, Aradigm Corporation
ClinicalTrials.gov Identifier:	NCT00889967 History of Changes
Other Study ID Numbers:	ARD-3100-0901
Study First Received:	April 27, 2009
Last Updated:	March 21, 2011
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:

Respiratory Aspiration
Bronchiectasis
Fibrosis
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases

Pathologic Processes
Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012