Clinical trial NCT00889967: Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Cystic Fibrosis Bronchiectasis
Keywords: Pseudomonas aeruginosa
antimicrobial
inhalation
ciprofloxacin
Non-Cystic Fibrosis Bronchiectasis
Lead sponsor: Aradigm Corporation
Sponsor class: INDUSTRY
First posted: 2009-04-29
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 28 days
Secondary outcomes:
measure: Microbiological efficacy
timeFrame: 28 days
measure: Time to, number of, severity of, and time to resolve exacerbations
timeFrame: 28 days
measure: Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability
timeFrame: 28 days
measure: Quality of life (QOL)
timeFrame: 28 days
measure: Safety and tolerability
timeFrame: 28 days
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Torrance
country: United States
state: California
city: Waterbury
country: United States
state: Connecticut
city: Brandon
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Council Bluffs
country: United States
state: Iowa
city: Summit
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Elizabeth City
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: McKinney
country: United States
state: Texas
city: Calgary
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: St. Jerome
country: Canada
state: Quebec
city: Berlin
country: Germany
city: Donaustauf
country: Germany
city: Heidelberg
country: Germany
city: Neuwied
country: Germany
city: Belfast
country: United Kingdom
facility: "Ground Floor, Tower Block, Lisburn Road
state: Britain
city: Birmingham
country: United Kingdom
facility: "1st Floor, Nuffield House, B15 2TH
state: Britain
city: Bradford
country: United Kingdom
facility: "Duckworth Lane,
state: Britain
city: Manchester
country: United Kingdom
facility: "Southmoor Road, M23 9LT
state: Britain
city: Newcastle upon Tyne
country: United Kingdom
state: Freeman Road, High Heaton
city: London
country: United Kingdom
state: High Street Lewisham
city: Birmingham
country: United Kingdom
facility: "Bordesley Green East
city: Glasgow
country: United Kingdom
facility: "133 Balornock Road
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Salford
country: United Kingdom
facility: "Stott Lane
city: Stoke on Trent
country: United Kingdom
facility: "Newcastle Road
city: Tyne and Wear
country: United Kingdom
facility: "Northumbria Healthcare
Study officials:
affiliation: Aradigm Corporation
name: Paul Bruinenberg, MBChB, MBA
role: STUDY_DIRECTOR
References: