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Completed

NCT Number: NCT00889967

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

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.

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Key information

Conditions

Non-cystic Fibrosis Bronchiectasis Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pseudomonas Infections Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ciprofloxacin for Inhalation

Drug

100 mg once daily by inhalation for 28 days

Placebo

Drug

Placebo once daily by inhalation for 28 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aradigm Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 29, 2009
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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