Trial | NCT00889967  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ciprofloxacin ...

  • Study Participants

    95
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.
Study Started
Feb 28
2010
Primary Completion
Apr 30
2011
Study Completion
Jun 30
2011
Last Update
Jan 25
2017
Estimate

Drug Ciprofloxacin for Inhalation

100 mg once daily by inhalation for 28 days

Drug Ciprofloxacin for Inhalation

150 mg once daily by inhalation for 28 days

Drug Placebo

Placebo once daily by inhalation for 28 days

1 Experimental

Ciprofloxacin for Inhalation 100 mg/day by inhalation

2 Experimental

Ciprofloxacin for inhalation 150 mg/day by inhalation

Placebo Placebo Comparator

Placebo by inhalation

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.
No Results Posted