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Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)

NCT01764841 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2018-01-24

Study results available
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Summary

The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

Conditions

Interventions

DRUG

Ciprofloxacin DPI (BAYQ3939)

Participants received 32.5 mg ciprofloxacin hydrated (corresponding to 50 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.

DRUG

Placebo

Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-02
Primary Completion
2016-03-09
Completion
2016-03-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Latvia
  • New Zealand
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01764841 on ClinicalTrials.gov