Overview

This trial has been completed.

Condition bronchiectasis
Treatments ciprofloxacin (bayq3939) dry powder for inhalation, placebo
Phase phase 3
Sponsor Bayer
Collaborator Novartis
Start date April 2014
End date September 2016
Trial size 519 participants
Trial identifier NCT02106832, 15626, 2013-004659-19

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ciprofloxacin (bayq3939) dry powder for inhalation
Ciprofloxacin DPI 32.5mg inhaled twice daily in cycles of 28 days on- and 28 days off-drug
(Placebo Comparator)
placebo
Placebo inhaled twice a day intermittently administered for 28 days on / 28 days off
(Experimental)
ciprofloxacin (bayq3939) dry powder for inhalation
Ciprofloxacin DPI 32.5mg inhaled twice daily in cycles of 14 days on- and 14 days off-drug
(Placebo Comparator)
placebo
Placebo inhaled twice a day intermittently administered for 14 days on / 14 days off

Primary Outcomes

Measure
Time to first exacerbation
time frame: over 48 weeks after baseline

Secondary Outcomes

Measure
Mean number of exacerbations per patient per 48 weeks
time frame: over 48 weeks after baseline
Pathogens present at baseline and eradicated at 48 weeks
time frame: Baseline and 48 weeks
Quality of Life: Changes of Saint George's Respiratory
time frame: Baseline and 48 weeks
New pathogens at 48 weeks, not present at baseline
time frame: Baseline and 48 weeks
Changes of Forced Expiratory Volume in 1 second from baseline
time frame: Baseline and 48 weeks
Number of participants with Adverse events as a measure of
time frame: up to 58 weeks after screening

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with a proven and documented diagnosis of non CF idiopathic or post infectious bronchiectasis - Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks Exclusion Criteria: - Forced expiratory volume in 1 second (FEV1) <30% or >90% predicted - Active allergic bronchopulmonary aspergillosis - Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis - Primary diagnosis of Chronic obstructive pulmonary disease (COPD)

Additional Information

Official title Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Bayer.