CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 521 enrolled
Drug / intervention
Ciprofloxacin (BAYQ3939) dry powder for inhalation +3 moredrug
Likely dose
Ciprofloxacin (BAYQ3939) dry powder for inhalation 32.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02106832
NCT02106832Phase 3Completed

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.

Bayer·interventional·Posted Apr 8, 2014·Updated Oct 2, 2017

In Brief

A Phase 3 clinical trial evaluating Ciprofloxacin (BAYQ3939) dry powder for inhalation and Placebo for Bronchiectasis. Completed, enrolled 521 participants across 207 sites in 25 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchiectasis
CountriesArgentina, Australia, Austria, Brazil, Bulgaria, China, Czechia, Germany, Hong Kong, Latvia, Lithuania, Netherlands, Philippines, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey (Türkiye), United States
CollaboratorsNovartis

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 8, 2014
Enrollment StartApr 30, 2014
Primary CompletionSep 13, 2016
Study CompletionOct 19, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.2 years ago

Interventions

Ciprofloxacin (BAYQ3939) dry powder for inhalationdrug

Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment.

Ciprofloxacin (BAYQ3939) dry powder for inhalationdrug

Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment.

Placebodrug

Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off

Placebodrug

Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off