Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)

Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID 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. - RESPIRE 1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004208-39-DE

Enrollment

400

Registered

2012-10-23

Start date

2013-01-21

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bronchiectasis MedDRA version: 18.1 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Ciprofloxacin DPI Product Code: BAYq3939 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Ciprofloxacin Current Sponsor code: BAYq3939 Other descriptive name: CI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Age =18 years; ? Proven and documented diagnosis of non-CF idiopathic or post-infectious BE by HRCT scan (conventional high resolution CT is considered the standard) including 2 or more lobes and dilated airways compatible with BE at initial diagnosis ? Positive culture from an adequate sputum sample for Pseudomonas aeruginosa, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Streptococcus pneumoniae, Stenotrophomonas maltophilia or Burkholderia cepacia obtained at screening and with history =2 documented exacerbations in the past 12 months; ? Stable pulmonary status as indicated by FEV1 (percent of predicted) =30% and =65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: ? FEV1 10 mg/day prednisolone equivalent for >14 days within 4 weeks prior to the administration of study drug; ? If participating in or has participated in other investigational interventional studies within the previous 28 days ?Subjects with any other conditions (specifically those which are addressed in the warnings and precautions section of the IB) or clinically relevant laboratory findings that the investigator defines as not appropriate for enrollment of a subject into the study ? Previous assignment to treatment in this study (randomized in Study 15625).

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of the study are: • To evaluate the efficacy of ciprofloxacin DPI administered BID intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study treatment / 14 days off study treatment to prolong the time to first exacerbation requiring an intervention with systemic antibiotics in subjects with non CF BE. •To evaluate the efficacy of ciprofloxacin dry powder for inhalation (DPI) administered 2 times a day (BID) intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study treatment / 14 days off study treatment in reducing the frequency of pulmonary exacerbation requiring an intervention with systemic antibiotics in subjects with non–CF BEwithin 48 weeks after start of treatment;Secondary Objective: The secondary objectives of this study are: •To assess pathogen eradication and acquisition of new pathogenic organisms not present at baseline; •To assess the safety and tolerability of different long term regimen of ciprofloxacin DPI; •To assess the improvement of quality of life by Saint George’s Respiratory Questionnaire (SGRQ); •To assess changes in lung function as measured by change in FEV1.;Primary end point(s): Time to first exacerbation Description: Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics ;Timepoint(s) of evaluation of this end point: over 48 weeks after baseline	—

Measure

Time frame

Main Objective: The primary objectives of the study are: • To evaluate the efficacy of ciprofloxacin DPI administered BID intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study treatment / 14 days off study treatment to prolong the time to first exacerbation requiring an intervention with systemic antibiotics in subjects with non CF BE. •To evaluate the efficacy of ciprofloxacin dry powder for inhalation (DPI) administered 2 times a day (BID) intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study treatment / 14 days off study treatment in reducing the frequency of pulmonary exacerbation requiring an intervention with systemic antibiotics in subjects with non–CF BEwithin 48 weeks after start of treatment;Secondary Objective: The secondary objectives of this study are: •To assess pathogen eradication and acquisition of new pathogenic organisms not present at baseline; •To assess the safety and tolerability of different long term regimen of ciprofloxacin DPI; •To assess the improvement of quality of life by Saint George’s Respiratory Questionnaire (SGRQ); •To assess changes in lung function as measured by change in FEV1.;Primary end point(s): Time to first exacerbation Description: Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics ;Timepoint(s) of evaluation of this end point: over 48 weeks after baseline

—

Secondary

Measure	Time frame
Secondary end point(s): -Changes from baseline in the disease-specific PRO score QOL-B respiratory symptom domain; -Number/time to exacerbation using different definitions of exacerbation; -Changes from baseline in FVC and FEV1 / FVC (post- bronchodilator spirometry); -Changes from baseline in inflammatory markers (hsCRP, PMN count); -Exploratory endpoint (at participating centers): Changes from baseline in sputum inflammatory markers IL 8 and MPO; -Shift in minimal inhibitory concentration (MIC) over time; -Number of participants with adverse events as a measure of safety and tolerability ;Timepoint(s) of evaluation of this end point: respectively: - over 48 weeks after baseline - baseline and 48 weeks - baseline and 48 weeks - baseline and 48 weeks - baseline and 48 weeks - baseline and 48 weeks - over 58 weeks after screening	—

Measure

Time frame

Secondary end point(s): -Changes from baseline in the disease-specific PRO score QOL-B respiratory symptom domain; -Number/time to exacerbation using different definitions of exacerbation; -Changes from baseline in FVC and FEV1 / FVC (post- bronchodilator spirometry); -Changes from baseline in inflammatory markers (hsCRP, PMN count); -Exploratory endpoint (at participating centers): Changes from baseline in sputum inflammatory markers IL 8 and MPO; -Shift in minimal inhibitory concentration (MIC) over time; -Number of participants with adverse events as a measure of safety and tolerability ;Timepoint(s) of evaluation of this end point: respectively: - over 48 weeks after baseline - baseline and 48 weeks - baseline and 48 weeks - baseline and 48 weeks - baseline and 48 weeks - baseline and 48 weeks - over 58 weeks after screening

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Countries

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

Contacts

Public ContactClinical Trials Contact

Bayer HealthCare AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026