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Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) (RESPIRE 2)

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02106832
First received: April 4, 2014
Last updated: December 1, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Bronchiectasis
Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time to first exacerbation [ Time Frame: over 48 weeks after baseline ]
    Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics


Secondary Outcome Measures:
  • Mean number of exacerbations per patient per 48 weeks [ Time Frame: over 48 weeks after baseline ]
    Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics

  • 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 ]

Enrollment: 519
Study Start Date: April 2014
Study Completion Date: October 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ciprofloxacin: 28 days on / 28 days off Drug: 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 28 days on / 28 days off Drug: Placebo
Placebo inhaled twice a day intermittently administered for 28 days on / 28 days off
Experimental: Ciprofloxacin: 14 days on / 14 days off Drug: 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 14 days on / 14 days off Drug: Placebo
Placebo inhaled twice a day intermittently administered for 14 days on / 14 days off

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02106832

  Show 207 Study Locations
Sponsors and Collaborators
Bayer
Novartis
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02106832     History of Changes
Other Study ID Numbers: 15626
2013-004659-19 ( EudraCT Number )
Study First Received: April 4, 2014
Last Updated: December 1, 2016

Keywords provided by Bayer:
Ciprofloxacin
Dry Powder for Inhalation
Exacerbation
Bronchiectasis

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 25, 2017