Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) (RESPIRE 1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bayer
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01764841
First received: January 8, 2013
Last updated: October 9, 2014
Last verified: October 2014
  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 DPI (BAYQ3939)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Changes of Saint George's Respiratory Questionnaire score from baseline to 48 weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
  • New pathogens at 48 weeks, not present at baseline [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
  • Changes of Forced expiratory volume in 1 second from baseline to 48 weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
  • Number of participants with Adverse events as a measure of safety and tolerability [ Time Frame: over 58 weeks after screening ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: May 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ciprofloxacin DPI 28 days cycle
Inhalation of 32.5 mg Ciprofloxacin DPI inhaled twice a day intermittently administered for 28 days on / 28 days off
Drug: Ciprofloxacin DPI (BAYQ3939)
Placebo Comparator: Placebo 28 days cycle
Inhalation of Placebo inhaled twice a day intermittently administered for 28 days on / 28 days off
Drug: Placebo
Experimental: Ciprofloxacin DPI 14 days cycle
Inhalation of 32.5 mg Ciprofloxacin DPI inhaled twice a day intermittently administered for 14 days on / 14 days off
Drug: Ciprofloxacin DPI (BAYQ3939)
Placebo Comparator: Placebo 14 days cycle
Inhalation of Placebo inhaled twice a day intermittently administered for 14 days on / 14 days off
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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: NCT01764841

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

  Show 144 Study Locations
Sponsors and Collaborators
Bayer
Novartis
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01764841     History of Changes
Other Study ID Numbers: 15625, 2011-004208-39
Study First Received: January 8, 2013
Last Updated: October 9, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Denmark: Danish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
New Zealand: Medsafe
Japan: Ministry of Health, Labor and Welfare
Israel: Israeli Health Ministry Pharmaceutical Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Italy: The Italian Medicines Agency

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
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014