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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02106832
First received: April 4, 2014
Last updated: August 25, 2014
Last verified: August 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: administered for 28 days on / 28 days off
Drug: Placebo: administered for 28 days on / 28 days off
Drug: Ciprofloxacin: administered for 14 days on / 14 days off
Drug: Placebo: administered for 14 days on / 14 days off
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 ]
    Description: 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 ]
    Description: 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 ]
  • Quality of Life: Changes of Saint George's Respiratory [ 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 [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
  • Number of participants with Adverse events as a measure of [ Time Frame: up to 58 weeks after screening ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: April 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ciprofloxacin: 28 days on / 28 days off Drug: Ciprofloxacin: administered for 28 days on / 28 days off
Inhalation of 32.5 mg Ciprofloxacin DPI inhaled twice a day intermittently administered for 28 days on / 28 days off
Placebo Comparator: Placebo 28 days on / 28 days off Drug: Placebo: administered for 28 days on / 28 days off
Inhalation of Placebo inhaled twice a day intermittently administered for 28 days on / 28 days off
Experimental: Ciprofloxacin: 14 days on / 14 days off Drug: Ciprofloxacin: administered for 14 days on / 14 days off
Inhalation of 32.5 mg Ciprofloxacin DPI inhaled twice a day intermittently administered for 14 days on / 14 days off
Placebo Comparator: Placebo 14 days on / 14 days off Drug: Placebo: administered for 14 days on / 14 days off
IInhalation of Placebo inhaled twice a day intermittently administered for 14 days on / 14 days off

  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: NCT02106832

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

  Show 100 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: NCT02106832     History of Changes
Other Study ID Numbers: 15626, 2013-004659-19
Study First Received: April 4, 2014
Last Updated: August 25, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos
Australia: Department of Health and Ageing,
Austria: Austrian Medicines and Medical Devices Agency
Brazil: Associação Fundo de Incentivo à Pesquisa
Bulgaria: Ministry of Health
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Korea: Ministry of Food and Drug Safety
Lithuania: State Medicine Control Agency
Netherlands: Medicines Evaluation Board (MEB)
Poland: National Institute of Medicines
Portugal: INFARMED, National Authority of Medicines and Health Products
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Taiwan: Center for Drug Evaluation
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Bronchiectasis
Fibrosis
Bronchial Diseases
Respiratory Tract Diseases
Pathologic Processes
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 August 26, 2014