Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00007335

Trial Description

start of 1:1-Block title

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.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

RESPIRE 2

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007335
  •   2016/03/04
  •   2014/04/04
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2013-004659-19 
  •   NCT02106832  (ClinicalTrials.gov)
  •   15626  (Bayer)
  •   2013-004659-19 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Bronchiectasis
  •   J47 -  Bronchiectasis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Time to first exacerbation; time frame: over 48 weeks after baseline; Description: Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Mean number of exacerbations per patient per 48 weeks; time frame: over 48 weeks after baseline; 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
- 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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Austria
  •   Brazil
  •   Bulgaria
  •   China
  •   Czech Republic
  •   Germany
  •   Hong Kong
  •   Korea, Republic of
  •   Latvia
  •   Lithuania
  •   Netherlands
  •   Poland
  •   Portugal
  •   Romania
  •   Russian Federation
  •   South Africa
  •   Taiwan, Province of China
  •   Thailand
  •   Turkey
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2014/04/30
  •   300
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Bayer
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Novartis
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Bayer
    • Bayer Study Director 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Bayer Clinical Trials Contact 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.