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

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ClinicalTrials.gov Identifier: NCT02106832
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : September 1, 2017
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE April 4, 2014
First Posted Date  ICMJE April 8, 2014
Results First Submitted Date  ICMJE August 2, 2017
Results First Posted Date  ICMJE September 1, 2017
Last Update Posted Date October 2, 2017
Actual Study Start Date  ICMJE April 30, 2014
Actual Primary Completion Date September 13, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
  • Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo [ Time Frame: Up to Week 48 ]
    Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
  • Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo [ Time Frame: Up to Week 48 ]
    Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
Time to first exacerbation [ Time Frame: over 48 weeks after baseline ]
Description: Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics
Change History Complete list of historical versions of study NCT02106832 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
  • Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks [ Time Frame: Up to Week 48 ]
    For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms over 48 weeks.
  • Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks [ Time Frame: Up to Week 48 ]
    For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.
  • Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46) [ Time Frame: End of treatment (Week 44/46) ]
    Pathogen eradication was defined as a negative culture result for all pre-specified pathogens at end of treatment (week 44 or 46 depending on treatment regimen) that were present in the participant at baseline. There was no imputation for participants who discontinued the study prematurely.
  • Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46) [ Time Frame: Baseline and end of treatment (Week 44/46) ]
    The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.
  • Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46) [ Time Frame: End of treatment (Week 44/46) ]
    New pathogens were any of the pre-specified organisms not cultured before start of study medication. There was no imputation for participants who discontinued the study prematurely.
  • Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46) [ Time Frame: Baseline and end of treatment (Week 44/46) ]
    The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.
  • Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46) [ Time Frame: Baseline and end of treatment (Week 44/46) ]
    FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Number of participants with Adverse events will be covered in Adverse Events section.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bronchiectasis
Intervention  ICMJE
  • Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation
    Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment.
  • Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation
    Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment.
  • Drug: Placebo
    Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off
  • Drug: Placebo
    Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off
Study Arms  ICMJE
  • Experimental: Ciprofloxacin DPI 28 Days on/off (Cipro 28)
    Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
    Intervention: Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation
  • Experimental: Ciprofloxacin DPI 14 Days on/off (Cipro 14)
    Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
    Intervention: Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation
  • Placebo Comparator: Placebo 28 Days on/off (Placebo 28)
    Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo 14 Days on/off (Placebo 14)
    Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2017)
521
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2014)
300
Actual Study Completion Date  ICMJE October 19, 2016
Actual Primary Completion Date September 13, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Brazil,   Bulgaria,   China,   Czechia,   Germany,   Hong Kong,   Korea, Republic of,   Latvia,   Lithuania,   Netherlands,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Taiwan,   Thailand,   Turkey,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02106832
Other Study ID Numbers  ICMJE 15626
2013-004659-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Novartis
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP