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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

Study Description
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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.

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

Detailed Description:
Number of participants with Adverse events will be covered in Adverse Events section.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 521 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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.
Actual Study Start Date : April 30, 2014
Actual Primary Completion Date : September 13, 2016
Actual Study Completion Date : October 19, 2016

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Arms and Interventions
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Arm Intervention/treatment
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).
 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.
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).
 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.
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).
 Drug: Placebo
Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off
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).
 Drug: Placebo
Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106832


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02106832    
Other Study ID Numbers: 15626
2013-004659-19 ( EudraCT Number )
First Posted: April 8, 2014    Key Record Dates
Results First Posted: September 1, 2017
Last Update Posted: October 2, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Ciprofloxacin
Dry Powder for Inhalation
Exacerbation
Bronchiectasis
Additional relevant MeSH terms:
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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