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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01764841
Registration number
NCT01764841
Ethics application status
Date submitted
8/01/2013
Date registered
10/01/2013
Date last updated
24/01/2018
Titles & IDs
Public title
Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
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Scientific 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.
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Secondary ID [1]
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2011-004208-39
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Secondary ID [2]
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15625
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Universal Trial Number (UTN)
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Trial acronym
RESPIRE 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis
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0
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Condition category
Condition code
Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ciprofloxacin DPI (BAYQ3939)
Treatment: Drugs - Placebo
Experimental: Ciprofloxacin DPI 28 Days on/off (Cipro 28) - Participants 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).
Experimental: Ciprofloxacin DPI 14 Days on/off (Cipro 14) - Participants 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).
Placebo Comparator: Placebo 28 Days on/off (Placebo 28) - Participants 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).
Placebo Comparator: Placebo 14 Days on/off (Placebo 14) - Participants 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).
Treatment: Drugs: Ciprofloxacin DPI (BAYQ3939)
Participants received 32.5 mg ciprofloxacin hydrated (corresponding to 50 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.
Treatment: Drugs: Placebo
Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to First Exacerbation Event Within 48 Weeks
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Assessment method [1]
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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.
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Timepoint [1]
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Up to Week 48
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Secondary outcome [1]
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Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
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Assessment method [1]
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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.
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Timepoint [1]
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Up to Week 48
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Secondary outcome [2]
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Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
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Assessment method [2]
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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.
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Timepoint [2]
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Up to Week 48
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Secondary outcome [3]
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Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)
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Assessment method [3]
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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.
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Timepoint [3]
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End of treatment (Week 44/46)
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Secondary outcome [4]
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Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and end of treatment (Week 44/46)
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Secondary outcome [5]
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Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)
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Assessment method [5]
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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.
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Timepoint [5]
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End of treatment (Week 44/46)
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Secondary outcome [6]
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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)
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline and end of treatment (Week 44/46)
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Secondary outcome [7]
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Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)
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Assessment method [7]
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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).
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Timepoint [7]
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Baseline and end of treatment (Week 44/46)
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Eligibility
Key inclusion criteria
- Patients with a proven and documented diagnosis of non Cystic Fibrosis (CF) idiopathic
or post infectious bronchiectasis
- Stable pulmonary status and stable regimen of standard treatment at least for the past
4 weeks
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/05/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/03/2016
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Sample size
Target
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Accrual to date
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Final
416
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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- Woolloongabba
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- Adelaide
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- Woodville
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- Parkville
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- Prahran
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- Murdoch
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- Box Hill
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- Cairns
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- Frankston
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- Kogarah
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- Toorak Gardens
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4102 - Woolloongabba
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5000 - Adelaide
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5041 - Adelaide
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5011 - Woodville
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3050 - Parkville
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3181 - Prahran
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6150 - Murdoch
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3128 - Box Hill
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4870 - Cairns
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3199 - Frankston
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2217 - Kogarah
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Recruitment postcode(s) [12]
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5065 - Toorak Gardens
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Recruitment outside Australia
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Novartis
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01764841
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Contacts
Principal investigator
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Bayer Study Director
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Bayer
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01764841
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