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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02106832
Registration number
NCT02106832
Ethics application status
Date submitted
4/04/2014
Date registered
8/04/2014
Date last updated
2/10/2017
Titles & IDs
Public title
Ciprofloxacin Dry Powder for Inhalation (DPI) 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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2013-004659-19
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Secondary ID [2]
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15626
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Universal Trial Number (UTN)
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Trial acronym
RESPIRE 2
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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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Condition category
Condition code
Respiratory
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0
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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 (BAYQ3939) dry powder for inhalation
Treatment: Drugs - Ciprofloxacin (BAYQ3939) dry powder for inhalation
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
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).
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).
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).
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).
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: Placebo
Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off
Treatment: Drugs: Placebo
Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off
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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 - Cipro 28 vs. Pooled Placebo
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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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Primary outcome [2]
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Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo
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Assessment method [2]
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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 [2]
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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 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
30/04/2014
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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
19/10/2016
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Sample size
Target
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Accrual to date
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Final
521
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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- Kogarah
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- New Lambton Heights
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- Adelaide
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- Parkville
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- Murdoch
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- Perth
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Recruitment postcode(s) [1]
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2217 - Kogarah
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2305 - New Lambton Heights
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Recruitment postcode(s) [3]
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5041 - Adelaide
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Recruitment postcode(s) [4]
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5042 - Adelaide
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Recruitment postcode(s) [5]
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3050 - Parkville
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment postcode(s) [7]
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6009 - Perth
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Recruitment outside Australia
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Ciudad Auton. de Buenos Aires
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Mendoza
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Romania
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Bucharest
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Romania
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Codlea
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Romania
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Constanta
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Romania
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Iasi
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Romania
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Ploiesti
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Romania
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Timisoara
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Russian Federation
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Arkhangelsk
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Russian Federation
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Chelyabinsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Ufa
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Russian Federation
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Voronezh
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Cacak
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Serbia
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Knez Selo
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Serbia
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Kragujevac
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Serbia
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Sombor
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Serbia
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Sremska Kamenica
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Serbia
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Valjevo
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Slovakia
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Bratislava
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Slovakia
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Presov
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South Africa
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Gauteng
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South Africa
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Kwazulu-Natal
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South Africa
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Western Cape
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Taiwan
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Chiayi
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei City,
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Taiwan
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Taichung
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Chiangmai
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Thailand
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Khon Kaen
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Thailand
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NakhonRatchasima
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Thailand
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Phitsanulok
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Thailand
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State/province [141]
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Udonthani
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Turkey
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Ankara
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Country [143]
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Turkey
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Balcali
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Turkey
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Izmir
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Turkey
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Kampus
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Turkey
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Konya
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Turkey
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Maltepe
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Turkey
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Mersin
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Turkey
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Pendik
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Turkey
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Samsun
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Turkey
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Sehitkamil
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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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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
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Novartis
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Address [1]
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0
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Ethics approval
Ethics application status
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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/study/NCT02106832
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Trial related presentations / publications
Aksamit T, De Soyza A, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1):1702053. doi: 10.1183/13993003.02053-2017. Print 2018 Jan. Aksamit T, Bandel TJ, Criollo M, De Soyza A, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis. Contemp Clin Trials. 2017 Jul;58:78-85. doi: 10.1016/j.cct.2017.05.007. Epub 2017 May 8.
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Public notes
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Contacts
Principal investigator
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Bayer Study Director
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Bayer
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02106832
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