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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)
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.
Secondary ID [1] 0 0
2013-004659-19
Secondary ID [2] 0 0
15626
Universal Trial Number (UTN)
Trial acronym
RESPIRE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo
Timepoint [1] 0 0
Up to Week 48
Primary outcome [2] 0 0
Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo
Timepoint [2] 0 0
Up to Week 48
Secondary outcome [1] 0 0
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Timepoint [1] 0 0
Up to Week 48
Secondary outcome [2] 0 0
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Timepoint [2] 0 0
Up to Week 48
Secondary outcome [3] 0 0
Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)
Timepoint [3] 0 0
End of treatment (Week 44/46)
Secondary outcome [4] 0 0
Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)
Timepoint [4] 0 0
Baseline and end of treatment (Week 44/46)
Secondary outcome [5] 0 0
Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)
Timepoint [5] 0 0
End of treatment (Week 44/46)
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
Baseline and end of treatment (Week 44/46)
Secondary outcome [7] 0 0
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)
Timepoint [7] 0 0
Baseline and end of treatment (Week 44/46)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/10/2016
Sample size
Target
Accrual to date
Final
521
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
- Kogarah
Recruitment hospital [2] 0 0
- New Lambton Heights
Recruitment hospital [3] 0 0
- Adelaide
Recruitment hospital [4] 0 0
- Parkville
Recruitment hospital [5] 0 0
- Murdoch
Recruitment hospital [6] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
5041 - Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Adelaide
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment postcode(s) [7] 0 0
6009 - Perth
Recruitment outside Australia
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California
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South Carolina
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Texas
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Argentina
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Ciudad Auton. de Buenos Aires
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Argentina
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Mendoza
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Argentina
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Córdoba
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Argentina
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Vicente López
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Austria
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Graz
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Austria
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Salzburg
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Brazil
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Brazil
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Pernambuco
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Brazil
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Rio Grande do Sul
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Brazil
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Sao Paulo
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Brazil
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Bulgaria
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Gabrovo
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Kozloduy
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Lovech
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Ruse
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Sliven
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Sehitkamil

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novartis
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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