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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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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
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.
Trial website
https://clinicaltrials.gov/study/NCT02106832
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02106832