Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01764841
• Date of registration: 08/01/2013
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) RESPIRE 1
• 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.
• Date of first enrolment: May 2, 2013
• Target sample size: 416
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01764841
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Denmark, France, Germany, Israel, Italy, Japan, Latvia, New Zealand, Slovakia, Spain, United Kingdom, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bronchiectasis

Intervention(s)

Drug: Ciprofloxacin DPI (BAYQ3939)

Drug: Placebo

Primary Outcome(s)

Time to First Exacerbation Event Within 48 Weeks [Time Frame: Up to Week 48]

Secondary Outcome(s)

Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks [Time Frame: Up to Week 48]

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)]

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)]

Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks [Time Frame: Up to Week 48]

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)]

Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46) [Time Frame: End of treatment (Week 44/46)]

Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46) [Time Frame: End of treatment (Week 44/46)]

Secondary ID(s)

2011-004208-39

15625

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis

Results

• Results available: Yes
• Date Posted: 24/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01764841