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

Bronchiectasis Clinical Trial

— RESPIRE 2  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106832
• Other study ID #: 15626
• Secondary ID: 2013-004659-19
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2014
• Last updated: September 4, 2017
• Start date: April 30, 2014
• Est. completion date: October 19, 2016

Study information

• Verified date: September 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Number of participants with Adverse events will be covered in Adverse Events section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: October 19, 2016
• Est. primary completion date: September 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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)

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• 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.
• 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.
• Placebo
Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off
• Placebo
Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Novartis

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Bulgaria,  China,  Czechia,  Germany,  Hong Kong,  Korea, Republic of,  Latvia,  Lithuania,  Netherlands,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Taiwan,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo	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.	Up to Week 48
Primary	Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo	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.	Up to Week 48
Secondary	Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks	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.	Up to Week 48
Secondary	Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks	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.	Up to Week 48
Secondary	Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)	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.	End of treatment (Week 44/46)
Secondary	Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)	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.	Baseline and end of treatment (Week 44/46)
Secondary	Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)	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.	End of treatment (Week 44/46)
Secondary	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)	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.	Baseline and end of treatment (Week 44/46)
Secondary	Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)	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).	Baseline and end of treatment (Week 44/46)

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