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

Phase 3

Completed

• Conditions: Bronchiectasis
• Interventions: Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation; Drug: Placebo

• Registration Number: NCT02106832
• Lead Sponsor: Bayer

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Study Start: 2014-04-30
• Primary Completion: 2016-09-13
• Study Completion: 2016-10-19
• Results First Submitted: 2017-08-02
• Results First Submitted QC: 2017-08-02
• Status Verified: 2017-09
• Results First Posted: 2017-09-01
• Last Update Submitted: 2017-09-04
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 521

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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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciprofloxacin DPI 28 Days on/off (Cipro 28)	Ciprofloxacin (BAYQ3939) dry powder for inhalation	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).
Ciprofloxacin DPI 14 Days on/off (Cipro 14)	Ciprofloxacin (BAYQ3939) dry powder for inhalation	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 28 Days on/off (Placebo 28)	Placebo	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 14 Days on/off (Placebo 14)	Placebo	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).

Primary Outcome Measures

Name	Time	Method
Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo	Up to Week 48	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.
Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo	Up to Week 48	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks	Up to Week 48	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.
Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)	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.
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks	Up to Week 48	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.
Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)	Baseline and 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.
Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)	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.
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)	Baseline and 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.
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)	Baseline and 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).