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Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) (RESPIRE 2)

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ClinicalTrials.gov Identifier: NCT02106832
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : September 1, 2017
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bronchiectasis
Interventions Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation
Drug: Placebo
Enrollment 521
Recruitment Details Study was conducted at 164 study centers in 25 countries between 30 April 2014 (first subject first visit) and 19 October 2016 (last subject last visit).
Pre-assignment Details A total of 1123 subjects were screened and 521 subjects were randomized. The randomized subjects were allocated to treatment groups, and 2 subjects in the Cipro 14 group did not receive study medication.
Arm/Group Title Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Placebo 28 Days on/Off (Placebo 28) Placebo 14 Days on/Off (Placebo 14)
Hide Arm/Group Description 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). 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). 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). 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).
Period Title: Overall Study
Started 171 176 86 88
Participants Received Treatment 171 174 86 88
Completed 148 151 70 73
Not Completed 23 25 16 15
Reason Not Completed
Adverse Event             1             2             3             0
Death             4             4             1             4
Deterioration of general conditions             0             0             1             0
Lost to Follow-up             0             1             1             3
Physician Decision             1             0             0             0
Protocol Violation             0             0             0             1
Withdrawal by Subject             17             17             10             7
Technical problems             0             1             0             0
Arm/Group Title Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Placebo 28 Days on/Off (Placebo 28) Placebo 14 Days on/Off (Placebo 14) Total
Hide Arm/Group Description 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). 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). 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). 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). Total of all reporting groups
Overall Number of Baseline Participants 171 176 86 88 521
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 171 participants 176 participants 86 participants 88 participants 521 participants
59.3  (14.2) 60.4  (13.7) 60.6  (13.7) 60.4  (15.0) 60.1  (14.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 171 participants 176 participants 86 participants 88 participants 521 participants
Female
92
  53.8%
96
  54.5%
52
  60.5%
62
  70.5%
302
  58.0%
Male
79
  46.2%
80
  45.5%
34
  39.5%
26
  29.5%
219
  42.0%
Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 171 participants 176 participants 86 participants 88 participants 521 participants
60.75  (20.61) 61.26  (19.54) 58.56  (19.17) 63.47  (19.48) 61.00  (19.82)
[1]
Measure Description: 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 baseline measure, the symptoms component score was reported.
Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 171 participants 176 participants 86 participants 88 participants 521 participants
50.14  (19.07) 52.17  (18.49) 53.95  (16.00) 48.67  (17.72) 51.22  (18.16)
[1]
Measure Description: 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 baseline measure, the respiratory symptoms domain score was reported.
Forced Expiratory Volume in One Second (FEV1)   [1] 
Mean (Standard Deviation)
Unit of measure:  Liter
Number Analyzed 171 participants 176 participants 86 participants 88 participants 521 participants
1.569  (0.602) 1.519  (0.617) 1.560  (0.692) 1.477  (0.558) 1.535  (0.615)
[1]
Measure Description: FEV1 was 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).
1.Primary Outcome
Title Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo
Hide Description 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 Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included participants who were randomized.
Arm/Group Title Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Pooled Placebo
Hide Arm/Group Description:
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).
Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
Overall Number of Participants Analyzed 171 174
Median (99.9% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(211 to NA)
[1]
Value cannot be estimated due to censored data.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ciprofloxacin DPI 28 Days on/Off (Cipro 28), Pooled Placebo
Comments The hazard ratio for time to first exacerbation event within 48 weeks and 99.9% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0511
Comments [Not Specified]
Method Wald-type test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.7062
Confidence Interval (2-Sided) 99.9%
0.3928 to 1.2698
Estimation Comments [Not Specified]
2.Primary Outcome
Title Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo
Hide Description 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 Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included participants who were randomized.
Arm/Group Title Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Pooled Placebo
Hide Arm/Group Description:
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).
Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
Overall Number of Participants Analyzed 176 174
Median (95.1% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(278 to NA)
[1]
Value cannot be estimated due to censored data.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ciprofloxacin DPI 14 Days on/Off (Cipro 14), Pooled Placebo
Comments The hazard ratio for time to first exacerbation event within 48 weeks and 95.1% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3965
Comments [Not Specified]
Method Wald-type test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.8662
Confidence Interval (2-Sided) 95.1%
0.6206 to 1.2090
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Hide Description 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.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included participants who were randomized.
Arm/Group Title Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Pooled Placebo
Hide Arm/Group Description:
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).
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).
Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
Overall Number of Participants Analyzed 171 176 174
Measure Type: Count of Participants
Unit of Measure: Participants
Number of exacerbations: 0 115 108 101
Number of exacerbations: 1 46 40 41
Number of exacerbations: 2 8 23 19
Number of exacerbations: 3 2 4 10
Number of exacerbations: 4 0 1 2
Number of exacerbations: 5 0 0 1
4.Secondary Outcome
Title Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Hide Description 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.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included participants who were randomized.
Arm/Group Title Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Pooled Placebo
Hide Arm/Group Description:
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).
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).
Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
Overall Number of Participants Analyzed 171 176 174
Measure Type: Count of Participants
Unit of Measure: Participants
Number of exacerbations: 0 102 96 90
Number of exacerbations: 1 51 46 45
Number of exacerbations: 2 14 26 22
Number of exacerbations: 3 3 4 11
Number of exacerbations: 4 1 3 4
Number of exacerbations: 5 0 1 2
5.Secondary Outcome
Title Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)
Hide Description 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.
Time Frame End of treatment (Week 44/46)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included participants who were randomized.
Arm/Group Title Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Pooled Placebo
Hide Arm/Group Description:
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).
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).
Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
Overall Number of Participants Analyzed 171 176 174
Measure Type: Number
Unit of Measure: Percentage of participants
No 35.1 35.8 40.2
Yes 31.6 35.8 31.6
6.Secondary Outcome
Title Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)
Hide Description 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.
Time Frame Baseline and end of treatment (Week 44/46)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS with participants evaluable for this outcome measure.
Arm/Group Title Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Placebo 28 Days on/Off (Placebo 28) Placebo 14 Days on/Off (Placebo 14)
Hide Arm/Group Description:
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).
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).
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).
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).
Overall Number of Participants Analyzed 142 142 67 72
Mean (Standard Deviation)
Unit of Measure: Score on a scale
-8.92  (21.06) -9.02  (20.10) -2.91  (24.48) -11.50  (18.54)
7.Secondary Outcome
Title Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)
Hide Description 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.
Time Frame End of treatment (Week 44/46)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included participants who were randomized.
Arm/Group Title Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Pooled Placebo
Hide Arm/Group Description:
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).
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).
Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
Overall Number of Participants Analyzed 171 176 174
Measure Type: Number
Unit of Measure: Percentage of participants
No 62.6 67.6 61.5
Yes 4.1 4.0 10.3
8.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline and end of treatment (Week 44/46)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS with participants evaluable for this outcome measure.
Arm/Group Title Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Placebo 28 Days on/Off (Placebo 28) Placebo 14 Days on/Off (Placebo 14)
Hide Arm/Group Description:
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).
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).
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).
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).
Overall Number of Participants Analyzed 85 94 43 49
Mean (Standard Deviation)
Unit of Measure: Score on a scale
11.57  (17.49) 10.90  (18.07) 7.08  (17.00) 10.70  (15.58)
9.Secondary Outcome
Title Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)
Hide Description 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).
Time Frame Baseline and end of treatment (Week 44/46)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS with participants evaluable for this outcome measure.
Arm/Group Title Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Placebo 28 Days on/Off (Placebo 28) Placebo 14 Days on/Off (Placebo 14)
Hide Arm/Group Description:
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).
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).
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).
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).
Overall Number of Participants Analyzed 138 140 62 71
Mean (Standard Deviation)
Unit of Measure: Liter
0.038  (0.336) -0.037  (0.287) -0.038  (0.272) 0.037  (0.299)
Time Frame From start of study treatment up to 30 days after the last study drug administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Pooled Placebo
Hide Arm/Group Description Subjects received ciprofloxacin (BAYQ3939) 32.5 mg corresponding to 50 mg DPI 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 active cycles). 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). Subjects received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
All-Cause Mortality
Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Pooled Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Pooled Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/171 (16.37%)      45/174 (25.86%)      41/174 (23.56%)    
Blood and lymphatic system disorders       
Febrile neutropenia * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Cardiac disorders       
Atrial flutter * 1  1/171 (0.58%)  1 0/174 (0.00%)  0 0/174 (0.00%)  0
Cor pulmonale * 1  1/171 (0.58%)  1 0/174 (0.00%)  0 0/174 (0.00%)  0
Congestive cardiomyopathy * 1  1/171 (0.58%)  1 0/174 (0.00%)  0 0/174 (0.00%)  0
Ear and labyrinth disorders       
Meniere's disease * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Eye disorders       
Vitreous detachment * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Gastrointestinal disorders       
Colitis * 1  1/171 (0.58%)  2 0/174 (0.00%)  0 0/174 (0.00%)  0
Diverticulum intestinal * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Gastrointestinal haemorrhage * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Inguinal hernia * 1  1/171 (0.58%)  1 0/174 (0.00%)  0 0/174 (0.00%)  0
Oesophageal obstruction * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Upper gastrointestinal haemorrhage * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Gastric disorder * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Hepatobiliary disorders       
Cholangitis * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Cholecystitis * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Infections and infestations       
Chronic sinusitis * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Diverticulitis * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Herpes zoster * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Pneumonia * 1  3/171 (1.75%)  4 2/174 (1.15%)  2 2/174 (1.15%)  2
Pneumonia viral * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Sepsis * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Viral upper respiratory tract infection * 1  1/171 (0.58%)  1 0/174 (0.00%)  0 0/174 (0.00%)  0
Bronchitis bacterial * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Respiratory tract infection viral * 1  1/171 (0.58%)  1 0/174 (0.00%)  0 0/174 (0.00%)  0
Infective exacerbation of bronchiectasis * 1  0/171 (0.00%)  0 3/174 (1.72%)  3 2/174 (1.15%)  4
Injury, poisoning and procedural complications       
Femur fracture * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Metabolism and nutrition disorders       
Hypoproteinaemia * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Osteoarthritis * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 1/174 (0.57%)  1
Rheumatoid arthritis * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma of colon * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Colon cancer * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Glottis carcinoma * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Haemangioma * 1  1/171 (0.58%)  1 0/174 (0.00%)  0 0/174 (0.00%)  0
Oesophageal carcinoma * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Pancreatic carcinoma * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Nervous system disorders       
Cerebrovascular accident * 1  1/171 (0.58%)  1 0/174 (0.00%)  0 0/174 (0.00%)  0
Transient ischaemic attack * 1  1/171 (0.58%)  1 0/174 (0.00%)  0 0/174 (0.00%)  0
Carotid artery occlusion * 1  1/171 (0.58%)  1 0/174 (0.00%)  0 0/174 (0.00%)  0
Ischaemic stroke * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous * 1  1/171 (0.58%)  1 0/174 (0.00%)  0 0/174 (0.00%)  0
Psychiatric disorders       
Suicide attempt * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Reproductive system and breast disorders       
Adenomyosis * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Bronchiectasis * 1  17/171 (9.94%)  20 24/174 (13.79%)  27 21/174 (12.07%)  31
Chronic obstructive pulmonary disease * 1  0/171 (0.00%)  0 3/174 (1.72%)  6 1/174 (0.57%)  1
Dyspnoea exertional * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
Haemoptysis * 1  2/171 (1.17%)  3 3/174 (1.72%)  3 4/174 (2.30%)  4
Pulmonary embolism * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Respiratory failure * 1  0/171 (0.00%)  0 1/174 (0.57%)  1 0/174 (0.00%)  0
Vascular disorders       
Hypertensive crisis * 1  0/171 (0.00%)  0 0/174 (0.00%)  0 1/174 (0.57%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ciprofloxacin DPI 28 Days on/Off (Cipro 28) Ciprofloxacin DPI 14 Days on/Off (Cipro 14) Pooled Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/171 (29.82%)      60/174 (34.48%)      55/174 (31.61%)    
Infections and infestations       
Nasopharyngitis * 1  10/171 (5.85%)  11 16/174 (9.20%)  19 14/174 (8.05%)  18
Upper respiratory tract infection * 1  10/171 (5.85%)  13 8/174 (4.60%)  10 5/174 (2.87%)  6
Nervous system disorders       
Dysgeusia * 1  9/171 (5.26%)  13 8/174 (4.60%)  16 2/174 (1.15%)  2
Headache * 1  10/171 (5.85%)  15 10/174 (5.75%)  11 5/174 (2.87%)  5
Respiratory, thoracic and mediastinal disorders       
Bronchospasm * 1  3/171 (1.75%)  3 7/174 (4.02%)  7 9/174 (5.17%)  9
Cough * 1  5/171 (2.92%)  9 7/174 (4.02%)  7 11/174 (6.32%)  12
Dyspnoea * 1  4/171 (2.34%)  5 10/174 (5.75%)  11 3/174 (1.72%)  6
Haemoptysis * 1  11/171 (6.43%)  19 15/174 (8.62%)  22 20/174 (11.49%)  41
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bayer acknowledges and accepts the interest in the non-commercial scientific publication of Results. In a multi-center study the Principal Investigators will not make any publication of the results before the first multi-center publication. Proposed publication/presentation shall be provided to Bayer at least 60 days prior to the intended submission or presentation of the publication in order to allow Bayer to review it. Any difference of opinion shall be discussed.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: BAYER
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02106832     History of Changes
Other Study ID Numbers: 15626
2013-004659-19 ( EudraCT Number )
First Submitted: April 4, 2014
First Posted: April 8, 2014
Results First Submitted: August 2, 2017
Results First Posted: September 1, 2017
Last Update Posted: October 2, 2017