Trial Outcomes & Findings for Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) (NCT NCT02106832)
NCT ID: NCT02106832
Last Updated: 2017-10-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
521 participants
Primary outcome timeframe
Up to Week 48
Results posted on
2017-10-02
Participant Flow
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).
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.
Participant milestones
| Measure |
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).
|
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 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 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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
171
|
176
|
86
|
88
|
|
Overall Study
Participants Received Treatment
|
171
|
174
|
86
|
88
|
|
Overall Study
COMPLETED
|
148
|
151
|
70
|
73
|
|
Overall Study
NOT COMPLETED
|
23
|
25
|
16
|
15
|
Reasons for withdrawal
| Measure |
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).
|
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 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 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).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
3
|
0
|
|
Overall Study
Death
|
4
|
4
|
1
|
4
|
|
Overall Study
Deterioration of general conditions
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
17
|
17
|
10
|
7
|
|
Overall Study
Technical problems
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Baseline characteristics by cohort
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=171 Participants
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)
n=176 Participants
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)
n=86 Participants
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)
n=88 Participants
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
n=521 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.3 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
60.4 Years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
60.6 Years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
60.4 Years
STANDARD_DEVIATION 15.0 • n=4 Participants
|
60.1 Years
STANDARD_DEVIATION 14.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
302 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
219 Participants
n=21 Participants
|
|
Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score
|
60.75 Score on a scale
STANDARD_DEVIATION 20.61 • n=5 Participants
|
61.26 Score on a scale
STANDARD_DEVIATION 19.54 • n=7 Participants
|
58.56 Score on a scale
STANDARD_DEVIATION 19.17 • n=5 Participants
|
63.47 Score on a scale
STANDARD_DEVIATION 19.48 • n=4 Participants
|
61.00 Score on a scale
STANDARD_DEVIATION 19.82 • n=21 Participants
|
|
Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score
|
50.14 Score on a scale
STANDARD_DEVIATION 19.07 • n=5 Participants
|
52.17 Score on a scale
STANDARD_DEVIATION 18.49 • n=7 Participants
|
53.95 Score on a scale
STANDARD_DEVIATION 16.00 • n=5 Participants
|
48.67 Score on a scale
STANDARD_DEVIATION 17.72 • n=4 Participants
|
51.22 Score on a scale
STANDARD_DEVIATION 18.16 • n=21 Participants
|
|
Forced Expiratory Volume in One Second (FEV1)
|
1.569 Liter
STANDARD_DEVIATION 0.602 • n=5 Participants
|
1.519 Liter
STANDARD_DEVIATION 0.617 • n=7 Participants
|
1.560 Liter
STANDARD_DEVIATION 0.692 • n=5 Participants
|
1.477 Liter
STANDARD_DEVIATION 0.558 • n=4 Participants
|
1.535 Liter
STANDARD_DEVIATION 0.615 • n=21 Participants
|
PRIMARY outcome
Timeframe: Up to Week 48Population: Full analysis set (FAS) included participants who were randomized.
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.
Outcome measures
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=171 Participants
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).
|
Pooled Placebo
n=174 Participants
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).
|
Pooled Placebo
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).
|
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).
|
|---|---|---|---|---|
|
Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo
|
NA Days
Value cannot be estimated due to censored data.
|
NA Days
Interval 211.0 to
Value cannot be estimated due to censored data.
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Week 48Population: Full analysis set (FAS) included participants who were randomized.
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.
Outcome measures
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=176 Participants
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).
|
Pooled Placebo
n=174 Participants
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).
|
Pooled Placebo
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).
|
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).
|
|---|---|---|---|---|
|
Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo
|
NA Days
Value cannot be estimated due to censored data.
|
NA Days
Interval 278.0 to
Value cannot be estimated due to censored data.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Full analysis set (FAS) included participants who were randomized.
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.
Outcome measures
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=171 Participants
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).
|
Pooled Placebo
n=176 Participants
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).
|
Pooled Placebo
n=174 Participants
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).
|
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).
|
|---|---|---|---|---|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 0
|
115 Participants
|
108 Participants
|
101 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 1
|
46 Participants
|
40 Participants
|
41 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 2
|
8 Participants
|
23 Participants
|
19 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 3
|
2 Participants
|
4 Participants
|
10 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 4
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 5
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Full analysis set (FAS) included participants who were randomized.
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.
Outcome measures
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=171 Participants
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).
|
Pooled Placebo
n=176 Participants
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).
|
Pooled Placebo
n=174 Participants
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).
|
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).
|
|---|---|---|---|---|
|
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Number of exacerbations: 0
|
102 Participants
|
96 Participants
|
90 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Number of exacerbations: 1
|
51 Participants
|
46 Participants
|
45 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Number of exacerbations: 2
|
14 Participants
|
26 Participants
|
22 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Number of exacerbations: 3
|
3 Participants
|
4 Participants
|
11 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Number of exacerbations: 4
|
1 Participants
|
3 Participants
|
4 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Number of exacerbations: 5
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: End of treatment (Week 44/46)Population: Full analysis set (FAS) included participants who were randomized.
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.
Outcome measures
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=171 Participants
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).
|
Pooled Placebo
n=176 Participants
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).
|
Pooled Placebo
n=174 Participants
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).
|
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).
|
|---|---|---|---|---|
|
Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)
No
|
35.1 Percentage of participants
|
35.8 Percentage of participants
|
40.2 Percentage of participants
|
—
|
|
Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)
Yes
|
31.6 Percentage of participants
|
35.8 Percentage of participants
|
31.6 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (Week 44/46)Population: FAS with participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=142 Participants
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).
|
Pooled Placebo
n=142 Participants
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).
|
Pooled Placebo
n=67 Participants
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).
|
Placebo 14 Days on/Off (Placebo 14)
n=72 Participants
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).
|
|---|---|---|---|---|
|
Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)
|
-8.92 Score on a scale
Standard Deviation 21.06
|
-9.02 Score on a scale
Standard Deviation 20.10
|
-2.91 Score on a scale
Standard Deviation 24.48
|
-11.50 Score on a scale
Standard Deviation 18.54
|
SECONDARY outcome
Timeframe: End of treatment (Week 44/46)Population: Full analysis set (FAS) included participants who were randomized.
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.
Outcome measures
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=171 Participants
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).
|
Pooled Placebo
n=176 Participants
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).
|
Pooled Placebo
n=174 Participants
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).
|
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).
|
|---|---|---|---|---|
|
Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)
No
|
62.6 Percentage of participants
|
67.6 Percentage of participants
|
61.5 Percentage of participants
|
—
|
|
Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)
Yes
|
4.1 Percentage of participants
|
4.0 Percentage of participants
|
10.3 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (Week 44/46)Population: FAS with participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=85 Participants
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).
|
Pooled Placebo
n=94 Participants
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).
|
Pooled Placebo
n=43 Participants
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).
|
Placebo 14 Days on/Off (Placebo 14)
n=49 Participants
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).
|
|---|---|---|---|---|
|
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)
|
11.57 Score on a scale
Standard Deviation 17.49
|
10.90 Score on a scale
Standard Deviation 18.07
|
7.08 Score on a scale
Standard Deviation 17.00
|
10.70 Score on a scale
Standard Deviation 15.58
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (Week 44/46)Population: FAS with participants evaluable for this outcome measure.
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).
Outcome measures
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=138 Participants
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).
|
Pooled Placebo
n=140 Participants
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).
|
Pooled Placebo
n=62 Participants
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).
|
Placebo 14 Days on/Off (Placebo 14)
n=71 Participants
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).
|
|---|---|---|---|---|
|
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)
|
0.038 Liter
Standard Deviation 0.336
|
-0.037 Liter
Standard Deviation 0.287
|
-0.038 Liter
Standard Deviation 0.272
|
0.037 Liter
Standard Deviation 0.299
|
Adverse Events
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
Serious events: 28 serious events
Other events: 51 other events
Deaths: 0 deaths
Ciprofloxacin DPI 14 Days on/Off (Cipro 14)
Serious events: 45 serious events
Other events: 60 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 41 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=171 participants at risk
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).
|
Ciprofloxacin DPI 14 Days on/Off (Cipro 14)
n=174 participants at risk
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).
|
Pooled Placebo
n=174 participants at risk
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).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Cardiac disorders
Atrial flutter
|
0.58%
1/171 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Cardiac disorders
Cor pulmonale
|
0.58%
1/171 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.58%
1/171 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Gastrointestinal disorders
Colitis
|
0.58%
1/171 • Number of events 2 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.58%
1/171 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Pneumonia
|
1.8%
3/171 • Number of events 4 • From start of study treatment up to 30 days after the last study drug administration.
|
1.1%
2/174 • Number of events 2 • From start of study treatment up to 30 days after the last study drug administration.
|
1.1%
2/174 • Number of events 2 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Sepsis
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.58%
1/171 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.58%
1/171 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
1.7%
3/174 • Number of events 3 • From start of study treatment up to 30 days after the last study drug administration.
|
1.1%
2/174 • Number of events 4 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glottis carcinoma
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.58%
1/171 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.58%
1/171 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.58%
1/171 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.58%
1/171 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.58%
1/171 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
9.9%
17/171 • Number of events 20 • From start of study treatment up to 30 days after the last study drug administration.
|
13.8%
24/174 • Number of events 27 • From start of study treatment up to 30 days after the last study drug administration.
|
12.1%
21/174 • Number of events 31 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
1.7%
3/174 • Number of events 6 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
2/171 • Number of events 3 • From start of study treatment up to 30 days after the last study drug administration.
|
1.7%
3/174 • Number of events 3 • From start of study treatment up to 30 days after the last study drug administration.
|
2.3%
4/174 • Number of events 4 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/171 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/174 • From start of study treatment up to 30 days after the last study drug administration.
|
0.57%
1/174 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
Other adverse events
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=171 participants at risk
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).
|
Ciprofloxacin DPI 14 Days on/Off (Cipro 14)
n=174 participants at risk
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).
|
Pooled Placebo
n=174 participants at risk
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).
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.8%
10/171 • Number of events 11 • From start of study treatment up to 30 days after the last study drug administration.
|
9.2%
16/174 • Number of events 19 • From start of study treatment up to 30 days after the last study drug administration.
|
8.0%
14/174 • Number of events 18 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
10/171 • Number of events 13 • From start of study treatment up to 30 days after the last study drug administration.
|
4.6%
8/174 • Number of events 10 • From start of study treatment up to 30 days after the last study drug administration.
|
2.9%
5/174 • Number of events 6 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Dysgeusia
|
5.3%
9/171 • Number of events 13 • From start of study treatment up to 30 days after the last study drug administration.
|
4.6%
8/174 • Number of events 16 • From start of study treatment up to 30 days after the last study drug administration.
|
1.1%
2/174 • Number of events 2 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Headache
|
5.8%
10/171 • Number of events 15 • From start of study treatment up to 30 days after the last study drug administration.
|
5.7%
10/174 • Number of events 11 • From start of study treatment up to 30 days after the last study drug administration.
|
2.9%
5/174 • Number of events 5 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.8%
3/171 • Number of events 3 • From start of study treatment up to 30 days after the last study drug administration.
|
4.0%
7/174 • Number of events 7 • From start of study treatment up to 30 days after the last study drug administration.
|
5.2%
9/174 • Number of events 9 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
5/171 • Number of events 9 • From start of study treatment up to 30 days after the last study drug administration.
|
4.0%
7/174 • Number of events 7 • From start of study treatment up to 30 days after the last study drug administration.
|
6.3%
11/174 • Number of events 12 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
4/171 • Number of events 5 • From start of study treatment up to 30 days after the last study drug administration.
|
5.7%
10/174 • Number of events 11 • From start of study treatment up to 30 days after the last study drug administration.
|
1.7%
3/174 • Number of events 6 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.4%
11/171 • Number of events 19 • From start of study treatment up to 30 days after the last study drug administration.
|
8.6%
15/174 • Number of events 22 • From start of study treatment up to 30 days after the last study drug administration.
|
11.5%
20/174 • Number of events 41 • From start of study treatment up to 30 days after the last study drug administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER