Trial Outcomes & Findings for Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) (NCT NCT01764841)
NCT ID: NCT01764841
Last Updated: 2018-01-24
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
416 participants
Primary outcome timeframe
Up to Week 48
Results posted on
2018-01-24
Participant Flow
Study was conducted at 124 study centers in 14 countries (Argentina, Australia, Denmark, France, Germany, Israel, Italy, Japan, Latvia, New Zealand, Slovakia, Spain, UK and US) between 02 May 2013 (first subject first visit) and 09 March 2016 (last subject last visit).
Overall 902 participants were screened, of them 486 were screen failures, and 416 were randomized, out of which 414 participants were assigned to the treatment. One participant from Ciprofloxacin 14 Days on/off group and one participant from Placebo 28 Days on/off group did not receive the study treatment after initial screening.
Participant milestones
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
Participants 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)
Participants 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)
Participants 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)
Participants 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
|
141
|
137
|
70
|
68
|
|
Overall Study
Participants Received Treatment
|
141
|
136
|
69
|
68
|
|
Overall Study
COMPLETED
|
118
|
111
|
56
|
49
|
|
Overall Study
NOT COMPLETED
|
23
|
26
|
14
|
19
|
Reasons for withdrawal
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
Participants 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)
Participants 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)
Participants 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)
Participants 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
Logistical Difficulties
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
3
|
0
|
1
|
4
|
|
Overall Study
No Follow Up
|
1
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
16
|
24
|
11
|
15
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
1
|
0
|
Baseline Characteristics
Participants with data available for this measure at baseline.
Baseline characteristics by cohort
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=141 Participants
Participants 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=137 Participants
Participants 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=70 Participants
Participants 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=68 Participants
Participants 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=416 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.2 Years
STANDARD_DEVIATION 12.1 • n=141 Participants
|
65.2 Years
STANDARD_DEVIATION 13.5 • n=137 Participants
|
64 Years
STANDARD_DEVIATION 13.5 • n=70 Participants
|
65.5 Years
STANDARD_DEVIATION 12.9 • n=68 Participants
|
64.7 Years
STANDARD_DEVIATION 12.9 • n=416 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=141 Participants
|
88 Participants
n=137 Participants
|
52 Participants
n=70 Participants
|
44 Participants
n=68 Participants
|
285 Participants
n=416 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=141 Participants
|
49 Participants
n=137 Participants
|
18 Participants
n=70 Participants
|
24 Participants
n=68 Participants
|
131 Participants
n=416 Participants
|
|
Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score
|
60.72 Score on a scale
STANDARD_DEVIATION 19.47 • n=135 Participants • Participants with data available for this measure at baseline.
|
52.51 Score on a scale
STANDARD_DEVIATION 21.48 • n=129 Participants • Participants with data available for this measure at baseline.
|
55.52 Score on a scale
STANDARD_DEVIATION 22.07 • n=67 Participants • Participants with data available for this measure at baseline.
|
58.72 Score on a scale
STANDARD_DEVIATION 20.4 • n=66 Participants • Participants with data available for this measure at baseline.
|
56.84 Score on a scale
STANDARD_DEVIATION 20.95 • n=397 Participants • Participants with data available for this measure at baseline.
|
|
Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score
|
53.01 Score on a scale
STANDARD_DEVIATION 18.71 • n=128 Participants • Participants with data available for this measure at baseline.
|
57.69 Score on a scale
STANDARD_DEVIATION 18.72 • n=120 Participants • Participants with data available for this measure at baseline.
|
55.82 Score on a scale
STANDARD_DEVIATION 18.04 • n=63 Participants • Participants with data available for this measure at baseline.
|
50.67 Score on a scale
STANDARD_DEVIATION 19.59 • n=65 Participants • Participants with data available for this measure at baseline.
|
54.57 Score on a scale
STANDARD_DEVIATION 18.87 • n=376 Participants • Participants with data available for this measure at baseline.
|
|
Forced Expiratory Volume in One Second (FEV1)
|
1.521 Liter
STANDARD_DEVIATION 0.521 • n=141 Participants
|
1.528 Liter
STANDARD_DEVIATION 0.625 • n=137 Participants
|
1.577 Liter
STANDARD_DEVIATION 0.651 • n=70 Participants
|
1.468 Liter
STANDARD_DEVIATION 0.574 • n=68 Participants
|
1.524 Liter
STANDARD_DEVIATION 0.587 • n=416 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=141 Participants
Participants 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=137 Participants
Participants 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=138 Participants
Participants 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 or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
|
Placebo 14 Days on/Off (Placebo 14)
Participants 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
|
336 Days
Interval 206.0 to
Value cannot be estimated due to censored data.
|
NA Days
Interval 290.0 to
Value cannot be estimated due to censored data.
|
186 Days
Interval 136.0 to 282.0
|
—
|
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=141 Participants
Participants 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=137 Participants
Participants 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=138 Participants
Participants 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 or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
|
Placebo 14 Days on/Off (Placebo 14)
Participants 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
|
66 Participants
|
72 Participants
|
44 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 1
|
44 Participants
|
38 Participants
|
58 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 2
|
12 Participants
|
13 Participants
|
19 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 3
|
12 Participants
|
8 Participants
|
7 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 4
|
3 Participants
|
3 Participants
|
8 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 5
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 6
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Number of exacerbations: 7
|
3 Participants
|
1 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=141 Participants
Participants 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=137 Participants
Participants 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=138 Participants
Participants 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 or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
|
Placebo 14 Days on/Off (Placebo 14)
Participants 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
|
58 Participants
|
68 Participants
|
46 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Number of exacerbations: 1
|
47 Participants
|
42 Participants
|
43 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Number of exacerbations: 2
|
12 Participants
|
15 Participants
|
31 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Number of exacerbations: 3
|
14 Participants
|
5 Participants
|
11 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Number of exacerbations: 4
|
4 Participants
|
2 Participants
|
5 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Number of exacerbations: 5
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Number of exacerbations: 6
|
2 Participants
|
2 Participants
|
0 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=141 Participants
Participants 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=137 Participants
Participants 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=138 Participants
Participants 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 or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
|
Placebo 14 Days on/Off (Placebo 14)
Participants 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
|
39.0 Percentage of Participants
|
26.3 Percentage of Participants
|
33.3 Percentage of Participants
|
—
|
|
Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)
Yes
|
24.1 Percentage of Participants
|
28.5 Percentage of Participants
|
16.7 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=115 Participants
Participants 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=101 Participants
Participants 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=46 Participants
Participants 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 or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
|
Placebo 14 Days on/Off (Placebo 14)
n=45 Participants
Participants 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)
|
-8.17 Score on a scale
Standard Deviation 22.92
|
-7.20 Score on a scale
Standard Deviation 20.41
|
-4.23 Score on a scale
Standard Deviation 19.55
|
2.78 Score on a scale
Standard Deviation 16.16
|
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=141 Participants
Participants 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=137 Participants
Participants 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=138 Participants
Participants 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 or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
|
Placebo 14 Days on/Off (Placebo 14)
Participants 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
|
60.3 Percentage of Participants
|
49.6 Percentage of Participants
|
42.8 Percentage of Participants
|
—
|
|
Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)
Yes
|
3.5 Percentage of Participants
|
5.1 Percentage of Participants
|
8.0 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=110 Participants
Participants 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=95 Participants
Participants 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=46 Participants
Participants 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 or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
|
Placebo 14 Days on/Off (Placebo 14)
n=44 Participants
Participants 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)
|
7.70 Score on a scale
Standard Deviation 18.50
|
6.72 Score on a scale
Standard Deviation 17.90
|
8.22 Score on a scale
Standard Deviation 16.74
|
4.45 Score on a scale
Standard Deviation 17.78
|
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=112 Participants
Participants 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=98 Participants
Participants 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=45 Participants
Participants 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 or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
|
Placebo 14 Days on/Off (Placebo 14)
n=41 Participants
Participants 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)
|
-0.012 Liter
Standard Deviation 0.149
|
-0.026 Liter
Standard Deviation 0.226
|
0.024 Liter
Standard Deviation 0.344
|
0.022 Liter
Standard Deviation 0.352
|
Adverse Events
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
Serious events: 29 serious events
Other events: 74 other events
Deaths: 0 deaths
Ciprofloxacin DPI 14 Days on/Off (Cipro 14)
Serious events: 23 serious events
Other events: 83 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 32 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ciprofloxacin DPI 28 Days on/Off (Cipro 28)
n=141 participants at risk
Participants 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=136 participants at risk
Participants 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=137 participants at risk
Participants 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
Anaemia
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Cardiac disorders
Atrial flutter
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
1.5%
2/137 • Number of events 2 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Cardiac disorders
Cor pulmonale
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Eye disorders
Angle closure glaucoma
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Eye disorders
Retinal vasculitis
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
General disorders
Strangulated hernia
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
General disorders
Peripheral swelling
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
General disorders
General physical health deterioration
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Bronchiolitis
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Cellulitis
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Influenza
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Pathogen resistance
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Pneumonia
|
2.8%
4/141 • Number of events 4 • From start of study treatment up to 30 days after the last study drug administration.
|
2.9%
4/136 • Number of events 4 • From start of study treatment up to 30 days after the last study drug administration.
|
3.6%
5/137 • Number of events 5 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Urosepsis
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
1.4%
2/141 • Number of events 3 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Injury, poisoning and procedural complications
Complications of transplant surgery
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Injury, poisoning and procedural complications
Urethral stricture traumatic
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Investigations
Influenza A virus test positive
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • 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)
Breast cancer
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • 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)
Squamous cell carcinoma of skin
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • 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)
Thyroid cancer recurrent
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Paraesthesia
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Syncope
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 2 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Reproductive system and breast disorders
Prostatic haemorrhage
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
11.3%
16/141 • Number of events 20 • From start of study treatment up to 30 days after the last study drug administration.
|
5.9%
8/136 • Number of events 9 • From start of study treatment up to 30 days after the last study drug administration.
|
12.4%
17/137 • Number of events 19 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • 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
|
1.4%
2/141 • Number of events 2 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
1.5%
2/137 • Number of events 2 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.74%
1/136 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/141 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Pyometra
|
0.71%
1/141 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/136 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • 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=141 participants at risk
Participants 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=136 participants at risk
Participants 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=137 participants at risk
Participants 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).
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
7/141 • Number of events 7 • From start of study treatment up to 30 days after the last study drug administration.
|
6.6%
9/136 • Number of events 11 • From start of study treatment up to 30 days after the last study drug administration.
|
3.6%
5/137 • Number of events 5 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Gastrointestinal disorders
Nausea
|
3.5%
5/141 • Number of events 5 • From start of study treatment up to 30 days after the last study drug administration.
|
7.4%
10/136 • Number of events 11 • From start of study treatment up to 30 days after the last study drug administration.
|
5.1%
7/137 • Number of events 7 • From start of study treatment up to 30 days after the last study drug administration.
|
|
General disorders
Chest pain
|
3.5%
5/141 • Number of events 5 • From start of study treatment up to 30 days after the last study drug administration.
|
5.1%
7/136 • Number of events 8 • From start of study treatment up to 30 days after the last study drug administration.
|
5.1%
7/137 • Number of events 7 • From start of study treatment up to 30 days after the last study drug administration.
|
|
General disorders
Fatigue
|
4.3%
6/141 • Number of events 6 • From start of study treatment up to 30 days after the last study drug administration.
|
8.8%
12/136 • Number of events 14 • From start of study treatment up to 30 days after the last study drug administration.
|
2.2%
3/137 • Number of events 3 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Nasopharyngitis
|
10.6%
15/141 • Number of events 20 • From start of study treatment up to 30 days after the last study drug administration.
|
11.8%
16/136 • Number of events 21 • From start of study treatment up to 30 days after the last study drug administration.
|
7.3%
10/137 • Number of events 15 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Sinusitis
|
2.8%
4/141 • Number of events 5 • From start of study treatment up to 30 days after the last study drug administration.
|
7.4%
10/136 • Number of events 12 • From start of study treatment up to 30 days after the last study drug administration.
|
5.8%
8/137 • Number of events 10 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
4/141 • Number of events 5 • From start of study treatment up to 30 days after the last study drug administration.
|
6.6%
9/136 • Number of events 9 • From start of study treatment up to 30 days after the last study drug administration.
|
7.3%
10/137 • Number of events 13 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Investigations
Aspergillus test positive
|
4.3%
6/141 • Number of events 6 • From start of study treatment up to 30 days after the last study drug administration.
|
5.1%
7/136 • Number of events 8 • From start of study treatment up to 30 days after the last study drug administration.
|
0.00%
0/137 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
10/141 • Number of events 13 • From start of study treatment up to 30 days after the last study drug administration.
|
6.6%
9/136 • Number of events 10 • From start of study treatment up to 30 days after the last study drug administration.
|
4.4%
6/137 • Number of events 6 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Dizziness
|
1.4%
2/141 • Number of events 2 • From start of study treatment up to 30 days after the last study drug administration.
|
5.1%
7/136 • Number of events 7 • From start of study treatment up to 30 days after the last study drug administration.
|
0.73%
1/137 • Number of events 1 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Nervous system disorders
Headache
|
7.8%
11/141 • Number of events 14 • From start of study treatment up to 30 days after the last study drug administration.
|
10.3%
14/136 • Number of events 16 • From start of study treatment up to 30 days after the last study drug administration.
|
2.9%
4/137 • Number of events 6 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.3%
6/141 • Number of events 7 • From start of study treatment up to 30 days after the last study drug administration.
|
5.1%
7/136 • Number of events 13 • From start of study treatment up to 30 days after the last study drug administration.
|
7.3%
10/137 • Number of events 13 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.6%
15/141 • Number of events 18 • From start of study treatment up to 30 days after the last study drug administration.
|
9.6%
13/136 • Number of events 18 • From start of study treatment up to 30 days after the last study drug administration.
|
6.6%
9/137 • 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
|
10.6%
15/141 • Number of events 21 • From start of study treatment up to 30 days after the last study drug administration.
|
11.8%
16/136 • Number of events 26 • From start of study treatment up to 30 days after the last study drug administration.
|
6.6%
9/137 • Number of events 11 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
10.6%
15/141 • Number of events 34 • From start of study treatment up to 30 days after the last study drug administration.
|
11.8%
16/136 • Number of events 32 • From start of study treatment up to 30 days after the last study drug administration.
|
5.8%
8/137 • Number of events 10 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
5.7%
8/141 • Number of events 9 • From start of study treatment up to 30 days after the last study drug administration.
|
4.4%
6/136 • Number of events 8 • From start of study treatment up to 30 days after the last study drug administration.
|
2.2%
3/137 • Number of events 4 • From start of study treatment up to 30 days after the last study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.1%
3/141 • Number of events 3 • From start of study treatment up to 30 days after the last study drug administration.
|
5.1%
7/136 • Number of events 9 • From start of study treatment up to 30 days after the last study drug administration.
|
3.6%
5/137 • Number of events 5 • 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 noncommercial scientific publication of Results. In a multicenter study the PIs 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