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Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis

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ClinicalTrials.gov Identifier: NCT00930982
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : January 30, 2012
Last Update Posted : December 12, 2014
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bronchiectasis
Interventions Drug: Ciprofloxacin (Cipro, BAYQ3939)
Drug: Placebo
Enrollment 124
Recruitment Details Pulmonary stable participants with a proven and documented diagnosis of non-cystic fibrosis bronchiectasis (idiopathic or postpneumonic), and on a stable regimen of standard treatment, were recruited at specialized study sites.
Pre-assignment Details Out of 277 participants screened, 153 failed screening (mostly due to not meeting in-/exclusion criteria or inability to produce adequate sputum samples), and 124 participants were randomized (60 to Ciprofloxacin Inhale and 64 to placebo).
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily Inhalation of matching placebo twice a day
Period Title: Overall Study
Started 60 64
Completed 39 35
Not Completed 21 29
Reason Not Completed
Adverse Event             19             23
Protocol Violation             1             5
Withdrawal by Subject             1             1
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo Total
Hide Arm/Group Description 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily Inhalation of matching placebo twice a day Total of all reporting groups
Overall Number of Baseline Participants 60 64 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 64 participants 124 participants
64.7  (11.8) 61.4  (11.9) 63.0  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 64 participants 124 participants
Female
39
  65.0%
43
  67.2%
82
  66.1%
Male
21
  35.0%
21
  32.8%
42
  33.9%
1.Primary Outcome
Title Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29).
Hide Description Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of > 2 mL. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm
Time Frame Baseline and 29 days
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Mean (Standard Deviation)
Unit of Measure: log10 of CFU per gram sputum
-2.94  (3.40) -0.32  (2.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ciprofloxacin Inhale (BAYQ3939), Placebo
Comments Ho: CFU(EOT|Cipro) - CFU(baseline|Cipro) > CFU(EOT|Placebo) - CFU(baseline|Placebo) CFU = colony forming units EOT=End of treatment (Day 29) Sample size was based a difference of 1.2 log10 CFU/g between placebo and Ciprofloxacin and a standard deviation of 2 log10 CFU/g
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments p-value should be < 0.023 (one-sided) for a significant result as an interim analysis was performed. Results based on the no-interaction model which was defined as primary analysis.
Method ANCOVA
Comments Baseline cfu was covariate, treatment and pooled centers factors. As the p-value for interaction was 0.214, the no-interaction model is appropriate.
Method of Estimation Estimation Parameter Difference in Least square means
Estimated Value -2.368
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.674
Estimation Comments Least square mean Ciprofloxacin minus placebo
2.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. 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). Imputation method: last observation carried forward (LOCF).
Time Frame Baseline and up to end of study (planned at Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Mean (Standard Deviation)
Unit of Measure: Percent of predicted FEV1
Day 8 -0.67  (4.50) -0.14  (5.10)
Day 29 -0.53  (7.88) -0.22  (9.57)
Day 42 1.19  (5.88) -0.26  (9.88)
Day 56 0.81  (5.50) -0.24  (9.61)
Day 84 0.70  (5.69) -0.50  (7.62)
3.Secondary Outcome
Title Change From Baseline in Forced Vital Capacity (FVC)
Hide Description Pulmonary function testing (spirometry) was conducted in accordance with American Thoracic Society standards. FVC was defined as the maximal volume of air exhaled with maximally forced effort from a maximal inspiration, i.e. vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS. Imputation method: last observation carried forward (LOCF).
Time Frame Baseline and up to end of study (planned at Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Mean (Standard Deviation)
Unit of Measure: Percent of predicted FVC
Day 8 -0.33  (7.93) 0.04  (7.32)
Day 29 -0.76  (8.70) -1.05  (9.12)
Day 42 0.92  (8.98) -1.09  (9.46)
Day 56 0.36  (7.45) -1.16  (9.83)
Day 84 -0.01  (7.57) -1.99  (8.86)
4.Secondary Outcome
Title Time to Exacerbation With Antibiotic Intervention
Hide Description Acute exacerbation was defined according to the joint American Thoracic Society/European Respiratory Society criteria. For detailed information with regard to this definition of acute exacerbation, please refer to the detailed description in the protocol section. The time to an acute exacerbation with antibiotic intervention was determined.
Time Frame Up to end of study (planned at Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants. NA: due to fewer than 25% of participants having an exacerbation
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Median (Inter-Quartile Range)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA: due to fewer than 25% of participants having an exacerbation
5.Secondary Outcome
Title Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score
Hide Description Participants completed the Saint George's Respiratory Questionnaire (SGRQ). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges from 0 to 100 with 100 being the worst possible score.
Time Frame Up to end of study (planned at Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Day 1 43.8  (20.3) 44.7  (18.1)
Day 29 41.5  (21.0) 44.8  (19.8)
Day 56 40.6  (20.9) 44.1  (18.6)
Day 84 40.6  (18.1) 41.6  (17.0)
6.Secondary Outcome
Title Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS)
Hide Description Participants completed the Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS). They were assured that all data would be treated confidentially and that the answers would not have any influence on study drug treatment. Participants completed the questionnaires on their own in a quiet area, without discussing them with study staff or accompanying persons (e.g. friends or relatives) and before being seen by the clinician. The score ranges between 1 and 7, 1 being the worst possible score.
Time Frame Up to end of study (planned at Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Mean (Standard Deviation)
Unit of Measure: Total score on a scale
Day 1 4.88  (1.20) 4.96  (0.98)
Day 29 4.99  (1.21) 4.93  (1.21)
Day 56 4.94  (1.29) 4.91  (1.16)
Day 84 5.01  (1.21) 4.99  (1.06)
7.Secondary Outcome
Title Change From Baseline in High Sensitive C-reactive Protein (hsCRP)
Hide Description High sensitive C-reactive protein (hsCRP) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.
Time Frame Baseline and up to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Median (Inter-Quartile Range)
Unit of Measure: mg/L
Day 8
-0.43
(-4.10 to 0.40)
-0.19
(-2.48 to -0.19)
Day 29
0
(-3.50 to 1.90)
0
(-1.92 to 3.10)
Day 42
-0.16
(-4.40 to 1.91)
0.12
(-2.07 to 3.10)
8.Secondary Outcome
Title Change From Baseline in Absolute Neutrophil Count (ANC)
Hide Description Absolute neutrophil count (ANC) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.
Time Frame Baseline and up to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Mean (Standard Deviation)
Unit of Measure: giga/L
Day 8 -0.35  (1.59) -0.03  (1.45)
Day 29 -0.36  (1.69) 0.59  (1.97)
Day 42 -0.28  (1.70) 0.24  (2.21)
9.Secondary Outcome
Title 24-hour Sputum Volume
Hide Description Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. The volume of the completed sample was determined.
Time Frame Up to end of study (planned at Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Mean (Standard Deviation)
Unit of Measure: mL
Day 1 24.9  (23.6) 30.2  (25.2)
Day 8 18.9  (22.2) 30.0  (24.1)
Day 29 20.5  (25.3) 27.3  (32.5)
Day 42 21.1  (24.7) 22.8  (21.1)
Day 56 19.6  (24.8) 22.0  (24.8)
Day 84 23.6  (28.9) 25.9  (22.9)
10.Secondary Outcome
Title 24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)
Hide Description Participants were asked to start 24-hour sputum collection samples 24 hours before coming for the respective study visit. Sputum color was assessed as either 'clear', or as 'yellow', 'green' or 'rust', or an assessment of 'no sputum' was made.
Time Frame Up to end of study (planned at Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Measure Type: Number
Unit of Measure: Percentage of participants
Day 1 91.7 88.9
Day 8 73.2 94.9
Day 29 75.5 82.7
Day 42 72.8 88.4
Day 56 75.0 86.5
Day 84 66.6 72.8
11.Secondary Outcome
Title Microbiological Response of Cipro Inhale Per Participant
Hide Description Microbiological response was defined as reduction in bacterial load or eradication (measured as the percentage of participants with positive culture). Missing values were not imputed.
Time Frame Up to end of study (planned at Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Measure Type: Number
Unit of Measure: Percentage of participants
Day 1 100.0 100.0
Day 8 52.4 88.2
Day 29 65.0 91.8
Day 42 83.3 86.8
Day 56 87.1 96.4
Day 84 85.2 92.0
12.Secondary Outcome
Title Microbiological Response of Cipro Inhale Per Pathogen
Hide Description Microbiological response was defined as reduction in bacterial load or eradication (measured as the number of participants with positive culture). Missing values were not imputed. Pathogens analyzed: Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Proteus mirabilis, Serratia marcescens, Pseudomonas aeruginosa, mucoid, Pseudomonas aeruginosa, non mucoid, Stenotrophomonas maltophilia, Achromobacter xylosoxydans, Moraxella catarrhalis, Haemophilus influenzae
Time Frame Up to end of study (planned at Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Measure Type: Number
Unit of Measure: Participants
S. aureus Day 1 8 17
S. aureus Day 8 4 7
S. aureus Day 29 5 10
S. aureus Day 42 6 9
S. aureus Day 56 8 5
S. aureus Day 84 5 5
S. pneumoniae Day 1 7 2
S. pneumoniae Day 8 2 4
S. pneumoniae Day 29 0 4
S. pneumoniae Day 42 3 1
S. pneumoniae Day 56 1 2
S. pneumoniae Day 84 1 1
E. coli Day 1 2 2
E. coli Day 8 2 2
E. coli Day 29 2 1
E. coli Day 42 0 1
E. coli Day 56 1 0
E. coli Day 84 1 0
K. pneumoniae Day 1 5 0
K. pneumoniae Day 8 0 0
K. pneumoniae Day 29 0 0
K. pneumoniae Day 42 0 1
K. pneumoniae Day 56 1 0
K. pneumoniae Day 84 3 0
K. oxytoca Day 1 3 2
K. oxytoca Day 8 0 1
K. oxytoca Day 29 0 2
K. oxytoca Day 42 0 1
K. oxytoca Day 56 0 1
K. oxytoca Day 84 1 1
P. mirabilis Day 1 3 4
P. mirabilis Day 8 0 3
P. mirabilis Day 29 0 1
P. mirabilis Day 42 2 3
P. mirabilis Day 56 2 2
P. mirabilis Day 84 2 2
S. marcescens Day 1 2 3
S. marcescens Day 8 0 2
S. marcescens Day 29 0 3
S. marcescens Day 42 0 3
S. marcescens Day 56 0 2
S. marcescens Day 84 2 0
P. aeruginosa, mucoid Day 1 12 16
P. aeruginosa, mucoid Day 8 7 15
P. aeruginosa, mucoid Day 29 9 16
P. aeruginosa, mucoid Day 42 9 12
P. aeruginosa, mucoid Day 56 6 6
P. aeruginosa, mucoid Day 84 4 5
P. aeruginosa, non mucoid Day 1 20 19
P. aeruginosa, non mucoid Day 8 6 17
P. aeruginosa, non mucoid Day 29 10 14
P. aeruginosa, non mucoid Day 42 12 12
P. aeruginosa, non mucoid Day 56 10 9
P. aeruginosa, non mucoid Day 84 13 6
S. maltophilia Day 1 2 3
S. maltophilia Day 8 0 3
S. maltophilia Day 29 2 3
S. maltophilia Day 42 2 1
S. maltophilia Day 56 4 3
S. maltophilia Day 84 1 1
A. xylosoxydans Day 1 2 3
A. xylosoxydans Day 8 2 2
A. xylosoxydans Day 29 2 1
A. xylosoxydans Day 42 2 0
A. xylosoxydans Day 56 1 1
A. xylosoxydans Day 84 0 2
M. catarrhalis Day 1 5 3
M. catarrhalis Day 8 0 3
M. catarrhalis Day 29 0 6
M. catarrhalis Day 42 1 2
M. catarrhalis Day 56 1 2
M. catarrhalis Day 84 1 2
H. influenzae Day 1 14 16
H. influenzae Day 8 1 12
H. influenzae Day 29 1 11
H. influenzae Day 42 1 7
H. influenzae Day 56 3 8
H. influenzae Day 84 4 8
13.Secondary Outcome
Title Emergence of New Potential Respiratory Pathogens
Hide Description The emergence of new potential respiratory pathogens was evaluated using microbiological analysis. Evaluated was the cumulative number of participants with first appearance of new potential respiratory antigens at each time point. In some cases, participants attended the end of study visit later than Day 84 (up to Day 88).
Time Frame Up to end of study (planned at Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Measure Type: Number
Unit of Measure: Cumulative participants
Day 4 1 0
Day 5 1 2
Day 7 2 2
Day 8 7 8
Day 9 7 10
Day 10 7 11
Day 14 7 12
Day 15 7 13
Day 28 7 14
Day 29 12 24
Day 30 14 30
Day 36 15 30
Day 39 16 31
Day 42 18 33
Day 43 21 38
Day 44 25 40
Day 45 26 41
Day 57 29 45
Day 58 29 46
Day 59 30 47
Day 78 31 47
Day 83 32 47
Day 84 33 47
Day 85 38 53
Day 86 41 54
Day 88 43 54
14.Secondary Outcome
Title Emergence of Resistance Among Baseline Pathogens
Hide Description The emergence of resistance (at least two-fold increase of Minimal inhibitory concentration, MIC, vs. baseline values) probably or possibly related to study medication among baseline pathogens was evaluated using microbiological analysis.
Time Frame Up to end of study (planned at Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants.
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Measure Type: Number
Unit of Measure: Participants
Emergence (>= 2* increase of MIC) 7 1
Sustained (>= 2* increase of MIC until end) 1 0
Transient (Increase in MIC with normalization) 5 1
Insufficient follow up 1 0
15.Other Pre-specified Outcome
Title Change From Baseline in Total Bacterial Load in the Sputum
Hide Description Total bacterial load was determined in sputum collected before the inhalation of study drug. Sputum samples were either provided by the participant during the respective study visit, or participants had to bring a sputum sample that had been produced within the 4 hours prior to the visit. Induced sputum samples could be collected if the participant was unable to produce a spontaneously expectorated sputum sample of > 2 mL on Day 8. Imputation method: last observation carried forward (LOCF). CFU: colony forming units, log10: decadic logarithm
Time Frame Baseline and up to end of study (planned at Day 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (ITT) analyses were performed on all participants who had been randomized and received study drug. This population was identical to the ITT population of all randomized participants. Decadic logarithm of colony forming units (CFUs) per gram sputum
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Inhalation of matching placebo twice a day
Overall Number of Participants Analyzed 60 64
Mean (Standard Deviation)
Unit of Measure: log10 of CFU per gram sputum
Day 8 -2.87  (3.39) -0.20  (2.15)
Day 42 -1.86  (3.06) -0.31  (2.08)
Day 56 -1.86  (3.11) -0.21  (1.89)
Day 84 -1.37  (3.17) -0.24  (1.77)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ciprofloxacin Inhale (BAYQ3939) Placebo
Hide Arm/Group Description 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily Inhalation of matching placebo twice a day
All-Cause Mortality
Ciprofloxacin Inhale (BAYQ3939) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ciprofloxacin Inhale (BAYQ3939) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/60 (6.67%)      6/64 (9.38%)    
Blood and lymphatic system disorders     
Neutropenia * 1  0/60 (0.00%)  0 1/64 (1.56%)  1
Infections and infestations     
Bronchiectasis * 1  1/60 (1.67%)  1 5/64 (7.81%)  6
Sepsis * 1  0/60 (0.00%)  0 1/64 (1.56%)  1
Investigations     
Catheterisation cardiac * 1  0/60 (0.00%)  0 1/64 (1.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Oesophageal adenocarcinoma * 1  1/60 (1.67%)  1 0/64 (0.00%)  0
Nervous system disorders     
Complex regional pain syndrome * 1  1/60 (1.67%)  1 0/64 (0.00%)  0
Psychiatric disorders     
Hallucination * 1  1/60 (1.67%)  1 0/64 (0.00%)  0
Renal and urinary disorders     
Renal impairment * 1  0/60 (0.00%)  0 1/64 (1.56%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure * 1  0/60 (0.00%)  0 1/64 (1.56%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ciprofloxacin Inhale (BAYQ3939) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/60 (63.33%)      36/64 (56.25%)    
Gastrointestinal disorders     
Diarrhoea * 1  3/60 (5.00%)  3 2/64 (3.13%)  2
Nausea * 1  3/60 (5.00%)  3 0/64 (0.00%)  0
General disorders     
Product taste abnormal * 1  8/60 (13.33%)  8 7/64 (10.94%)  7
Infections and infestations     
Bronchiectasis * 1  22/60 (36.67%)  24 22/64 (34.38%)  23
Nervous system disorders     
Dysgeusia * 1  4/60 (6.67%)  4 1/64 (1.56%)  1
Headache * 1  6/60 (10.00%)  7 6/64 (9.38%)  8
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 1  3/60 (5.00%)  3 3/64 (4.69%)  3
Cough * 1  2/60 (3.33%)  2 5/64 (7.81%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator must send a draft manuscript of the publication or abstract to the sponsor 30 days in advance of submission in order to obtain written approval prior to submission of the final version for publication. This will be reviewed promptly and approval will not be withheld unreasonably. In case of a difference of opinion, the contents of the publication will be discussed in order to find a solution that satisfies both parties.
Results Point of Contact
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Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00930982    
Other Study ID Numbers: 12965
2009-009869-34 ( EudraCT Number )
First Submitted: June 30, 2009
First Posted: July 2, 2009
Results First Submitted: September 19, 2011
Results First Posted: January 30, 2012
Last Update Posted: December 12, 2014