A Phase 2 interventional study of Ciprofloxacin (Cipro, BAYQ3939) and Placebo in Bronchiectasis, sponsored by Bayer. Completed at 47 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-12.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.
Safety issues are addressed in the AE section. There is no standardised and unanimously accepted definition of exacerbation in COPD; 4 definitions are widely used: (1) using a combination of 3 cardinal symptoms: increased dyspnea, sputum volume, and sputum purulence; (2) looking at the presence of the following patterns of symptoms during >=2 consecutive days: either 2 or more of 3 major symptoms (increase in dyspnoea, sputum volume and sputum purulence); or any 1 major symptom together with any 1 minor symptom (increase in nasal discharge, wheeze, sore throat, cough or fever); (3) a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD; (4) a complex of respiratory events (i.e. cough, wheezing, dyspnoea or sputum production) lasting >=3 days.
368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.
This study's enrollment of 124 is above the median of 60 across 233 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Exclusion Criteria:
32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Drug: Ciprofloxacin (Cipro, BAYQ3939)
Inhalation of matching placebo twice a day
Drug: Placebo
Inhalation of 32,5mg Ciprofloxacin inhaled twice a day
Inhalation of matching placebo twice a day
Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29).
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
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
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)
Change From Baseline in Forced Vital Capacity (FVC)
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)
Time to Exacerbation With Antibiotic Intervention
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)
Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score
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)
Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS)
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)
Change From Baseline in High Sensitive C-reactive Protein (hsCRP)
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
Change From Baseline in Absolute Neutrophil Count (ANC)
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
24-hour Sputum Volume
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)
24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)
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)
Microbiological Response of Cipro Inhale Per Participant
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)
Microbiological Response of Cipro Inhale Per Pathogen
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)
Emergence of New Potential Respiratory Pathogens
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)
Emergence of Resistance Among Baseline Pathogens
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)
Change From Baseline in Total Bacterial Load in the Sputum
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)
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.
| Milestone | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| Started | 60 | 64 |
| Completed | 39 | 35 |
| Not completed | 21 | 29 |
| Withdrew: Adverse event | 19 | 23 |
| Withdrew: Protocol violation | 1 | 5 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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
| log10 of CFU per gram sputum | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). | -2.94 ± 3.40 | -0.32 ± 2.29 |
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).
| Percent of predicted FEV1 | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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 |
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).
| Percent of predicted FVC | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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 |
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.
| Days | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| Time to Exacerbation With Antibiotic Intervention | NA (NA to NA) | NA (NA to NA) |
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.
| Scores on a scale | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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 |
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.
| Total score on a scale | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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 |
High sensitive C-reactive protein (hsCRP) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.
| mg/L | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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) |
Absolute neutrophil count (ANC) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available.
| giga/L | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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 |
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.
| mL | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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 |
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.
| Percentage of participants | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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 |
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.
| Percentage of participants | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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 |
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
| Participants | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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 |
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).
| Cumulative participants | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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 |
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.
| Participants | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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 |
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
| log10 of CFU per gram sputum | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| 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 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ciprofloxacin Inhale (BAYQ3939) | — | 4/60 (6.7%) | 38/60 (63.3%) |
| Placebo | — | 6/64 (9.4%) | 36/64 (56.3%) |
| Event | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| BronchiectasisInfections and infestations | 1/60 | 5/64 |
| Oesophageal adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/60 | 0/64 |
| Complex regional pain syndromeNervous system disorders | 1/60 | 0/64 |
| HallucinationPsychiatric disorders | 1/60 | 0/64 |
| NeutropeniaBlood and lymphatic system disorders | 0/60 | 1/64 |
| SepsisInfections and infestations | 0/60 | 1/64 |
| Catheterisation cardiacInvestigations | 0/60 | 1/64 |
| Renal impairmentRenal and urinary disorders | 0/60 | 1/64 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 0/60 | 1/64 |
| Event | Ciprofloxacin Inhale (BAYQ3939) | Placebo |
|---|---|---|
| BronchiectasisInfections and infestations | 22/60 | 22/64 |
| Product taste abnormalGeneral disorders | 8/60 | 7/64 |
| HeadacheNervous system disorders | 6/60 | 6/64 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/60 | 5/64 |
| DysgeusiaNervous system disorders | 4/60 | 1/64 |
| DiarrhoeaGastrointestinal disorders | 3/60 | 2/64 |
| NauseaGastrointestinal disorders | 3/60 | 0/64 |
| BronchospasmRespiratory, thoracic and mediastinal disorders | 3/60 | 3/64 |
| Age, Continuous(Years) | Ciprofloxacin Inhale (BAYQ3939) | Placebo | Total |
|---|---|---|---|
| Mean | 64.7 ± 11.8 | 61.4 ± 11.9 | 63.0 ± 11.9 |
| Sex: Female, Male(Participants) | Ciprofloxacin Inhale (BAYQ3939) | Placebo | Total |
|---|---|---|---|
| Female | 39 | 43 | 82 |
| Male | 21 | 21 | 42 |
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