| Primary | 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 | 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. | Posted | | Mean | Standard Deviation | log10 of CFU per gram sputum | | Baseline and 29 days | | | | ID | Title | Description |
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| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-2.94± 3.40
- OG001-0.32± 2.29
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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 | ANCOVA | Baseline cfu was covariate, treatment and pooled centers factors. As the p-value for interaction was 0.214, the no-interaction model is appropriate. | < 0.001 | 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. | Difference in Least square means | -2.368 | Standard Error of the Mean | 2.674 | | | | | | | |
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| Secondary | 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). | 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. | Posted | | Mean | Standard Deviation | Percent of predicted FEV1 | | Baseline and up to end of study (planned at Day 84) | | | | ID | Title | Description |
|---|
| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Secondary | 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). | 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. | Posted | | Mean | Standard Deviation | Percent of predicted FVC | | Baseline and up to end of study (planned at Day 84) | | | | ID | Title | Description |
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| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Secondary | 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. | 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 | Posted | | Median | Inter-Quartile Range | Days | | Up to end of study (planned at Day 84) | | | | ID | Title | Description |
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| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | Up to end of study (planned at Day 84) | | | | ID | Title | Description |
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| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | Total score on a scale | | Up to end of study (planned at Day 84) | | | | ID | Title | Description |
|---|
| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Secondary | 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. | 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. | Posted | | Median | Inter-Quartile Range | mg/L | | Baseline and up to Day 42 | | | | ID | Title | Description |
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| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | giga/L | | Baseline and up to Day 42 | | | | ID | Title | Description |
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| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | mL | | Up to end of study (planned at Day 84) | | | | ID | Title | Description |
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| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Secondary | 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. | 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. | Posted | | Number | | Percentage of participants | | Up to end of study (planned at Day 84) | | | | ID | Title | Description |
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| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Secondary | 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. | 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. | Posted | | Number | | Percentage of participants | | Up to end of study (planned at Day 84) | | | | ID | Title | Description |
|---|
| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Secondary | 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 | 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. | Posted | | Number | | Participants | | Up to end of study (planned at Day 84) | | | | ID | Title | Description |
|---|
| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Secondary | 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). | 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. | Posted | | Number | | Cumulative participants | | Up to end of study (planned at Day 84) | | | | ID | Title | Description |
|---|
| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Secondary | 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. | 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. | Posted | | Number | | Participants | | Up to end of study (planned at Day 84) | | | | ID | Title | Description |
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| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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| Other Pre-specified | 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 | 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 | Posted | | Mean | Standard Deviation | log10 of CFU per gram sputum | | Baseline and up to end of study (planned at Day 84) | | | | ID | Title | Description |
|---|
| OG000 | Ciprofloxacin Inhale (BAYQ3939) | 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily | | OG001 | Placebo | Inhalation of matching placebo twice a day |
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