Trial · NCT00930982
Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
NCT00930982, Phase 2, Completed, Bayer; results first posted 2012-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis. Trials, record NCT00930982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00930982
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
- NCT number
- NCT00930982
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Bronchiectasis
- Interventions
- Ciprofloxacin (Cipro, BAYQ3939), Placebo
- First posted
- 2009-07-02
- Last updated
- 2014-12-12
- Other registries' IDs
- eudract:2009-009869-34
- Results first posted
- 2012-01-30
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). | Baseline and 29 days | 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 |
| Secondary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline and up to end of study (planned at Day 84) | 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). |
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) | Baseline and up to end of study (planned at Day 84) | 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). |
| Secondary | Time to Exacerbation With Antibiotic Intervention | Up to end of study (planned at Day 84) | 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. |
| 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 | Up to end of study (planned at Day 84) | 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. |
| Secondary | Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS) | Up to end of study (planned at Day 84) | 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. |
| Secondary | Change From Baseline in High Sensitive C-reactive Protein (hsCRP) | Baseline and up to Day 42 | High sensitive C-reactive protein (hsCRP) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available. |
| Secondary | Change From Baseline in Absolute Neutrophil Count (ANC) | Baseline and up to Day 42 | Absolute neutrophil count (ANC) was determined from safety blood samples. Missing or invalid values were replaced with the last valid value available. |
| Secondary | 24-hour Sputum Volume | Up to end of study (planned at Day 84) | 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. |
| Secondary | 24-hour Sputum Color (Percentage of Participants With Non-clear Sputum) | Up to end of study (planned at Day 84) | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). | Baseline and 29 days | 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. | log10 of CFU per gram sputum | MEAN |
| SECONDARY | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline and up to end of study (planned at Day 84) | 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. | Percent of predicted FEV1 | MEAN |
| SECONDARY | Change From Baseline in Forced Vital Capacity (FVC) | Baseline and up to end of study (planned at Day 84) | 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. | Percent of predicted FVC | MEAN |
| SECONDARY | Time to Exacerbation With Antibiotic Intervention | Up to end of study (planned at Day 84) | 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 | Days | MEDIAN |
| 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 | Up to end of study (planned at Day 84) | 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. | Scores on a scale | MEAN |
| SECONDARY | Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS) | Up to end of study (planned at Day 84) | 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. | Total score on a scale | MEAN |
| SECONDARY | Change From Baseline in High Sensitive C-reactive Protein (hsCRP) | Baseline and up to Day 42 | 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. | mg/L | MEDIAN |
| SECONDARY | Change From Baseline in Absolute Neutrophil Count (ANC) | Baseline and up to Day 42 | 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. | giga/L | MEAN |
| SECONDARY | 24-hour Sputum Volume | Up to end of study (planned at Day 84) | 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. | mL | MEAN |
| SECONDARY | 24-hour Sputum Color (Percentage of Participants With Non-clear Sputum) | Up to end of study (planned at Day 84) | 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. | Percentage of participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group312
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). | Ciprofloxacin Inhale (BAYQ3939) | -2.94 | Standard Deviation 3.40 | log10 of CFU per gram sputum | |
| Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29). | Placebo | -0.32 | Standard Deviation 2.29 | log10 of CFU per gram sputum | |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Ciprofloxacin Inhale (BAYQ3939) | Day 8 | -0.67 | Standard Deviation 4.50 | Percent of predicted FEV1 |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Placebo | Day 8 | -0.14 | Standard Deviation 5.10 | Percent of predicted FEV1 |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Ciprofloxacin Inhale (BAYQ3939) | Day 29 | -0.53 | Standard Deviation 7.88 | Percent of predicted FEV1 |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Placebo | Day 29 | -0.22 | Standard Deviation 9.57 | Percent of predicted FEV1 |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Ciprofloxacin Inhale (BAYQ3939) | Day 42 | 1.19 | Standard Deviation 5.88 | Percent of predicted FEV1 |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Placebo | Day 42 | -0.26 | Standard Deviation 9.88 | Percent of predicted FEV1 |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Ciprofloxacin Inhale (BAYQ3939) | Day 56 | 0.81 | Standard Deviation 5.50 | Percent of predicted FEV1 |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Placebo | Day 56 | -0.24 | Standard Deviation 9.61 | Percent of predicted FEV1 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ciprofloxacin Inhale (BAYQ3939) | 60 | |
| Overall Study | STARTED | Placebo | 64 | |
| Overall Study | COMPLETED | Ciprofloxacin Inhale (BAYQ3939) | 39 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | Ciprofloxacin Inhale (BAYQ3939) | 21 | |
| Overall Study | NOT COMPLETED | Placebo | 29 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Ciprofloxacin Inhale (BAYQ3939) | 3 | 60 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 64 | 2 |
| other | Nausea | Gastrointestinal disorders | Ciprofloxacin Inhale (BAYQ3939) | 3 | 60 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 64 | 0 |
| other | Product taste abnormal | General disorders | Ciprofloxacin Inhale (BAYQ3939) | 8 | 60 | 8 |
| other | Product taste abnormal | General disorders | Placebo | 7 | 64 | 7 |
| other | Bronchiectasis | Infections and infestations | Ciprofloxacin Inhale (BAYQ3939) | 22 | 60 | 24 |
| other | Bronchiectasis | Infections and infestations | Placebo | 22 | 64 | 23 |
| other | Dysgeusia | Nervous system disorders | Ciprofloxacin Inhale (BAYQ3939) | 4 | 60 | 4 |
| other | Dysgeusia | Nervous system disorders | Placebo | 1 | 64 | 1 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ciprofloxacin Inhale (BAYQ3939) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ciprofloxacin Inhale (BAYQ3939) | 38 | 60 |
| Total, other adverse events | Placebo | 36 | 64 |
| Total, serious adverse events | Ciprofloxacin Inhale (BAYQ3939) | 4 | 60 |
| Total, serious adverse events | Placebo | 6 | 64 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23018904 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ciprofloxacin Inhale (BAYQ3939) vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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