Trial · NCT01764841
Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
NCT01764841, Phase 3, Completed, Bayer; results first posted 2017-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE). Trials, record NCT01764841. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01764841
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
- NCT number
- NCT01764841
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 416 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Bronchiectasis
- Interventions
- Ciprofloxacin DPI (BAYQ3939), Placebo
- First posted
- 2013-01-10
- Last updated
- 2018-01-24
- Other registries' IDs
- eudract:2011-004208-39
- Results first posted
- 2017-05-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Exacerbation Event Within 48 Weeks | Up to Week 48 | 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. |
| Secondary | Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks | Up to Week 48 | 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. |
| Secondary | Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks | Up to Week 48 | 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. |
| Secondary | Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46) | End of treatment (Week 44/46) | 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. |
| Secondary | Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46) | Baseline and end of treatment (Week 44/46) | 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. |
| Secondary | Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46) | End of treatment (Week 44/46) | 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. |
| Secondary | 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) | Baseline and end of treatment (Week 44/46) | 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. |
| Secondary | Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46) | Baseline and end of treatment (Week 44/46) | 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). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Exacerbation Event Within 48 Weeks | Up to Week 48 | Full analysis set (FAS) included participants who were randomized. | Days | MEDIAN |
| SECONDARY | Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks | Up to Week 48 | Full analysis set (FAS) included participants who were randomized. | Participants | NUMBER |
| SECONDARY | Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks | Up to Week 48 | Full analysis set (FAS) included participants who were randomized. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46) | End of treatment (Week 44/46) | Full analysis set (FAS) included participants who were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46) | Baseline and end of treatment (Week 44/46) | FAS with participants evaluable for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46) | End of treatment (Week 44/46) | Full analysis set (FAS) included participants who were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | 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) | Baseline and end of treatment (Week 44/46) | FAS with participants evaluable for this outcome measure. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46) | Baseline and end of treatment (Week 44/46) | FAS with participants evaluable for this outcome measure. | Liter | MEAN |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Exacerbation Event Within 48 Weeks | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | 336 | 97.5% Confidence Interval 206 to NA | Days | |
| Time to First Exacerbation Event Within 48 Weeks | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | NA | 97.5% Confidence Interval 290 to NA | Days | |
| Time to First Exacerbation Event Within 48 Weeks | Pooled Placebo | 186 | 97.5% Confidence Interval 136 to 282 | Days | |
| Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | Number of exacerbations: 0 | 66 | Participants | |
| Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | Number of exacerbations: 0 | 72 | Participants | |
| Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks | Pooled Placebo | Number of exacerbations: 0 | 44 | Participants | |
| Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | Number of exacerbations: 1 | 44 | Participants | |
| Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | Number of exacerbations: 1 | 38 | Participants | |
| Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks | Pooled Placebo | Number of exacerbations: 1 | 58 | Participants | |
| Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | Number of exacerbations: 2 | 12 | Participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | 141 | |
| Overall Study | STARTED | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | 137 | |
| Overall Study | STARTED | Placebo 28 Days on/Off (Placebo 28) | 70 | |
| Overall Study | STARTED | Placebo 14 Days on/Off (Placebo 14) | 68 | |
| Overall Study | Participants Received Treatment | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | 141 | |
| Overall Study | Participants Received Treatment | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | 136 | |
| Overall Study | Participants Received Treatment | Placebo 28 Days on/Off (Placebo 28) | 69 | |
| Overall Study | Participants Received Treatment | Placebo 14 Days on/Off (Placebo 14) | 68 | |
| Overall Study | COMPLETED | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | 118 | |
| Overall Study | COMPLETED | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | 111 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events258
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 DPI 28 Days on/Off (Cipro 28) | 7 | 141 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | 9 | 136 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Pooled Placebo | 5 | 137 | 5 |
| other | Nausea | Gastrointestinal disorders | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | 5 | 141 | 5 |
| other | Nausea | Gastrointestinal disorders | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | 10 | 136 | 11 |
| other | Nausea | Gastrointestinal disorders | Pooled Placebo | 7 | 137 | 7 |
| other | Chest pain | General disorders | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | 5 | 141 | 5 |
| other | Chest pain | General disorders | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | 7 | 136 | 8 |
| other | Chest pain | General disorders | Pooled Placebo | 7 | 137 | 7 |
| other | Fatigue | General disorders | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | 6 | 141 | 6 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | ||
| Total, all-cause mortality | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | ||
| Total, all-cause mortality | Pooled Placebo | ||
| Total, other adverse events | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | 74 | 141 |
| Total, other adverse events | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | 83 | 136 |
| Total, other adverse events | Pooled Placebo | 62 | 137 |
| Total, serious adverse events | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | 29 | 141 |
| Total, serious adverse events | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | 23 | 136 |
| Total, serious adverse events | Pooled Placebo | 32 | 137 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01764841
GET https://conductscience.org/api/trials/v1/NCT01764841/results?page=2