Trial · NCT00930982
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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 |
| SECONDARY | Microbiological Response of Cipro Inhale Per Participant | 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 |
| SECONDARY | Microbiological Response of Cipro Inhale Per Pathogen | 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. | Participants | NUMBER |
| SECONDARY | Emergence of New Potential Respiratory Pathogens | 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. | Cumulative participants | NUMBER |
| SECONDARY | Emergence of Resistance Among Baseline Pathogens | 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. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in Total Bacterial Load in the Sputum | 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. Decadic logarithm of colony forming units (CFUs) per gram sputum | log10 of CFU per gram sputum | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT00930982/outcomes