Trial · NCT04396366
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline In Bacterial Load Colony-forming Units of Potentially Pathogenic Microorganisms in Sputum at Week 12 | Baseline, 12 weeks | The Pharmacodynamics (PD) Analysis Set included all participants with available PD data at both baseline and at least one post-baseline assessment that were not affected by any protocol deviations. Results are reported for participants with available data. | CFU/mL | MEAN |
| SECONDARY | Number of Participants With Absence of Any Colony-forming Units of Potentially Pathogenic Bacteria Sputum | Baseline, 12 weeks | PD Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B) (Respiratory Symptoms Domain) | Baseline, Days 28, 56, 84 | PD Analysis Set. Results are reported for participants with available data. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Fibrinogen Plasma Concentration | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | g/L | MEAN |
| SECONDARY | Change From Baseline in Daily Rescue Medication Use (Salbutamol/Albuterol) | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | number of puffs | MEAN |
| SECONDARY | Change From Baseline in Pre-bronchodilator Forced Exploratory Volume in the First Second (FEV1) | Baseline, Days 28, 56, 84 | PD Analysis Set. Results are reported for participants with available data. | liters | MEAN |
| SECONDARY | Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC) | Baseline, Days 28, 56, 84 | PD Analysis Set. Results are reported for participants with available data. | liters | MEAN |
| SECONDARY | Change From Baseline in Bronchus Region Pi10 | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | mm | MEAN |
| SECONDARY | Change From Baseline in Region Percent Below or Equal to -856 Hounsfield Units (HU) | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | percent of region | MEAN |
| SECONDARY | Change From Baseline in Region Air Volume | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | liters | MEAN |
| SECONDARY | Change From Baseline in Segment Average Inner Area | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | mm^2 | MEAN |
| SECONDARY | Change From Baseline in Segment Average Major Inner Diameter | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | mm | MEAN |
| SECONDARY | Change From Baseline in Segment Average Minor Inner Diameter | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | mm | MEAN |
| SECONDARY | Change From Baseline in Segment Average Outer Area | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | mm^2 | MEAN |
| SECONDARY | Change From Baseline in Segment Average Wall Area Fraction | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | ratio | MEAN |
| SECONDARY | Change From Baseline in Segment Average Wall Thickness | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | mm | MEAN |
| SECONDARY | Change From Baseline in Segment Wall Area Percent | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | percent | MEAN |
| SECONDARY | Change From Baseline in Segment Wall Area | Baseline, 12 weeks | PD Analysis Set. Results are reported for participants with available data. | mm^2 | MEAN |
| SECONDARY | Cmax of QBW251 | 1h, 2h, 3h, 4h, 6h and 8h post-dose on Days 1 and 28, and 3h post-dose on Day 56 and Day 84 | The pharmacokinetic (PK) analysis set included all participants with at least one available valid PK concentration measurement, who received any dose of QBW251 and had no protocol deviations that affected PK data. PK parameters were only analyzed in the QBW251 arm. | ng/mL | MEAN |
| SECONDARY | Ctrough of QBW251 | Pre-dose Day 1, Day 28, Day 56, Day 84 | The pharmacokinetic (PK) analysis set included all participants with at least one available valid PK concentration measurement, who received any dose of QBW251 and had no protocol deviations that affected PK data. PK parameters were only analyzed in the QBW251 arm. | ng/mL | 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/NCT04396366/outcomes