Trial · NCT04396366
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline In Bacterial Load Colony-forming Units of Potentially Pathogenic Microorganisms in Sputum at Week 12 | Baseline, 12 weeks | This measure reflects the amount of bacteria present in a patient's lungs. |
| Secondary | Number of Participants With Absence of Any Colony-forming Units of Potentially Pathogenic Bacteria Sputum | Baseline, 12 weeks | |
| Secondary | Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B) (Respiratory Symptoms Domain) | Baseline, Days 28, 56, 84 | The Quality of Life Questionnaire for Bronchiectasis (QOL-B) is 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 is scored separately on a scale of 0 to 100, and higher scores represent better outcomes. Only the respiratory symptoms domain score is reported for this outcome measure. |
| Secondary | Change From Baseline in Fibrinogen Plasma Concentration | Baseline, 12 weeks | |
| Secondary | Change From Baseline in Daily Rescue Medication Use (Salbutamol/Albuterol) | Baseline, 12 weeks | The total number of puffs of rescue medication was divided by the total number of (full or half) days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient for the given visit interval. |
| Secondary | Change From Baseline in Pre-bronchodilator Forced Exploratory Volume in the First Second (FEV1) | Baseline, Days 28, 56, 84 | FEV1 is the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation. |
| Secondary | Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC) | Baseline, Days 28, 56, 84 | Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. |
| Secondary | Change From Baseline in Bronchus Region Pi10 | Baseline, 12 weeks | Pi10 is the square root of the wall area for an idealized airway with a luminal perimeter of 10 mm. Pi10 is the most commonly used measure of wall thickening and represents a regional estimate of the small airways across the whole lung or a particular lobe. Measured by high resolution computed tomography (HRCT). |
| Secondary | Change From Baseline in Region Percent Below or Equal to -856 Hounsfield Units (HU) | Baseline, 12 weeks | The region percent below or equal to -856 HU represents air trapping, which was evaluated by HRCT in the whole lung and in the regions (thirds, lobes). |
| Secondary | Change From Baseline in Region Air Volume | Baseline, 12 weeks | Measured by HRCT |
| Secondary | Change From Baseline in Segment Average Inner Area | Baseline, 12 weeks | Measured by HRCT |
| Secondary | Change From Baseline in Segment Average Major Inner Diameter | Baseline, 12 weeks | Measured by HRCT |
| Secondary | Change From Baseline in Segment Average Minor Inner Diameter | Baseline, 12 weeks | Measured by HRCT |
| Secondary | Change From Baseline in Segment Average Outer Area | Baseline, 12 weeks | Measured by HRCT |
| Secondary | Change From Baseline in Segment Average Wall Area Fraction | Baseline, 12 weeks | Wall area fraction or ratio was calculated by dividing the wall area of the corresponding segment to the total airway area. Measured by HRCT. |
| Secondary | Change From Baseline in Segment Average Wall Thickness | Baseline, 12 weeks | Measured by HRCT |
| Secondary | Change From Baseline in Segment Wall Area Percent | Baseline, 12 weeks | Measured by HRCT |
| Secondary | Change From Baseline in Segment Wall Area | Baseline, 12 weeks | Measured by HRCT |
| 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 | Maximum (peak) plasma concentration of QBW251 |
| Secondary | Ctrough of QBW251 | Pre-dose Day 1, Day 28, Day 56, Day 84 | Trough (pre-dose) plasma concentration of QBW251 |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04396366/registered