Trial · NCT04396366
Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QBW251 in Subjects With Bronchiectasis
NCT04396366, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2025-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QBW251 in Subjects With Bronchiectasis. Trials, record NCT04396366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04396366
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QBW251 in Subjects With Bronchiectasis
- NCT number
- NCT04396366
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Bronchiectasis
- Interventions
- QBW251, Placebo
- First posted
- 2020-05-20
- Last updated
- 2025-09-26
- Results first posted
- 2025-03-06
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
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 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 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group208
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 Bacterial Load Colony-forming Units of Potentially Pathogenic Microorganisms in Sputum at Week 12 | QBW251 300 mg b.i.d | -0.192 | Standard Deviation 1.4621 | CFU/mL | |
| Change From Baseline In Bacterial Load Colony-forming Units of Potentially Pathogenic Microorganisms in Sputum at Week 12 | Placebo | 0.340 | Standard Deviation 1.6476 | CFU/mL | |
| Number of Participants With Absence of Any Colony-forming Units of Potentially Pathogenic Bacteria Sputum | QBW251 300 mg b.i.d | 0 | Participants | ||
| Number of Participants With Absence of Any Colony-forming Units of Potentially Pathogenic Bacteria Sputum | Placebo | 0 | Participants | ||
| Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B) (Respiratory Symptoms Domain) | QBW251 300 mg b.i.d | Day 28 n=12,19 | 5.247 | Standard Deviation 10.9936 | score on a scale |
| Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B) (Respiratory Symptoms Domain) | Placebo | Day 28 n=12,19 | 7.212 | Standard Deviation 9.5209 | score on a scale |
| Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B) (Respiratory Symptoms Domain) | QBW251 300 mg b.i.d | Day 56 n=12,20 | 1.852 | Standard Deviation 5.8026 | score on a scale |
| Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B) (Respiratory Symptoms Domain) | Placebo | Day 56 n=12,20 | 1.852 | Standard Deviation 11.7429 | score on a scale |
| Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B) (Respiratory Symptoms Domain) | QBW251 300 mg b.i.d | Day 84 n=13,20 | 2.849 | Standard Deviation 9.4612 | score on a scale |
| Change From Baseline in Quality of Life Questionnaire for Bronchiectasis (QOL-B) (Respiratory Symptoms Domain) | Placebo | Day 84 n=13,20 | 3.519 | Standard Deviation 11.9848 | score on a scale |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QBW251 300 mg b.i.d | 21 | |
| Overall Study | STARTED | Placebo | 21 | |
| Overall Study | COMPLETED | QBW251 300 mg b.i.d | 20 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | QBW251 300 mg b.i.d | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events42
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 | Gastrooesophageal reflux disease | Gastrointestinal disorders | QBW251 300 mg b.i.d | 0 | 21 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Placebo | 2 | 21 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Total | 2 | 42 | |
| other | Fatigue | General disorders | QBW251 300 mg b.i.d | 3 | 21 | |
| other | Fatigue | General disorders | Placebo | 5 | 21 | |
| other | Fatigue | General disorders | Total | 8 | 42 | |
| other | Peripheral swelling | General disorders | QBW251 300 mg b.i.d | 0 | 21 | |
| other | Peripheral swelling | General disorders | Placebo | 2 | 21 | |
| other | Peripheral swelling | General disorders | Total | 2 | 42 | |
| other | Pyrexia | General disorders | QBW251 300 mg b.i.d | 3 | 21 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QBW251 300 mg b.i.d | 0 | 21 |
| Total, all-cause mortality | Placebo | 0 | 21 |
| Total, all-cause mortality | Total | 0 | 42 |
| Total, other adverse events | QBW251 300 mg b.i.d | 14 | 21 |
| Total, other adverse events | Placebo | 13 | 21 |
| Total, other adverse events | Total | 27 | 42 |
| Total, serious adverse events | QBW251 300 mg b.i.d | 2 | 21 |
| Total, serious adverse events | Placebo | 0 | 21 |
| Total, serious adverse events | Total | 2 | 42 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| QBW251 300 mg b.i.d vs Placebo: Number of Participants With Absence of Any Colony-forming Units of Potentially Pathogenic Bacteria Sputum |
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.
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/NCT04396366
GET https://conductscience.org/api/trials/v1/NCT04396366/registered?page=2