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Trial · NCT03953300

Registered outcomes38

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsiesFrom baseline to Week 48 (Visit 10)The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
PrimaryThe change in airway wall area percentage as the overall median for airway generations 3 and 4 combined as measured by quantitative computed tomography (QCT) imagingFrom baseline to Week 48 (Visit 10)The change in airway wall area percentage as the overall median for airway generations 3 and 4 combined as measured by quantitative computed tomography (QCT) imaging
SecondaryThe change in eosinophil numbers, expressed as number/mm2 in epithelium as measured by major basic protein (MBP) staining in endobronchial biopsiesFrom baseline to Week 48 (Visit 10)The change in eosinophil numbers, expressed as number/mm2 in epithelium as measured by major basic protein (MBP) staining in endobronchial biopsies
SecondaryThe change in eosinophil numbers, expressed as number/mm2 in epithelium and submucosa as measured by major basic protein (MBP) staining in endobronchial biopsiesFrom baseline to Week 48 (Visit 10)The change in eosinophil numbers, expressed as number/mm2 in epithelium and submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies
SecondaryAbsolute change in air trapping of the lung with expiratory density less than -856 Hounsfield Units (HU), and as expiratory-to-inspiratory ratio of mean lung density on computed tomography (CT) scansFrom baseline to Week 48 (Visit 10)Absolute change in air trapping of the lung with expiratory density less than -856 Hounsfield Units (HU), and as expiratory-to-inspiratory ratio of mean lung density on computed tomography (CT) scans
SecondaryAbsolute change in air trapping/small airway obstruction derived from regional matching of the inspiratory/expiratory computed tomography (CT) scansFrom baseline to Week 48 (Visit 10)Absolute change in air trapping/small airway obstruction derived from regional matching of the inspiratory/expiratory computed tomography (CT) scans
SecondaryChange in airway lumen volume and airway resistance as measured by quantitative computed tomography (QCT)From baseline to Week 48 (Visit 10)Change in airway lumen volume and airway resistance as measured by quantitative computed tomography (QCT)
SecondaryChange in endobronchial biopsies on airway epithelial cell integrityFrom baseline to Week 48 (Visit 10)Change in endobronchial biopsies on airway epithelial cell integrity
SecondaryChange in endobronchial biopsies on reticular basement membrane (RBM) thickeningFrom baseline to Week 48 (Visit 10)Change in endobronchial biopsies on reticular basement membrane (RBM) thickening
SecondaryChange in endobronchial biopsies on vascularization of the sub-mucosaFrom baseline to Week 48 (Visit 10)Change in endobronchial biopsies on vascularization of the sub-mucosa
SecondaryAssessments of peripheral airway resistance measured by AOFrom baseline to Week 48 (Visit 10)Assessments of peripheral airway resistance measured by AO
SecondaryChange in endobronchial biopsies on mucin 5AC, oligomeric mucus/gel-forming (MUC5AC)From baseline to Week 48 (Visit 10)Change in endobronchial biopsies on mucin 5AC, oligomeric mucus/gel-forming (MUC5AC)
Secondary
Absolute change in R5-R20 (peripheral airway resistance defined as the difference in resistance between 5 Hz [R5, total respiratory system resistance] and 20 Hz [R20, central resistance]) as measured by airwave oscillometry (AO)
From baseline to Week 48 (Visit 10)
Absolute change in R5-R20 (peripheral airway resistance defined as the difference in resistance between 5 Hz \[R5, total respiratory system resistance\] and 20 Hz \[R20, central resistance\]) as measured by airwave oscillometry (AO)
SecondaryAbsolute change in area under the reactance curve (AX) as measured by airwave oscillometry (AO)From baseline to Week 48 (Visit 10)Absolute change in area under the reactance curve (AX) as measured by airwave oscillometry (AO)
SecondaryAbsolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV)From baseline to Week 48 (Visit 10)Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume (RV)
SecondaryAbsolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC)From baseline to Week 48 (Visit 10)Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) total lung capacity (TLC)
SecondaryAbsolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC)From baseline to Week 48 (Visit 10)Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) inspiratory capacity (IC)
SecondaryAbsolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) RV/TLC ratioFrom baseline to Week 48 (Visit 10)Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) residual volume / total lung capacity (RV/TLC) ratio
SecondaryAbsolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC)From baseline to Week 48 (Visit 10)Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP)functional residual capacity (FRC)
SecondaryAbsolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC)From baseline to Week 48 (Visit 10)Absolute change in pre-bronchodilator (BD) whole body plethysmogrpahy (WBP) vital capacity (VC)

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.

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