Trial · NCT05847452
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The change in the number of inflammatory cells in patients with severe eosinophilic asthma at baseline and after 12 weeks of benralizumab treatment. | 12 weeks | To investigate the changes in the number of inflammatory cells in patients with severe eosinophilic asthma at baseline and after 12 weeks of benralizumab treatment. |
| Primary | The change in the activation status of Type-2 related cells in patients with severe eosinophilic asthma at baseline and after 12 weeks of benralizumab treatment. | 12 weeks | Activation status will be measured by the relative expression of Type 2 inflammatory cells and gene expression |
| Secondary | To investigate changes in epithelial barrier integrity using transepithelial resistance before and after completing treatment with 12 weeks of benralizumab. | 12 weeks | Transepithelial resistance measures changes in voltage across epithelial cells |
| Secondary | To investigate changes in epithelial antiviral responses in untreated vs respiratory virus-infected cells including rhinovirus-16 in epithelial cells collected before and after completing 12 weeks of treatment. | 12 weeks | Gene expression will be measured using RNA sequencing and reported as gene counts |
| Secondary | To investigate changes in antiviral responses of alveolar macrophages to respiratory viruses including rhinovirus-16 in cells collected from the airways before and after completing 12 weeks of treatment. | 12 weeks | To investigate changes in antiviral responses of alveolar macrophages to respiratory viruses including rhinovirus-16 in cells collected from the airways before and after completing 12 weeks of treatment using protein and nucleic acid analyses. |
| Secondary | To investigate changes in epithelial responses to pro-inflammatory cytokines/chemokines in cells collected before and after treatment. | 12 weeks | To investigate changes in epithelial responses to pro-inflammatory cytokines/chemokines in cells collected at baseline and after treatment. |
| Secondary | To investigate changes in Type 2 inflammation in peripheral airways by collecting bronchoalveolar lavage fluid before and after treatment for nucleic acid and protein analyses. | 12 weeks | Change in the cellular proportions of Type 2 inflammatory cells will be measured using RNA sequencing and reported as gene counts |
| Secondary | To investigate changes in peripheral airway dysfunction before and after treatment by measuring impulse oscillometry. | 12 weeks | Impulse oscillometry will be measured as resistance and impedance |
| Secondary | To investigate the change in FeNO levels before and after treatment. | 12 weeks | FeNO will be measured in parts per billion (ppb) |
| Secondary | Change in routine full blood counts including eosinophil and basophil numbers. | Regular timepoints during 12 weeks | Change in routine full blood counts including eosinophil and basophil numbers at baseline and following 12 weeks of treatment. |
| Secondary | Asthma control measured by Asthma Control Questionnaire (ACQ)-6 | 12 weeks | Asthma control questionnaire completed at baseline and following 12 weeks of treatment. Total score ranges from 0-6, with 0=no impairment due to asthma, 6 = maximum impairment due to asthma. |
| Secondary | Quality of Life Score measured by the mini Asthma Quality of Life Questionnaire (mAQLQ) | 12 weeks | Change in mAQLQ score at baseline and following 12 weeks of treatment. Score for each question ranges from 0-7, with 0 = totally limited, 7 = not limited at all. The score is calculated as an average for each domain, with a clinically minimum difference of 0.5. |
| Secondary | Change in lung function parameters measured by spirometry (FEV1, FVC, FEV1/FVC) | 12 weeks | Change in lung function parameters at baseline and after 12 weeks of treatment measured by spirometry (FEV1, FVC, FEV1/FVC) |
| Secondary | Change in the number of airway immune cells and their activation status as well as spatial location in endobronchial biopsies as measured by immunohistochemistry and spatial transcriptomic methods. | 12 weeks | Change in the number of airway immune cells and their activation status as well as spatial location in endobronchial biopsies as measured by immunohistochemistry and spatial transcriptomic methods. |
| Secondary | Change in airway remodelling by assessing structural cells (such as fibroblasts and smooth muscle) using immunostaining and histological examination | 12 weeks | Change in airway remodelling by assessing structural cells (such as fibroblasts and smooth muscle) using immunostaining and histological examination |
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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