A Phase 3 interventional study of Tezepelumab in Asthma and Chronic Rhinosinusitis With Nasal Polyps, sponsored by Dr. Andrew Thamboo, MD. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Dr. Andrew Thamboo, MD · Phase 3, Interventional, and Treatment
The study explores how chronic rhinosinusitis (CRS) and asthma share a common inflammatory process, particularly affecting patients with both conditions. Interaction between immune cells (Interleukins) and Th2 cytokines, such as TSLP, exacerbates asthma control in CRS patients, especially those with nasal polyps (CRSwNP). TSLP plays a pivotal role in initiating and maintaining airway inflammation in both diseases. Tezepelumab, a biologic therapy targeting TSLP, shows promise in reducing inflammation markers in severe asthma but its impact on CRSwNP and quality of life remains unclear. The study proposes investigating Tezepelumab's efficacy in treating CRSwNP and severe asthma to inform future biologic therapies.
The investigators hypothesize that TSLP blockade with Tezepelumab will a) reduce upper airway inflammation based on histological, inflammatory, and remodeling biomarkers, that are evident in the airway remodeling process and b) correlate to a positive clinical response. Thus, nasal samples from chronic rhinosinusitis with nasal polyps (CRSwNP) patients with Severe Asthma (SA) pre- and post-treatment will exhibit inflammatory biomarkers and histopathological evidence that could prove responsive to the Tezepelumab.
The overall research objectives are to evaluate the effect of study intervention (Tezepelumab) on CRSwNP-SA outcomes through a) evaluating the sinonasal inflammatory profile, histopathological features, and remodeling biomarkers and b) investigating the impact of Tezepelumab on the CRSwNP-related clinical outcomes in the treated study subjects.
4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.
This study's planned enrollment of 10 is below the median of 83 across 2,814 interventional studies indexed under Asthma.
Browse Asthma studies →Dr. Andrew Thamboo, MD is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Having CRSwNP based on clinical symptoms and/or radiographic or endoscopic evidence of inflammation in their upper airways (Diagnosis consistent with EPOS 2020)(2)and severe asthma:
Exclusion Criteria:
Have an acute or chronic infection (excluding that related to CRS) requiring managementas follows:
Tezepelumab 210 mg subcutaneous injection every 4 weeks to all 10 participants
Biological: Tezepelumab
10 patients will receive teszpire
Also known as: Teszpire
Eosinophil Count
Measurement of eosinophil count in tissue samples. Cells per high power field (HPF) or cells per millimeter squared (cells/mm²).
Time frame: From baseline to 24 weeks
Neutrophil count
Measurement of neutrophil count in tissue samples. Cells per high power field (HPF) or cells per millimeter squared (cells/mm²).
Time frame: From baseline to 24 weeks.
Basement Membrane Thickness
Measurement of the thickness of the basement membrane in tissue samples. Micrometers (µm)
Time frame: From baseline to 24 weeks
Fibrosis
Assessment of the extent of fibrosis in tissue samples, which may involve scoring systems or quantitative measurements
Time frame: From baseline to 24 weeks
Squamous Metaplasia
Immunohistochemical staining will be used to identify the presence of squamous metaplasia, with scoring based on percentage of positive cells.
Time frame: From baseline to 24 weeks
Lymphocytic Proliferation
Lymphocytic proliferation will be assessed using immunohistochemistry (IHC) to measure the Ki-67 proliferation index in tissue samples, specifically identifying the percentage of Ki-67-positive lymphocytes
Time frame: From baseline to 24 weeks
Immunoglobulin leves
IgE, IgG, IgA,
Time frame: 24 weeks
Th2 Cytokines
Measurement of Th2 cytokines such as IL-4, IL-5, IL-13
Time frame: 24 weeks
Th1/Th17 Cytokines
Measurement of Th1/Th17 cytokines such as IFN-γ and IL-17.
Time frame: 24 weeks
Myeloperoxidase (MPO)
Measurement of MPO levels in sinonasal samples or serum.
Time frame: 24 weeks
Interferon-γ (IFN-γ)
Measurement of IFN-γ levels in sinonasal samples or serum.
Time frame: 24 weeks
SNOT-22 (Sino-Nasal Outcome Test 22-item)
Assessment of sinonasal symptoms and their impact on quality of life using a 22-item questionnaire.
Time frame: 24 weeks
Health-Related Quality of Life
Measurement of health-related quality of life using the EuroQualityOfLife 5-Dimension 5-Level (EQ-5D-5L) instrument. The EQ-5D-5L includes 5 dimensions of health (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression) with 5 levels of severity for each dimension (no problems, slight problems, moderate problems, severe problems, and extreme problems). For the overall EQ-5D-5L index score, it typically ranges from: Minimum Value: 0 (representing death) Maximum Value: 1 (representing perfect health) In some versions, a negative score can be obtained, which represents a state "worse than death."
Time frame: 24 weeks
Asthma Control Questionnaire
Asthma control will be assessed using the 5-question Asthma Control Questionnaire (ACQ-5), which includes the following domains: symptoms, reliever medication use, and limitations on daily activities. Each question is rated on a scale from 0 (no symptoms) to 6 (maximum symptoms). The total score is the sum of the individual responses, with possible scores ranging from 0 to 30
Time frame: 24 weeks
Epithelial Changes
Measurement of epithelial changes in sinonasal tissues, including alterations in epithelial thickness, cell type, and structural modifications.
Time frame: 24 weeks
Modified Lund-Kennedy Endoscopy Score
Evaluation of sinonasal pathology using the Modified Lund-Kennedy endoscopy scoring system, which assesses factors like nasal polyp size, discharge, and mucosal appearance. Typically ranges from 0 to 24, where higher scores indicate more severe disease.
Time frame: 24 weeks
Lund-Mackay CT Scan Score
Evaluation of sinus opacifications and other CT scan findings using the Lund-Mackay scoring system, which assesses the extent of sinus disease. Typically ranges from 0 to 24. 0 (no opacification) to 2 (complete opacification)
Time frame: 24 weeks
Changes in smell
Measurement of changes in olfactory function using the University of Pennsylvania Smell Identification Test (UPSIT)
Time frame: 24 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Mar 2025, 2 months later.
Of 194 phase 3 interventional studies under Asthma, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 42. This study's planned 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tezepelumab
Dr. Andrew Thamboo, MD