Health TrialsbyHealthPanel

Opening the "Black Box" on Tezepelumab's Effect on Chronic Rhinosinusitis With Severe Asthma

ConditionsAsthmaChronic Rhinosinusitis With Nasal Polyps
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorDr. Andrew Thamboo, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Must be ≥19 of age at the time of signing the informed consent form

Capable of giving signed informed consent.

SA based on GINA criteria (37) and confirmed with spirometry and assessmenton the previous history of asthma (a pre-post bronchodilator spirometry ormethacholine challenge to document the positive or negative history of asthmawill be performed if there is no clinical record).

Nasal polyp score (NPS) of at least 2 on each side

Disqualifiers

Have previously undergone sinus surgery or nasal polypectomy

A history of organ transplantation such as lung transplantation

Previously or currently using immunomodulator medications or antihistamines

A history of auto-immune diseases

Trial design

Design model

Single group

Treatments tested in this trial

  • Tezepelumab

    Biological/Vaccine

    10 patients will receive teszpire

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: TezepelumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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.
3

Basement Membrane Thickness

Measurement of the thickness of the basement membrane in tissue samples. Micrometers (µm)

Time frame
From baseline to 24 weeks
4

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

Secondary outcomes

1

Immunoglobulin leves

IgE, IgG, IgA,

Time frame
24 weeks
2

Th2 Cytokines

Measurement of Th2 cytokines such as IL-4, IL-5, IL-13

Time frame
24 weeks
3

Th1/Th17 Cytokines

Measurement of Th1/Th17 cytokines such as IFN-γ and IL-17.

Time frame
24 weeks
4

Myeloperoxidase (MPO)

Measurement of MPO levels in sinonasal samples or serum.

Time frame
24 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Andrew Thamboo, MD

Lead sponsor

St. Paul's Sinus Centre

Sponsor institution

AstraZeneca

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: