Opening the "Black Box" on Tezepelumab's Effect on Chronic Rhinosinusitis With Severe Asthma
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
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
Treatments tested in this trial
- Tezepelumab
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov