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TSLP and Its Isoforms (Short and Long Form TSLP) in Different Asthma Phenotypes

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Asthma is a heterogeneous disease characterized by chronic airway inflammation, leading to variable airflow obstruction, bronchial hyperresponsiveness, excessive mucus secretion, and, consequently, structural airway remodeling. Asthma is defined by the presence of symptoms such as wheezing, dyspnea, chest tightness, and cough, with variable intensity and frequency. Thymic stromal lymphopoietin (TSLP) is a cytokine produced primarily by epithelial cells in the lungs. Two distinct isoforms of TSLP have been identified: a long form (lfTSLP) and a short form (sfTSLP). The long isoform is induced during inflammatory conditions and promotes a T2-dependent immune response. In contrast, the short isoform is believed to exert homeostatic and anti-inflammatory functions and exhibits antimicrobial properties. Studies have demonstrated an association between elevated serum and airway TSLP levels and increased disease severity, as well as reduced spirometric parameters. However, the literature contains limited data regarding the expression of TSLP isoforms across different asthma phenotypes and their relationship with the degree of disease control. The goal of this study is: 1. To assess the expression of TSLP protein and TSLP mRNA, including its isoforms (sfTSLP and lfTSLP), in serum and in airway-derived samples (nasal epithelial cells), 2. To compare these levels among patients with different asthma phenotypes (allergic and non-allergic asthma; eosinophilic, neutrophilic, and paucigranulocytic asthma; early-onset and late-onset asthma; obesity-associated asthma; cough-variant asthma), as well as between patients with asthma and healthy controls. 3. To analyze the correlations between the expression of TSLP isoforms (sfTSLP and lfTSLP) and asthma severity, level of disease control (as measured by the Asthma Control Questionnaire \[ACQ\]), pulmonary function parameters, blood eosinophil count and other clinical parameters.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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⁃ age \> 18 years, without the upper age limit,

• asthma (diagnosis in accordance with the GINA 2023 guidelines),

Locations
Other Locations
Poland
Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw, Warsaw, Poland,
RECRUITING
Warsaw
Contact Information
Primary
Izabela Orzołek, MD
izabela.orzolek@wum.edu.pl
+48516223281
Time Frame
Start Date: 2024-04-30
Estimated Completion Date: 2026-11
Participants
Target number of participants: 70
Treatments
Study group consists of patients with severe asthma (diagnosed according to GINA guidelines)
1. Inclusion criteria Adults aged 18 years, without the upper age limit, diagnosed with asthma established in accordance with the GINA 2023 guidelines.~2. Exclusion criteria Presence of other concomitant respiratory diseases (e.g., chronic obstructive pulmonary disease \[COPD\]); Current use of systemic glucocorticoids or immunosuppressive therapy, or use within 4 weeks prior to study enrollment; Active cigarette smoking or a smoking history of \>10 pack-years; Active malignancy; Active pulmonary tuberculosis or active respiratory tract infection; Use of antibiotics within 4 weeks prior to study enrollment; Current long-term home oxygen therapy (\>15 hours per day); Current treatment with monoclonal antibody therapies (e.g., omalizumab, mepolizumab, reslizumab, dupilumab, tezepelumab, or other biologics); Pregnancy.
Control group
1. Inclusion criteria Age above 18 years old and without the upper age limit. Negative medical history for asthma and allergic diseases.~2. Exclusion criteria Diagnosed asthma or any other respiratory disease; Atopic dermatitis, allergic rhinitis, or other allergic diseases; Autoimmune diseases; All other exclusion criteria identical to those applied to the asthma patient group.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Warsaw

This content was sourced from clinicaltrials.gov