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TSLP and Its Isoforms (Short and Long Form TSLP) in Different Asthma Phenotypes
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Young Scientist Grant, Medical University of Warsaw
observational
70
1 country
1
Study Start
April 30, 2024
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2024
Actual (reported)January 23, 2026
Actual (reported)August 26, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
TSLP mRNA expression, including the sfTSLP and lfTSLP isoforms in nasal epithelial cells and TSLP protein expression in blood and nasal epithelial cells
The primary endpoint of the study is the quantitative assessment of TSLP protein expression and TSLP mRNA expression, including the sfTSLP and lfTSLP isoforms, in biological material obtained from serum and nasal epithelial cells. Peripheral venous blood samples will be collected and centrifuged to obtain serum, which will be aliquoted and stored at -80°C until analysis. Nasal epithelial cells will be collected using sterile cytology brushes. All biological samples will be processed promptly and stored under appropriate conditions prior to laboratory analysis. TSLP protein concentrations will be measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits in accordance with the manufacturer's instructions. Measurements will be performed in duplicate, and optical density will be determined using a microplate reader. Concent
This is cross-sectional studies; blood and nasal epithelial cells (nasal swab) will be taken from each study participant at one study point - through study completion, an average of 2 years
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.
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.
This study is designed as a cross-sectional, observational investigation. No therapeutic or diagnostic interventions beyond routine clinical care will be introduced as part of the study. All procedures performed are limited to standard, minimally invasive sample collection and data acquisition for research purposes. Clinical management of participants will remain unchanged and will be conducted entirely at the discretion of the treating physicians. Participation in the study will not influence treatment decisions or patient care.
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Patients with severe asthma, 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).
Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw, Warsaw, Poland,
Warsaw, Warsaw, 02-097, Poland
First Submitted
January 23, 2026
First Posted
August 26, 2026
Study Start
April 30, 2024
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 26, 2026
Record last verified: 2026-01
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