Expression of TSLP Isoforms in Asthma
TSLP and Its Isoforms (Short and Long Form TSLP) in Different Asthma Phenotypes
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:
- 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),
- 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.
- 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Izabela Orzołek, MD
- Número de teléfono: +48516223281
- Correo electrónico: izabela.orzolek@wum.edu.pl
Ubicaciones de estudio
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Warsaw
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Warsaw, Warsaw, Polonia, 02-097
- Reclutamiento
- Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw, Warsaw, Poland,
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Contacto:
- Izabela Orzołek, MD
- Número de teléfono: +48225991000
- Correo electrónico: kpa.csk@uckwum.pl
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Investigador principal:
- Marta Dąbrowska, MD, PhD, Associate Professor
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Sub-Investigador:
- Izabela Orzołek, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion criteria
- age > 18 years, without the upper age limit,
- asthma (diagnosis in accordance with the GINA 2023 guidelines),
Exclusion criteria
- other respiratory diseases (e.g., chronic obstructive pulmonary disease [COPD]);
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Study group consists of patients with severe asthma (diagnosed according to GINA guidelines)
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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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Control group
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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TSLP mRNA expression, including the sfTSLP and lfTSLP isoforms in nasal epithelial cells and TSLP protein expression in blood and nasal epithelial cells
Periodo de tiempo: 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
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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
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Medical University of Warsaw
- 31/M/MB/N/24 (Otro número de subvención/financiamiento: Young Scientist Grant, Medical University of Warsaw)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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