An observational study in Asthma Atopic and Asthma Severe Persistent Uncontrolled, sponsored by Medical University of Warsaw. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Medical University of Warsaw · Observational
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:
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 70 is below the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
age > 18 years, without the upper age limit,
other respiratory diseases (e.g., [COPD]);
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: No Intervention: Observational Cohort
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.
Diagnostic Test: No Intervention: Observational Cohort
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.
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
Time frame: 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
Plan to share: Undecided
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