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NCT05365841
Role of Epithelial Barrier Integrity in Biologic Treatment Response of Severe Asthmatics With/Out Chronic Rhinosinusitis With Nasal Polyps (CRSwNP).
trial testing Mepolizumab 100 MG in Severe Eosinophilic Asthma w/wo CRSwNP in 85 participants. Status unknown.
15 May 2025
Quick facts
| Lead sponsor | University of Crete |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 85 |
| Start date | 15 May 2022 |
| Primary completion | 15 May 2025 |
| Estimated completion | 16 November 2025 |
| Sites | 2 locations across Greece |
Drugs / interventions tested
- Mepolizumab 100 MG — full drug profile →
Conditions studied
- Severe Eosinophilic Asthma w/wo CRSwNP — all drugs for Severe Eosinophilic Asthma w/wo CRSwNP →
Sponsor
University of Crete
Who can join
18 and older, any sex, with Severe Eosinophilic Asthma w/wo CRSwNP. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Advances in understanding the pathophysiology of asthma development and severity have pointed towards a prominent role of the bronchial epithelium, especially in more chronic and severe disease. Studies suggest that airway eosinophilic inflammation in asthma is linked to epithelial injury and structural changes of the airways, co called airway wall remodeling. Together the chronic airway inflammation and remodeling are associated with bronchial hyperresponsiveness, fixed airflow obstruction or progressive loss of lung function and clinical severity of asthma. Chronic rhinosinusitis with nasal polyps (CRSwNP), is another respiratory inflammatory disease often co-existing with severe asthma, sharing similar pathophysiology. The investigators hypothesize that epithelial barrier integrity may play a role in the pathophysiology of severe eosinophilic asthma and nasal polyposis and in response to anti-IL5 therapy of severe asthmatics, and that shedding of epithelial barrier proteins may be used as biomarker in the management of severe asthma. In order to study that, the investigators will conduct a prospective cohort study of adult severe asthmatics with/out CRSwNP, who live on the island of Crete, Greece and who meet the criteria for entering anti-IL5 treatment, as assessed by pulmonologist. The participants will be recruited with a convenience sampling in a period of 2 years, under real life conditions, and will be followed up for 1 year after treatment initiation. A control group of subjects diagnosed with nasal polyposis without severe asthma will be used. Eligible subjects will undergo clinical assessment with radiological (CT) and endoscopic investigations. Samples of serum, sputum, nasal secretions, as well as nasal and bronchial biopsies will be obtain for assessing clinicopathological differences among the 3 groups but also response to anti-IL5 therapy in SEA w/o CRSwNP.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT05365841
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05365841 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Crete
- Last refreshed: 18 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05365841.
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