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RECRUITING
NCT06317909
NA

Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma

Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine

View on ClinicalTrials.gov

Summary

The goal of this exploratory method-development study is to to establish and evaluate novel non-invasive methods to monitor airway inflammation induced by allergen challenge (both by instillation during bronchoscopy and by inhalation) in patients with mild allergic asthma. The investigator wants to further profile and develop the allergen challenge model by investigating the utility of various non-invasive monitoring methods. The hypothesis of the project is that local inflammatory changes in the lung induced by allergen can be captured by gas-enhanced magnetic resonance imaging (MRI) and analysis of exhaled breath. The validation of cellular outcome measures and non-invasive inflammometry can be used in future clinical trials for proof of concept of novel anti-inflammatory medications. Participants will undergo * methacholine challenge * 2 inhaled allergen challenges * 2 MRI with hyperpolarized xenon and gadolinium based contrast agent * 2 bronchoscopies with bronchoalveolar lavage (BAL) * segmental allergen challenge during the first bronchoscopy * spirometry * skin prick test and skin prick dilution tests * measurement of particles in exhaled air * nasal filter * nasal lavage * sputum induction * peak flow meter tests * exhaled NO (nictric oxide) * blood sampling (in total approx. 190 ml)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2024-08-09

Completion Date

2026-09

Last Updated

2025-05-18

Healthy Volunteers

No

Interventions

OTHER

allergen challenge

Patients will undergo inhaled allergen challenge followed by different measures like MRI and induced sputum. At least 4 weeks later patients will undergo segmental allergen challenge followed by different measures like bronchoalveolar lavage.

Locations (1)

Fraunhofer Institute for Toxicology and Experimental Medicine

Hanover, Lower Saxony, Germany