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

NCT06317909 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-05-18

No results posted yet for this study

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)

Conditions

  • Mild Allergic Asthma

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.

Sponsors & Collaborators

  • Fraunhofer-Institute of Toxicology and Experimental Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-09
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06317909 on ClinicalTrials.gov