RecruitingNot ApplicableNCT06317909

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


Sponsor

Fraunhofer-Institute of Toxicology and Experimental Medicine

Enrollment

15 participants

Start Date

Aug 9, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study develops and tests new non-invasive ways to measure airway inflammation in people with mild allergic asthma. Participants are exposed to a controlled dose of allergen in a clinic to trigger a mild asthma response, and then researchers test various breath and exhaled air measurements to see how well they track inflammation. **You may be eligible if...** - You are between 18 and 65 years old - You have mild allergic asthma - You are a non-smoker or former smoker who quit at least 1 year ago - You are in generally good health aside from asthma - Women must not be pregnant and must use effective contraception if of childbearing age **You may NOT be eligible if...** - You have moderate or severe asthma or have been hospitalized for asthma in the past year - You have other significant lung diseases - You have used inhaled or oral corticosteroids recently - You are pregnant, nursing, or planning pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERallergen 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

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NCT06317909