Actively Recruiting
Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma
Led by Fraunhofer-Institute of Toxicology and Experimental Medicine · Updated on 2025-05-18
15
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to give written informed consent
- Male and female subjects aged 18-65 years
- Women not pregnant, not nursing, or using effective contraception if of childbearing potential
- History of mild asthma for at least 12 months, well controlled with short-acting beta-agonist only
- Body mass index between 18 and 32 kg/m2
- Normal lung function: FEV1 ≥80% predicted and FEV1/FVC ≥70% at screening
- Positive skin prick test (wheal diameter ≥3 mm) for relevant aeroallergen within 12 months
- Positive early and late asthmatic response to inhaled allergen challenge prior to screening
- Able to produce adequate sputum sample with ≥1 x 10^6 total non-squamous cells within 12 months
- Nonsmokers or minimal smoking history (<1 pack-year) with at least one year of no smoking
You will not qualify if you...
- Clinically relevant abnormal findings in physical exam, labs, vital signs, lung function, or ECG
- Past or present diseases affecting study outcome or safety (e.g., cardiovascular, malignancy, hepatic, renal, hematological, neurological, metabolic, endocrine, or pulmonary diseases)
- Regular use of prescribed or over-the-counter medications except paracetamol, contraceptives, hormone therapy, or supplements
- Specific immunotherapy within 3 years prior to study
- Use of systemic or inhaled steroids within 4 weeks before screening
- Respiratory tract infection within 4 weeks before screening
- Asthma exacerbation within 3 months before screening
- History of life-threatening asthma episodes
- Suspected hypersensitivity to medications used during bronchoscopy
- Conditions preventing bronchoscopy or allergen challenge
- Conditions preventing MRI (e.g., claustrophobia, pacemaker, contrast agent sensitivity)
- Participation in other clinical trials with investigational drugs within 30 days
- Recent segmental allergen challenge within 3 months
- Blood donation exceeding 400 ml within 60 days before screening
- History of drug or alcohol abuse
- Risk of non-compliance or inability to understand study requirements
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Trial Site Locations
Total: 1 location
1
Fraunhofer Institute for Toxicology and Experimental Medicine
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
Research Team
J
Jens Hohlfeld, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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