Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With M… (NCT06317909) | Clinical Trial Compass
RecruitingNot Applicable
Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma
Germany15 participantsStarted 2024-08-09
Plain-language 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)
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Able and willing to give written informed consent.
✓. Male and female subjects aged 18-65 years. Women will be considered for inclusion if they are:
✓. History of mild asthma for at least 12 months prior to the Screening Visit that is well controlled with Short Acting Beta-Adrenergic Stimulator (SABA) only.
✓. Body mass index between 18 and 32 kg/m2
✓. Normal pulmonary function with forced Expiratory Volume in the first second (FEV1) ≥80% of predicted normal and FEV1/Forced Vital Capacity(FVC) ≥70% at Screening Visit. Calculations will be based on Global Lung Function Initiative (GLI) formula. If the participant fails to meet this criterion on the first measurement, spirometry may be repeated twice.
✓. Positive skin prick test (wheal diameter reaction ≥3 mm) for the respective challenge aeroallergen (i.e. tree, weed, grass or house dust mite) at or within 12 months prior to the Screening Visit (if performed and documented at Fraunhofer ITEM).
✓. Positive early and late asthmatic response upon incremental inhaled allergen challenge at or prior to the Screening Visit (if performed and documented at Fraunhofer ITEM).
✓. Production of adequate sputum with ≥1 x 106 total non-squamous cells at or within 12 month prior to the Screening Visit 1 (if not performed and documented at Fraunhofer ITEM).
What they're measuring
1
Exploratory (1. priority) Changes in soluble mediators [i.e. IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, INF-alpha, MMP-9, CXCL1, SP-D, albumin] in Bronchoalveolar lavage (BAL) after segmental allergen challenge
Timeframe: 24 hours after segmental allergen challenge
2
Exploratory (1. priority) Changes in soluble mediators [i.e. IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin] in Sputum after inhalative allergen challenge
Timeframe: 24 hours after segmental allergen challenge
✕. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function or ECG at Screening Visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
✕. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, metabolic disease (asymptomatic Gilbert's syndrome is allowed), endocrine disease (stable and asymptomatic hypothyroidism with or without hormone replacement therapy (HRT) is allowed), or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
✕. Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for pain relief, contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements.
✕. Specific Immunotherapy (SIT) within three years prior to the study.
✕. Intake of systemic or inhaled steroids within 4 weeks before Screening Visit 1a.
✕. Respiratory tract infection (RTI) within 4 weeks before Screening Visit 1a.
✕. Mild to moderate asthma exacerbation within 3 months before Screening Visit 1a.
✕. Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
Timeframe: before, 6 and 24 hours after inhaled allergen challenge