Mild Allergic AsthmaNCT06317909
Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma
A study testing allergen challenge in people with Mild Allergic Asthma, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Allergic Asthma
- What is being tested?
- allergen challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 9 Aug 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Not pregnant, as confirmed by pregnancy test (see assessment schedule), and not nursing.
- Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarcheal or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the Screening Visit).
- Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence, implants, injectables, combined oral contraceptives, hormonal Intrauterine Devices (IUDs) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- 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.
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- 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).
- Nonsmokers with a history of less than 1 pack year having been nonsmokers for at least one year.
Who cannot join
- 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.
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- 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.
- Suspected hypersensitivity to any ingredients of the medication in line with bronchoscopy (bronchodilators, sedatives and local anesthetics).
- Conditions or factors, which would make the subject unlikely to be able to undergo bronchoscopy or allergen challenge.
- Conditions or factors, which would make the subject unlikely to undergo MRI (e.g. due to claustrophobia, cardiac pacemaker, hypersensitivity to MR i.v. contrast imaging agents).
- Participation in another clinical trial with Investigational Medicinal Product (IMP) 30 days or 5 half-lives, whichever is longer, prior to enrollment.
- Participation in the observation period of a competing study within 30 days prior to Screening.
- Segmental allergen challenge three months prior to bronchoscopy.
- Donation of more than 400 ml of blood the preceding 60 days before screening.
- History of regular drug or alcohol abuse
- Risk of non-compliance with study procedures.
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Fraunhofer Institute for Toxicology and Experimental Medicine
Hanover, Lower Saxony, 30625
Jens M Hohlfeld, jens.hohlfeld@item.fraunhofer.de
About this study
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.
Read more
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)
Read the detailed description
An individual study participation takes about 6 to 8 weeks for the experimental phase not including a screening phase that can add up to 8 weeks. The study consists of 10 visits. All visits take place at Fraunhofer ITEM in Hannover.
During screening an inhaled allergen challenge will be performed to decide about eligibility. During the experimental part another inhaled allergen challenge, 2 magnetic resonance imaging (MRI) and 2 bronchoscopies with segmental allergen challenge will be performed.
Methacholine Challenge:
The methacholine bronchial challenge will be performed in accordance with study sites Standard Operating Procedure (SOP). Methacholine will be used according to the manufacturers' instruction. After an initial saline inhalation as a reference, the percent decrease in Forced Expiratory Volume in the first second (FEV1) after each succeeding concentration of methacholine will be determined until the FEV1 drops to 80% of the reference value. An interpolated PC20 (aerosol concentration of methacholine leading to a 20% fall in the FEV1) will be calculated.
Inhaled allergen challenge:
For the inhaled allergen challenge the allergen most likely to induce allergic airway responses will be selected during the screening period. The allergens used for provocation in this study will be lyophilized allergen extracts of respective allergen (LETI Laboratories) developed and licensed for provocation testing.
The starting concentration of allergen extract to be given by inhalation will be calculated based on the prick dilution test as well as the methacholine challenge in order to obtain the allergen concentration that is predicted to cause a 20% decrease in FEV1 ( PC20).
Bronchoscopies with BAL and segmental allergen challenge:
Bronchoscopy will be performed according to the study sites which is consistent with international recommendations for fiberoptic bronchoscopy. In this clinical investigation, two bronchoscopies will be conducted under identical conditions 24 hours apart. Before instillation of allergen, a baseline lavage will be performed during the first bronchoscopy. . Thereafter, a control challenge will be performed by injecting 10 ml of 37°C sterile 0.9% saline.During the second bronchoscopy after 24 hours, BAL from the two challenged segments will be collected. The allergen used for inhaled provocation will be used for segmental provocation as well.
Magnetic resonance imaging:
MRI will be performed at the Clinical Research Center by the Institute for Radiology using a Siemens Avanto 1.5T scanner. In order to assess local inflammation by proton MRI, various sequences will be applied during the imaging session. In addition, gas-enhanced protocols with hyperpolarized xenon will be applied according to the study sites SOP. For the assessment of pulmonary perfusion, a gadolinium based contrast agent (Gadopentetat - Dimeglumin) will be given iv during each MRI scan. It will be 1/3 of the regular dose for this contrast agent.
- Conditions
- Mild Allergic Asthma
- Being tested
- allergen challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allergen challengeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | It is an exploratory study. All participants will undergo allergen challenge. Receives: Other: allergen challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Quantification of allergic inflammatory response induced by segmental allergen challenge in BAL by analyzing soluble mediators using Meso Scale Discovery (MSD) multiplex assays -> At least, but not limited to Interleukin(IL)-4, IL-5, IL-8, IL-13, IL-33, Thymus-Stroma-Lymphopoietin (TSLP), IL-1, IL-6, Interferon-alpha (INF-alpha), Matrix-Metallopeptidase 9 (MMP-9), Chemokine (C-X-C motif) ligand 1 (CXCL1), Surfactant protein D (SP-D), albumin [pg/ml]
Measured: 24 hours after segmental allergen challenge
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
Quantification of allergic inflammatory response induced by inhalation in sputum by analyzing soluble mediators using MSD multiplex assays -> At least, but not limited to IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin [pg/ml]
Measured: 24 hours after segmental allergen challenge
Exploratory (1. priority) Changes in non-invasive exhaled particles [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]after inhalative allergen challenge
Quantification of allergic inflammatory response induced by inhalation in non-invasive exhaled particles at multiple time-points by analyzing soluble mediators using MSD multiplex assays -> At least, but not limited to IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, INF-alpha, MMP-9, CXCL1, SP-D, albumin [pg/ml]
Measured: before, 3, 6 and 24 hours after inhaled allergen challenge
Exploratory (1. priority) Changes in non-invasive exhaled particles [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]after segmental allergen challenge
Quantification of allergic inflammatory response induced by segmental allergen challenge in non-invasive exhaled particles at multiple time-points by analyzing soluble mediators using MSD multiplex assays -> At least, but not limited to IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, INF-alpha, MMP-9, CXCL1, SP-D, albumin [pg/ml]
Measured: before, 3, 6 and 24 hours after segmental allergen challenge
Exploratory (1. priority) Changes in cell analyzation in BAL [i.e.total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells] after segmental allergen challenge
Quantification of allergic inflammatory response induced by segmental allergen challenge in BAL by analyzing cellularity and functionality using microscopy, flow cytometry and chipcytometry ->At least, but not limited to total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells [×10^6 cells/ml]
Measured: 24 hours after segemental allergen challenge
Exploratory (1. priority) Changes in cell analyzation in Sputum [i.e.total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells] after inhalative allergen challenge
Quantification of allergic inflammatory response induced by inhalation in sputum by analyzing cellularity and functionality using microscopy, flow cytometry and chipcytometry -> At least, but not limited to total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells [×10^6 cells/ml]
Measured: before, 6 and 24 hours after inhaled allergen challenge
Secondary outcomes (4)
Exploratory (2. priority) Detection of Ribonucleic acid (RNA) in exhaled particles
Detection of RNA in exhaled particles ->Verification and quantification of RNA
Measured: before, 3, 6, and 24 hours after allergen challenge
Exploratory (2. priority) Changes in Fractional exhaled nitric oxide (FeNO) after inhalative allergen challenge
Quantification of inflammation in the central airways by FeNO in the kinetic of the allergic response after inhalation challenge -> Measurement of FeNO [ppB] and comparison with induced sputum
Measured: before, 3, 6, and 24 hours after inhaled allergen challenge
Exploratory (2. priority) Changes in FeNO after segmental allergen challenge
Quantification of inflammation in the central airways by FeNO in the kinetic of the allergic response after segmental challenge -> Measurement of FeNO [ppB] and comparison with induced sputum
Measured: before, 3, 6 and 24 hours after segmental allergen challenge
Exploratory (2. priority) Quantification of regional ventilation, perfusion, and diffusion by magnetic resonance imaging (MRI)
Quantification of regional ventilation, perfusion, and diffusion assessed by MRI
-> change from baseline of MRI assessed parameters in relation to inflammatory reaction (eosinophil numbers [×10^6 cells/ml] in sputum and BAL) and pulmonary function (FEV1 and maximal forced expiratory flow (MFEF) of 25 to 75% of Vital Capacity of the lungs (MFEF25-75))
Measured: before and 6 hours after inhaled allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start9 Aug 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Allergic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317909
- Sponsor's protocol ID
- 23-03 DONNER-2
- Status last verified
- Jul 2026
- First submitted
- 11 Jan 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma
- ClinicalTrials.gov ID
- NCT06317909
- Acronym / sponsor ID
- 23-03 DONNER-2
- Conditions
- Mild Allergic Asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
An individual study participation takes about 6 to 8 weeks for the experimental phase not including a screening phase that can add up to 8 weeks. The study consists of 10 visits. All visits take place at Fraunhofer ITEM in Hannover.
During screening an inhaled allergen challenge will be performed to decide about eligibility. During the experimental part another inhaled allergen challenge, 2 magnetic resonance imaging (MRI) and 2 bronchoscopies with segmental allergen challenge will be performed.
Methacholine Challenge:
The methacholine bronchial challenge will be performed in accordance with study sites Standard Operating Procedure (SOP). Methacholine will be used according to the manufacturers' instruction. After an initial saline inhalation as a reference, the percent decrease in Forced Expiratory Volume in the first second (FEV1) after each succeeding concentration of methacholine will be determined until the FEV1 drops to 80% of the reference value. An interpolated PC20 (aerosol concentration of methacholine leading to a 20% fall in the FEV1) will be calculated.
Inhaled allergen challenge:
For the inhaled allergen challenge the allergen most likely to induce allergic airway responses will be selected during the screening period. The allergens used for provocation in this study will be lyophilized allergen extracts of respective allergen (LETI Laboratories) developed and licensed for provocation testing.
The starting concentration of allergen extract to be given by inhalation will be calculated based on the prick dilution test as well as the methacholine challenge in order to obtain the allergen concentration that is predicted to cause a 20% decrease in FEV1 ( PC20).
Bronchoscopies with BAL and segmental allergen challenge:
Bronchoscopy will be performed according to the study sites which is consistent with international recommendations for fiberoptic bronchoscopy. In this clinical investigation, two bronchoscopies will be conducted under identical conditions 24 hours apart. Before instillation of allergen, a baseline lavage will be performed during the first bronchoscopy. . Thereafter, a control challenge will be performed by injecting 10 ml of 37°C sterile 0.9% saline.During the second bronchoscopy after 24 hours, BAL from the two challenged segments will be collected. The allergen used for inhaled provocation will be used for segmental provocation as well.
Magnetic resonance imaging:
MRI will be performed at the Clinical Research Center by the Institute for Radiology using a Siemens Avanto 1.5T scanner. In order to assess local inflammation by proton MRI, various sequences will be applied during the imaging session. In addition, gas-enhanced protocols with hyperpolarized xenon will be applied according to the study sites SOP. For the assessment of pulmonary perfusion, a gadolinium based contrast agent (Gadopentetat - Dimeglumin) will be given iv during each MRI scan. It will be 1/3 of the regular dose for this contrast agent.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Other: allergen challengeIt is an exploratory study. All participants will undergo allergen challenge. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allergen challengePatients 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. | Other | single arm |
Primary outcome
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
Time frame: 24 hours after segmental allergen challenge
Quantification of allergic inflammatory response induced by segmental allergen challenge in BAL by analyzing soluble mediators using Meso Scale Discovery (MSD) multiplex assays -> At least, but not limited to Interleukin(IL)-4, IL-5, IL-8, IL-13, IL-33, Thymus-Stroma-Lymphopoietin (TSLP), IL-1, IL-6, Interferon-alpha (INF-alpha), Matrix-Metallopeptidase 9 (MMP-9), Chemokine (C-X-C motif) ligand 1 (CXCL1), Surfactant protein D (SP-D), albumin [pg/ml]
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
Time frame: 24 hours after segmental allergen challenge
Quantification of allergic inflammatory response induced by inhalation in sputum by analyzing soluble mediators using MSD multiplex assays -> At least, but not limited to IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin [pg/ml]
Exploratory (1. priority) Changes in non-invasive exhaled particles [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]after inhalative allergen challenge
Time frame: before, 3, 6 and 24 hours after inhaled allergen challenge
Quantification of allergic inflammatory response induced by inhalation in non-invasive exhaled particles at multiple time-points by analyzing soluble mediators using MSD multiplex assays -> At least, but not limited to IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, INF-alpha, MMP-9, CXCL1, SP-D, albumin [pg/ml]
Exploratory (1. priority) Changes in non-invasive exhaled particles [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]after segmental allergen challenge
Time frame: before, 3, 6 and 24 hours after segmental allergen challenge
Quantification of allergic inflammatory response induced by segmental allergen challenge in non-invasive exhaled particles at multiple time-points by analyzing soluble mediators using MSD multiplex assays -> At least, but not limited to IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, INF-alpha, MMP-9, CXCL1, SP-D, albumin [pg/ml]
Exploratory (1. priority) Changes in cell analyzation in BAL [i.e.total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells] after segmental allergen challenge
Time frame: 24 hours after segemental allergen challenge
Quantification of allergic inflammatory response induced by segmental allergen challenge in BAL by analyzing cellularity and functionality using microscopy, flow cytometry and chipcytometry ->At least, but not limited to total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells [×10^6 cells/ml]
Exploratory (1. priority) Changes in cell analyzation in Sputum [i.e.total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells] after inhalative allergen challenge
Time frame: before, 6 and 24 hours after inhaled allergen challenge
Quantification of allergic inflammatory response induced by inhalation in sputum by analyzing cellularity and functionality using microscopy, flow cytometry and chipcytometry -> At least, but not limited to total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells [×10^6 cells/ml]
4 secondary outcomes
Exploratory (2. priority) Detection of Ribonucleic acid (RNA) in exhaled particles
Time frame: before, 3, 6, and 24 hours after allergen challenge
Exploratory (2. priority) Changes in Fractional exhaled nitric oxide (FeNO) after inhalative allergen challenge
Time frame: before, 3, 6, and 24 hours after inhaled allergen challenge
Exploratory (2. priority) Changes in FeNO after segmental allergen challenge
Time frame: before, 3, 6 and 24 hours after segmental allergen challenge
Exploratory (2. priority) Quantification of regional ventilation, perfusion, and diffusion by magnetic resonance imaging (MRI)
Time frame: before and 6 hours after inhaled allergen challenge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing allergen challenge in people with Mild Allergic Asthma, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Hohlfeld, Prof. Dr. (+49 511 5350-8101, jens.hohlfeld@item.fraunhofer.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 24 hours after segmental allergen challenge). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.