- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04663880
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Mite Allergic Subjects With Asthma
Validation Study of the ALYATEC Allergen Exposure Chamber by Determining the Concentration of House Dust Mite Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Mite
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne house dust mite allergen inducing bronchial response in asthmatic subjects allergic to mite, during allergen exposures in the Alyatec environmental exposure chamber (EEC).
The study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne house dust mite allergen in Alyatec EEC.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Grand Est
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Strasbourg, Grand Est, France, 67000
- ALYATEC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects having signed the informed consent
- Subjects affiliated to a social security scheme
- Positive metacholine test
- FEV1 value > 70% of theoretical FEV1 value
- Asthma Control Test (ACT) ≥ 20/25 in 4 weeks prior to EEC exposure
Group A:
- Mild allergic asthma to HDM (GINA 1 or 2) with associated rhinitis and/or conjunctivitis.
- Positive skin prick-test to Dpt and Df (wheal diameter >5 mm compared to the negative control)
- Specific immunoglobulin E (IgE) for Dpt and Df > 0.7 kU/L
Group B:
- Mild allergic asthma (GINA 1 or 2) not sensitized to HDM with associated rhinitis and/or conjunctivitis.
- Negative skin prick-test and specific IgE for Dpt and Df.
- Positive skin prick-test and specific IgE for another allergen.
Exclusion Criteria:
- Uncontrolled asthma
- Asthma Control Test (ACT) < 20/25 in 4 weeks prior to EEC exposure
- Use of oral corticosteroids in the 4 weeks preceding inclusion in the study
- Use of biotherapy in the 4 months preceding inclusion in the study
- Existence of a severe obstructive syndrome with FEV1 <70% of the theoretical value
- Obstruction triggered by spirometric evaluations
- Hospitalization for asthma or exacerbation in the last 4 weeks
- History of Acute Severe Asthma requiring hospitalization in intensive care or intubation
- Desensitization to dust mite allergens in the last 5 years
- Sensitization to allergens in the indoor environment (cat allergens or molds) with obvious exposure to these allergens
- Active tobacco: plus 10 cigarettes / day and tobacco history of +10 PA
- Uncontrolled systemic arterial hypertension
- Recent myocardial infarction (<3 months)
- Recent stroke (<3 months)
- Known arterial aneurysm
- Epilepsy under treatment
- Progressive tumor pathology
- Chronic renal pathology
- Hypersensitivity to one of the excipients used
- Subjects who participated in another clinical study in the three months prior to inclusion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Asthmatic subjects allergic to house dust mite
24 subjects were randomized in a doubleblinded manner into six subgroups.
All were exposed first to placebo then in cross over to three different Der p1 concentrations, respectively 15, 25, and 46 ng/m3.
|
Patients are exposed to placebo (saline solution) in the EEC for 4h maximum
Patients are exposed to different concentrations of airborne HDM allergen (Der p1) in the EEC for 4h maximum
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ACTIVE_COMPARATOR: Asthmatic subjects not allergic to house dust mite
13 subjects were exposed first to placebo then to Der p1 concentration of 25 ng/m3.
|
Patients are exposed to placebo (saline solution) in the EEC for 4h maximum
Patients are exposed to a single concentration of airborne HDM allergen (Der p1) in the EEC for 4h maximum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the concentration of HDM allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to HDM
Time Frame: 10 hours: 4 hours of exposure in the EEC then 6 hours post-exposure.
|
The bronchial response is evaluated by measuring FEV1 value during EEC exposure. Early asthmatic response (EAR) occurs when a 20% drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1. Late bronchial response (LAR) occurs when a 15% drop in FEV1 or 20% drop in peak flow is detected 1 to 6h after the EAR. |
10 hours: 4 hours of exposure in the EEC then 6 hours post-exposure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the effect of the exposure on rhinitis symptoms
Time Frame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
|
The effect of the exposure on the rhinitis response is assessed with Total Nasal Symptom Score (TNSS). The TNSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity). |
28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
|
Evaluate the effect of the exposure on conjunctivitis symptoms
Time Frame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
|
The effect of the exposure on the conjunctivitis response is assessed with Total Ocular Symptom Score (TOSS). The TOSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity). |
28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
|
Evaluate the safety of allergenic exposure in EEC
Time Frame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
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Safety is assessed with clinical evaluations performed during the 4h of exposure in the EEC
|
28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
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Evaluate the metrology of the EEC
Time Frame: 4 hours of exposure in EEC
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The metrology is assessed with the measure of allergen concentration and particules diameter thanks to sensors in the chamber.
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4 hours of exposure in EEC
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Evaluate the specificity of the bronchial response
Time Frame: 4 hours of exposure in EEC
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The specificity of the bronchial response is assessed with the HDM exposure in the EEC of asthmatic subjects non allergic to HDM.
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4 hours of exposure in EEC
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALY-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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