Status:
COMPLETED
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Mite Allergic Subjects With Asthma
Lead Sponsor:
Alyatec
Conditions:
Allergic Asthma
Allergy to House Dust
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
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, du...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2017
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04663880
Start Date
August 30 2016
End Date
February 15 2017
Last Update
December 11 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Alyatec
Strasbourg, Grand Est, France, 67000