search
Back to results

Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Mite Allergic Subjects With Asthma

Primary Purpose

Allergic Asthma, Allergy to House Dust, Allergy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exposure to placebo in EEC
Exposure to three concentrations of HDM allergen in EEC
Exposure to a single concentration of HDM allergen in EEC
Sponsored by
Alyatec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Allergic Asthma focused on measuring Allergy, Asthma, House dust mite

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alyatec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Asthmatic subjects allergic to house dust mite

Asthmatic subjects not allergic to house dust mite

Arm Description

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.

13 subjects were exposed first to placebo then to Der p1 concentration of 25 ng/m3.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Evaluate the safety of allergenic exposure in EEC
Safety is assessed with clinical evaluations performed during the 4h of exposure in the EEC
Evaluate the metrology of the EEC
The metrology is assessed with the measure of allergen concentration and particules diameter thanks to sensors in the chamber.
Evaluate the specificity of the bronchial response
The specificity of the bronchial response is assessed with the HDM exposure in the EEC of asthmatic subjects non allergic to HDM.
Evaluate the effect of the exposure on rhinitis symptoms
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).
Evaluate the effect of the exposure on conjunctivitis symptoms
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).

Full Information

First Posted
December 4, 2020
Last Updated
December 10, 2020
Sponsor
Alyatec
search

1. Study Identification

Unique Protocol Identification Number
NCT04663880
Brief Title
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Mite Allergic Subjects With Asthma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 30, 2016 (Actual)
Primary Completion Date
January 23, 2017 (Actual)
Study Completion Date
February 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alyatec

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma, Allergy to House Dust, Allergy
Keywords
Allergy, Asthma, House dust mite

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double blind, cross-over study including two study groups
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthmatic subjects allergic to house dust mite
Arm Type
Experimental
Arm Description
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.
Arm Title
Asthmatic subjects not allergic to house dust mite
Arm Type
Active Comparator
Arm Description
13 subjects were exposed first to placebo then to Der p1 concentration of 25 ng/m3.
Intervention Type
Other
Intervention Name(s)
Exposure to placebo in EEC
Intervention Description
Patients are exposed to placebo (saline solution) in the EEC for 4h maximum
Intervention Type
Other
Intervention Name(s)
Exposure to three concentrations of HDM allergen in EEC
Intervention Description
Patients are exposed to different concentrations of airborne HDM allergen (Der p1) in the EEC for 4h maximum
Intervention Type
Other
Intervention Name(s)
Exposure to a single concentration of HDM allergen in EEC
Intervention Description
Patients are exposed to a single concentration of airborne HDM allergen (Der p1) in the EEC for 4h maximum
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
10 hours: 4 hours of exposure in the EEC then 6 hours post-exposure.
Secondary Outcome Measure Information:
Title
Evaluate the safety of allergenic exposure in EEC
Description
Safety is assessed with clinical evaluations performed during the 4h of exposure in the EEC
Time Frame
28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Title
Evaluate the metrology of the EEC
Description
The metrology is assessed with the measure of allergen concentration and particules diameter thanks to sensors in the chamber.
Time Frame
4 hours of exposure in EEC
Title
Evaluate the specificity of the bronchial response
Description
The specificity of the bronchial response is assessed with the HDM exposure in the EEC of asthmatic subjects non allergic to HDM.
Time Frame
4 hours of exposure in EEC
Title
Evaluate the effect of the exposure on rhinitis symptoms
Description
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).
Time Frame
28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Title
Evaluate the effect of the exposure on conjunctivitis symptoms
Description
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).
Time Frame
28 hours: 4 hours of exposure in EEC then 24 hours post-exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric de Blay, Pr.
Organizational Affiliation
Alyatec
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alyatec
City
Strasbourg
State/Province
Grand Est
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30919704
Citation
Khayath N, Doyen V, Gherasim A, Radu C, Choual I, Beck N, Jacob A, Schoettel F, Vecellio L, Domis N, de Blay F. Validation of Strasbourg environmental exposure chamber (EEC) ALYATEC(R) in mite allergic subjects with asthma. J Asthma. 2020 Feb;57(2):140-148. doi: 10.1080/02770903.2018.1563902. Epub 2019 Mar 28.
Results Reference
result
Links:
URL
https://www.alyatec.com/en/
Description
Alyatec website

Learn more about this trial

Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Mite Allergic Subjects With Asthma

We'll reach out to this number within 24 hrs