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

NCT04663880 | Completed

• 1 other identifier: ALY-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Asthma; Allergy to House Dust; Allergy

Keywords

Allergy; Asthma; House dust mite

Outcome Measures

Primary Outcomes (1)

• 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.

  10 hours: 4 hours of exposure in the EEC then 6 hours post-exposure.

Secondary Outcomes (5)

• Evaluate the safety of allergenic exposure in EEC

  28 hours: 4 hours of exposure in EEC then 24 hours post-exposure

• Evaluate the metrology of the EEC

  4 hours of exposure in EEC

• Evaluate the specificity of the bronchial response

  4 hours of exposure in EEC

• Evaluate the effect of the exposure on rhinitis symptoms

  28 hours: 4 hours of exposure in EEC then 24 hours post-exposure

• Evaluate the effect of the exposure on conjunctivitis symptoms

  28 hours: 4 hours of exposure in EEC then 24 hours post-exposure

Study Arms (2)

Asthmatic subjects allergic to house dust mite

EXPERIMENTAL

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.

Other: Exposure to placebo in EEC; Other: Exposure to three concentrations of HDM allergen in EEC

Asthmatic subjects not allergic to house dust mite

ACTIVE COMPARATOR

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

Other: Exposure to placebo in EEC; Other: Exposure to a single concentration of HDM allergen in EEC

Interventions

Exposure to placebo in EEC OTHER

Patients are exposed to placebo (saline solution) in the EEC for 4h maximum

Asthmatic subjects allergic to house dust mite; Asthmatic subjects not allergic to house dust mite

Exposure to three concentrations of HDM allergen in EEC OTHER

Patients are exposed to different concentrations of airborne HDM allergen (Der p1) in the EEC for 4h maximum

Asthmatic subjects allergic to house dust mite

Exposure to a single concentration of HDM allergen in EEC OTHER

Patients are exposed to a single concentration of airborne HDM allergen (Der p1) in the EEC for 4h maximum

Asthmatic subjects not allergic to house dust mite

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Uncontrolled asthma
• Asthma Control Test (ACT) \< 20/25 in 4 weeks prior to EEC exposure
• 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

Sponsors & Collaborators

• Alyatec: lead

Study Sites (1)

Alyatec

Strasbourg, Grand Est, 67000, France

Location

Related Publications (1)

• 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.

  PMID: 30919704 RESULT

Related Links

• Alyatec website

MeSH Terms

Conditions

Hypersensitivity; Asthma

Condition Hierarchy (Ancestors)

Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate

Study Officials

• Frédéric de Blay, Pr.

  Alyatec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, cross-over study including two study groups

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 11, 2020
• Study Start: August 30, 2016
• Primary Completion: January 23, 2017
• Study Completion: February 15, 2017
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)