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Completed

NCT Number: NCT04663880

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alyatec

Strasbourg, Grand Est, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposure to placebo in EEC

Other

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

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

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

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

    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.

Secondary outcomes

  1. Evaluate the safety of allergenic exposure in EEC

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

    Safety is assessed with clinical evaluations performed during the 4h of exposure in the EEC

  2. Evaluate the metrology of the EEC

    Time frame: 4 hours of exposure in EEC

    The metrology is assessed with the measure of allergen concentration and particules diameter thanks to sensors in the chamber.

  3. Evaluate the specificity of the bronchial response

    Time frame: 4 hours of exposure in EEC

    The specificity of the bronchial response is assessed with the HDM exposure in the EEC of asthmatic subjects non allergic to HDM.

  4. 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).

  5. 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).

Sponsors and collaborators

Lead sponsor

Alyatec

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2020
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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