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

Sponsor
Alyatec (Industry)
Overall Status
Completed
CT.gov ID
NCT04678063
Collaborator
(none)
31
1
2
3
10.3

Study Details

Study Description

Brief Summary

This is a randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, 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 cat allergen in Alyatec EEC.

Condition or Disease Intervention/Treatment Phase
  • Other: Exposure to Placebo
  • Other: Exposure to dose A and dose B of cat allergen
  • Other: Exposure to a single dose of cat allergen
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomized, double blind, cross-over study including two study groupsRandomized, double blind, cross-over study including two study groups
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
Validation Study of the ALYATEC Allergen Exposure Chamber (EEC) by Determining the Concentration of Cat Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Cat
Actual Study Start Date :
Apr 10, 2017
Actual Primary Completion Date :
Jun 15, 2017
Actual Study Completion Date :
Jul 11, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Asthmatic subjects allergic to cat

Group A will be randomized into 2 subgroups of 10 subjects: group A1 and A2. Both subgroupes will be exposed to placebo on exposure 1 then Subgroup A1 will be exposed to dose A on exposure 2 and dose B on exposure 3. Subgroup A2 will be exposed to dose B on exposure 2 and dose A on exposure 3. Dose A and B correspond to different Allergen concentration in the EEC.

Other: Exposure to Placebo
Patients are exposed to placebo in the EEC

Other: Exposure to dose A and dose B of cat allergen
Patients are exposed to dose A and B for successive exposures in the EEC

Active Comparator: Asthmatic allergic subjects not sensitized to cat

Group B will be exposed to placebo at exposure 1, and then at exposure 2, the concentration of cat allergens corresponding to the dose that achieved the main objective (Dose A or B).

Other: Exposure to Placebo
Patients are exposed to placebo in the EEC

Other: Exposure to a single dose of cat allergen
Patients are exposed to a single dose of cat allergen in the EEC according to the dose selected to achieve the main objective (dose A or B)

Outcome Measures

Primary Outcome Measures

  1. Determine the concentration of cat allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to cat. [10 hours: 4 hours of exposure in EEC then 6 hours post-exposure]

    The bronchial response is evaluated by measuring FEV1 value. Early asthmatic response (EAR) occurs when a 20 percent drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1. Late bronchial response (LAR) occurs when a 15 percent drop in FEV1 or 20 percent drop in peak flow is detected 1 to 6h after the EAR.

Secondary Outcome Measures

  1. Evaluate the safety of allergenic exposure in EEC [28 hours: 4 hours of exposure in EEC then 24 hours post-exposure]

    Safety is assessed with an asthma symptom self-report questionnaire performed during the 4h exposure and for 24h after the end of the exposure. The score was obtained from the sum of all four individual symptom scores (chest tightness, cough, wheezing and dyspnea) with a total possible score ranging from 0 (no symptoms) to 16 (maximum symptom intensity).

  2. Evaluate the allergen concentration in the EEC [4 hours exposure in EEC]

    The measurement of allergen concentration is performed with several sensors positioned in the chamber.

  3. Evaluate the specificity of the bronchial response [4 hours exposure in EEC]

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

  4. Evaluate the effect of the exposure on rhinitis symptoms [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Subjects having signed the informed consent

  • Subjects affiliated to a social security scheme

  • Non-specific bronchial hyperreactivity (HRBNS) assessed by a positive methacholine test

  • FEV1 value > 70% of theoretical FEV1 value

  • Asthma Control Test (ACT) ≥ 20/25 in 4 weeks prior to EEC exposure

  • Women of childbearing potential should have a negative pregnancy test throughout the study period with effective contraception.

Group A:
  • Cat allergic asthma (GINA 1, 2) associated with rhinitis and / or conjunctivitis symptoms triggered during an exposure to a cat.

  • Positive skin prick-test to cat allergen extract (wheal diameter >3 mm compared to the negative control) Specific immunoglobulin E (IgE) for cat allergen > 0.7 kU/L

Group B:
  • Mild allergic asthma (GINA 1 or 2) not sensitized to cat allergen with associated rhinitis and/or conjunctivitis.

  • Negative skin prick-test and specific IgE for cat allergen

  • Positive skin prick-test and specific IgE for another allergen.

Exclusion Criteria:
  • Uncontrolled asthma, ACT asthma control questionnaire less than 20, in the last 4 weeks

  • Uncontrolled asthma 2 weeks after interruption of LABA

  • Long-term treatment by LABA, within 2 weeks prior to inclusion

  • 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

  • Subjects treated with oral corticosteroids in the 4 weeks prior to inclusion in the study

  • History of severe acute asthma requiring hospitalization in intensive care or intubation

  • Subjects treated with biotherapy in the 4 months prior to inclusion in the study

  • Presence of a cat at home, or daily exposure to cat allergens

  • Desensitization to cat allergens in the last 6 months

  • Active tobacco: plus 10 cigarettes / day or tobacco history plus 10 PA

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alyatec Strasbourg Grand Est France 67000

Sponsors and Collaborators

  • Alyatec

Investigators

  • Principal Investigator: Frédéric de Blay, Pr., Alyatec

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Alyatec
ClinicalTrials.gov Identifier:
NCT04678063
Other Study ID Numbers:
  • ALY-003
First Posted:
Dec 21, 2020
Last Update Posted:
Dec 21, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alyatec
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2020