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

NCT04678063 | Completed

• 1 other identifier: ALY-003
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Asthma; Allergy; Allergy to Cats

Keywords

Cat allergy; Allergic rhinitis; Allergy

Outcome Measures

Primary Outcomes (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.

  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.

  10 hours: 4 hours of exposure in 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 allergen concentration in the EEC

  4 hours exposure in EEC

• Evaluate the specificity of the bronchial response

  4 hours 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 cat

EXPERIMENTAL

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; Other: Exposure to dose A and dose B of cat allergen

Asthmatic allergic subjects not sensitized to cat

ACTIVE COMPARATOR

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; Other: Exposure to a single dose of cat allergen

Interventions

Exposure to Placebo OTHER

Patients are exposed to placebo in the EEC

Asthmatic allergic subjects not sensitized to cat; Asthmatic subjects allergic to cat

Exposure to dose A and dose B of cat allergen OTHER

Patients are exposed to dose A and B for successive exposures in the EEC

Asthmatic subjects allergic to cat

Exposure to a single dose of cat allergen OTHER

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)

Asthmatic allergic subjects not sensitized to cat

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Uncontrolled asthma, ACT asthma control questionnaire less than 20, in the last 4 weeks
• Uncontrolled asthma 2 weeks after interruption of LABA
• 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 severe acute asthma requiring hospitalization in intensive care or intubation
• 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

Sponsors & Collaborators

• Alyatec: lead

Study Sites (1)

Alyatec

Strasbourg, Grand Est, 67000, France

Location

Related Links

• Alyatec website

MeSH Terms

Conditions

Hypersensitivity; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Immune System Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate

Study Officials

• Frédéric de Blay, Pr.

  Alyatec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• 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 21, 2020
• Study Start: April 10, 2017
• Primary Completion: June 15, 2017
• Study Completion: July 11, 2017
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)