Determination of Grass Pollen Allergen Concentration Inducing Rhinoconjunctivitis Symptoms in Subjects Allergic to Grass Pollen in ALYATEC Allergen Exposure Chamber

Not Applicable

Completed

• Conditions: Allergic Rhinitis Due to Grass Pollen
• Interventions: Other: Grass Pollen Allergen Exposure

• Registration Number: NCT06104293
• Lead Sponsor: Alyatec

Brief Summary

The aim of this study is to determine the optimal concentration of grass pollen allergens inducing rhinoconjunctivitis in subjects allergic to grass pollen in ALYATEC allergen exposure chamber.

Four concentrations of grass pollen allergen (Phl p 5) are tested during 3-hour exposures: 0, 30, 60 and 90 ng/m3.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-16
• Primary Completion: 2023-02-07
• Study Completion: 2023-04-06
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Subjects with symptoms of allergic rhinoconjunctivitis to grass pollen without associated asthma, requiring anti-allergic treatment for at least 2 consecutive pollen seasons;
• Subjects with positive skin prick tests to grass pollen extracts (Phleum pratense): papule diameter ≥ 5 mm compared to the negative control (NaCl reaction < 2 mm));
• Subjects with Phl p 5 specific recombinant Immunoglobulin E ≥ 0.70 kIU/L;
• Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted value at screening and before allergenic exposures;
• Women of childbearing age must have a negative pregnancy test at screening and before exposure visits;

Main

Exclusion Criteria

• Specific immunotherapy (SIT) to grass pollen allergens for more than one month in the 3 years preceding the screening visit;
• Ongoing specific immunotherapy to another allergen
• History of anaphylaxis following exposure to grass pollen or grass SITs;
• Asthma
• Ear, Nose & Throat or ocular surgical intervention in the 6 months preceding inclusion;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Grass Pollen Allergen Exposure	Concentration A - Concentration B - Concentration C - Concentration D
Group 3	Grass Pollen Allergen Exposure	Concentration C - Concentration D - Concentration A - Concentration B
Group 2	Grass Pollen Allergen Exposure	Concentration B - Concentration C - Concentration D - Concentration A

Primary Outcome Measures

Name	Time	Method
Optimal concentration of grass allergens (Phl p 5 in ng/m3) to induce a positive rhino-conjunctivitis response in subjects allergic to grass pollen during 3 hours of exposure to grass pollen allergens in the ALYATEC Environmental Exposure Chamber (EEC)	0 to 3 hours	The optimal concentration of grass pollen allergens Phl p 5 in ng/m3 will be determined by evaluating the Area Under the Curve (AUC) of the rhino-conjunctivitis TSS (Total Symptoms Score).; The value of the TSS varies from 0 (no symptom) to 24 (highest symptoms)

Secondary Outcome Measures

Name	Time	Method
Time to obtain a rhino-conjunctivitis response during the 3 hours of exposure to grass pollen allergens in the ALYATEC EEC	0 to 3 hours	The exposure time will be determined by the time necessary to obtain the first uncorrected TSS (Total Symptoms Score) score ≥ 12 and corrected ≥ 10.; The value of the TSS varies from 0 (no symptom) to 24 (highest symptoms)
Frequency of bronchial response during 3 hours of exposure in the ALYATEC EEC	0 to 3 hours	The frequency of bronchial response will be assessed by determining the number of subjects presenting at least one drop of FEV1 ≥ 20% during the 3 hours of exposure in ALYATEC EEC.
Optimal concentration of grass allergens (Phl p 5 in ng/m3) to induce a positive rhinitis response in subjects allergic to grass pollen during 3 hours of exposure to grass allergens in the ALYATEC Environmental Exposure Chamber (EEC)	0 to 3 hours	The optimal concentration of grass pollen allergens Phl p 5 in ng/m3 will be determined by evaluating the Area Under the Curve (AUC) of the rhinitis-related questions of the TSS (nasal congestion, rhinorrhea, nasal itching, sneezing).; The value of the rhinitis-related questions of the TSS varies from 0 (no symptom) to 12 (highest symptoms)
Use of concomitant medications during and after exposures in the EEC ALYATEC	0 to 24 hours	The use of concomitant medications will be assessed by determining the number of subjects using at least one treatment during and up to 24 hours after the exposure.

Trial Locations

Locations (1)

ALYATEC; 🇫🇷 Strasbourg, France