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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis Due to Grass Pollen
• Intervention / Treatment: Other: Grass Pollen Allergen Exposure

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France
    • Alyatec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Main 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; Concentration A - Concentration B - Concentration C - Concentration D	Other: Grass Pollen Allergen Exposure; After the screening visit, subjects are randomized into 3 groups presenting a sequence of allergen concentrations with randomly defined concentrations of Ph l p 5 (0, 30, 60 and 90 ng/m3). Each participant undergo four different 3-hour exposure sessions to grass pollen allergen corresponding to the four different allergen concentrations.
Other: Group 2; Concentration B - Concentration C - Concentration D - Concentration A	Other: Grass Pollen Allergen Exposure; After the screening visit, subjects are randomized into 3 groups presenting a sequence of allergen concentrations with randomly defined concentrations of Ph l p 5 (0, 30, 60 and 90 ng/m3). Each participant undergo four different 3-hour exposure sessions to grass pollen allergen corresponding to the four different allergen concentrations.
Other: Group 3; Concentration C - Concentration D - Concentration A - Concentration B	Other: Grass Pollen Allergen Exposure; After the screening visit, subjects are randomized into 3 groups presenting a sequence of allergen concentrations with randomly defined concentrations of Ph l p 5 (0, 30, 60 and 90 ng/m3). Each participant undergo four different 3-hour exposure sessions to grass pollen allergen corresponding to the four different allergen concentrations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	0 to 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of bronchial response during 3 hours of exposure in the ALYATEC EEC	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.	0 to 3 hours
Use of concomitant medications during and after exposures in the EEC ALYATEC	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.	0 to 24 hours
Time to obtain a rhino-conjunctivitis response during the 3 hours of exposure to grass pollen allergens in the ALYATEC EEC	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)	0 to 3 hours
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)	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)	0 to 3 hours

Collaborators and Investigators

• Sponsor: Alyatec

Publications and helpful links

Helpful Links

• ALYATEC website

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): February 7, 2023
• Study Completion (Actual): April 6, 2023

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Allergy; Rhinitis; Pollen
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: ALY-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No