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

Allergic Rhinitis Due to Grass Pollen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06104293
• Other study ID #: ALY-005
• Status: Completed
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: April 6, 2023

Study information

• Verified date: November 2023
• Source: Alyatec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 6, 2023
• Est. primary completion date: February 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Allergic Rhinitis Due to Grass Pollen
• Rhinitis
• Rhinitis, Allergic

Intervention

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.

Locations

Country	Name	City	State
France	ALYATEC	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Alyatec

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   ALYATEC website