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

Alyatec

Status: Completed

Conditions: Allergic Rhinitis Due to Grass Pollen

Treatments: Other: Grass Pollen Allergen Exposure

Study type: Interventional

Funder types: Industry

Identifiers

NCT06104293

ALY-005

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups

Group 1

Other group

Description:

Concentration A - Concentration B - Concentration C - Concentration D

Treatment:

Other: Grass Pollen Allergen Exposure

Group 2

Other group

Description:

Concentration B - Concentration C - Concentration D - Concentration A

Treatment:

Other: Grass Pollen Allergen Exposure

Group 3

Other group

Description:

Concentration C - Concentration D - Concentration A - Concentration B

Treatment:

Other: Grass Pollen Allergen Exposure