Clinical trial NCT06104293: Determination of Grass Pollen Allergen Concentration Inducing Rhinoconjunctivitis Symptoms in Subjects Allergic to Grass Pollen in ALYATEC Allergen Exposure Chamber
Official title: Determination of Grass Pollen Allergen Concentration Inducing Rhinoconjunctivitis Symptoms in Subjects Allergic to Grass Pollen in ALYATEC Allergen Exposure Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis Due to Grass Pollen
Keywords: Allergy
Rhinitis
Pollen
Lead sponsor: Alyatec
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-center, randomized, crossover, double-blind, controlled study.
Primary purpose: OTHER

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.


Eligibility 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;

Primary outcomes:
measure: 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)
timeFrame: 0 to 3 hours
Secondary outcomes:
measure: Time to obtain a rhino-conjunctivitis response during the 3 hours of exposure to grass pollen allergens in the ALYATEC EEC
timeFrame: 0 to 3 hours
measure: 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)
timeFrame: 0 to 3 hours
measure: Frequency of bronchial response during 3 hours of exposure in the ALYATEC EEC
timeFrame: 0 to 3 hours
measure: Use of concomitant medications during and after exposures in the EEC ALYATEC
timeFrame: 0 to 24 hours
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: ALYATEC
Study officials:
References: