Status:
COMPLETED
Determination of Grass Pollen Allergen Concentration Inducing Rhinoconjunctivitis Symptoms in Subjects Allergic to Grass Pollen in ALYATEC Allergen Exposure Chamber
Lead Sponsor:
Alyatec
Conditions:
Allergic Rhinitis Due to Grass Pollen
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Main
- 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
- 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;
Key Trial Info
Start Date :
November 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06104293
Start Date
November 16 2022
End Date
April 6 2023
Last Update
November 27 2023
Active Locations (1)
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1
ALYATEC
Strasbourg, France