Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06104293
Other study ID # ALY-005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03290248 - Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis Phase 1/Phase 2
Completed NCT04878237 - Kinetics of Nasal Cytokine Responses to Mechanical Stimulation N/A
Completed NCT04802616 - The Influence of Nonspecific Immunostimulation on Changes in the Concentration of iNKT Cells Phase 3
Active, not recruiting NCT05297760 - Intralymphatic Immunotherapy With Polvac Grass & Rye Allergen Extract Phase 1/Phase 2
Recruiting NCT06061848 - Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT Phase 2/Phase 3
Not yet recruiting NCT04700852 - Efficacy of Puressentiel Protective Nasal Spray in Allergic Rhinitis N/A
Completed NCT05037955 - ILIT: Follow-up of Rhinitis Quality of Life
Active, not recruiting NCT05191186 - Documentation of Efficacy of Intralymphatic Allergen Immunotherapy Phase 3
Completed NCT04210193 - Is Intralymphatic Allergen Immunotherapy Effective and Safe? Phase 2/Phase 3
Completed NCT01953471 - Prospective Observational Study for Determination of Minimal Clinically Important Difference of Allergic Rhinitis Symptoms Due to Grass Pollen (Equinoxe 2) N/A

External Links