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

NCT ID: NCT06104293

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-16

Study Completion Date

2023-04-06

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Rhinitis Due to Grass Pollen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single-center, randomized, crossover, double-blind, controlled study.
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The grass pollen allergen (Phl p 5) concentrations corresponding to concentrations A, B, C and D are assigned randomly by the technician and the pharmacist of the exposure chamber so that neither the investigator, the participants nor the clinical and medical staff are aware of the exposure doses.

Study Groups

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Group 1

Concentration A - Concentration B - Concentration C - Concentration D

Group Type OTHER

Grass Pollen Allergen Exposure

Intervention Type OTHER

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.

Group 2

Concentration B - Concentration C - Concentration D - Concentration A

Group Type OTHER

Grass Pollen Allergen Exposure

Intervention Type OTHER

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.

Group 3

Concentration C - Concentration D - Concentration A - Concentration B

Group Type OTHER

Grass Pollen Allergen Exposure

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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;

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alyatec

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ALYATEC

Strasbourg, , France

Site Status

Countries

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France

Related Links

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https://www.alyatec.com/

ALYATEC website

Other Identifiers

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ALY-005

Identifier Type: -

Identifier Source: org_study_id