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Outcome Measures

Primary Outcomes (1)

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 Outcomes (4)

Time to obtain a rhino-conjunctivitis response during the 3 hours of exposure to grass pollen allergens in the ALYATEC EEC
0 to 3 hours
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)
0 to 3 hours
Frequency of bronchial response during 3 hours of exposure in the ALYATEC EEC
0 to 3 hours
Use of concomitant medications during and after exposures in the EEC ALYATEC
0 to 24 hours

Study Arms (3)

Group 1

OTHER

Concentration A - Concentration B - Concentration C - Concentration D

Other: Grass Pollen Allergen Exposure

Group 2

OTHER

Concentration B - Concentration C - Concentration D - Concentration A

Other: Grass Pollen Allergen Exposure

Group 3

OTHER

Concentration C - Concentration D - Concentration A - Concentration B

Other: Grass Pollen Allergen Exposure

Interventions

Grass Pollen Allergen ExposureOther

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 1Group 2Group 3

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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));

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

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.

Purpose

OTHER

Intervention Model

CROSSOVER

Model Details: Single-center, randomized, crossover, double-blind, controlled study.

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

Group 1

Group 2

Group 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

Group 1

Group 2

Group 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations