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

NCT06104293 | Completed

• 1 other identifier: ALY-005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis Due to Grass Pollen

Keywords

Allergy; Rhinitis; Pollen

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 Exposure 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 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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));
• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Alyatec: lead

Study Sites (1)

ALYATEC

Strasbourg, France

Location

Related Links

• ALYATEC website

MeSH Terms

Conditions

Hypersensitivity; Rhinitis

Condition Hierarchy (Ancestors)

Immune System Diseases; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

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
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: November 16, 2022
• Primary Completion: February 7, 2023
• Study Completion: April 6, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)