NCT04583202

Brief Summary

The aim of this study is to assess the nasal and conjunctival response in subjects allergic to birch pollen during controlled exposures in the ALYATEC environmental exposure chamber (EEC)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

June 9, 2021

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

September 30, 2020

Last Update Submit

June 8, 2021

Conditions

Allergic RhinitisAllergy to PollenRhinoconjunctivitis

Keywords

Environmental Exposure ChamberAllergen Exposure ChamberAllergen provocation testBirch pollen

Outcome Measures

Primary Outcomes (1)

  • Total Nasal Symptom Score

    To assess the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

    4 hours exposure

Secondary Outcomes (5)

  • Visual Analogue Scale for rhinitis

    4 hours exposure

  • Total Nasal Symptom Score

    4 hours exposure

  • Visual Analogue Scale for conjunctivitis

    4 hours exposure

  • Total Ocular Symptom Score

    4 hours exposure

  • Peak Nasal Inspiratory Flow

    4 hours exposure

Study Arms (2)

Placebo exposure

PLACEBO COMPARATOR

All patients undergo 2 placebo exposures

Other: Exposure to placebo

Birch Pollen Exposure

EXPERIMENTAL

All patients undergo 4 allergen exposures

Other: Exposure to allergen

Interventions

Exposure to placeboOTHER

Patients are exposed to a placebo for 4h in the Alyatec EEC

Placebo exposure
Exposure to allergenOTHER

Patients are exposed to birch pollen allergens for 4h in the Alyatec EEC

Birch Pollen Exposure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A clinical history of allergic rhinitis to birch pollen for at least 2 consecutive pollen seasons requiring the taking of a symptomatic drug with or without associated asthma
  • Positive skin prick tests for birch pollen (\> 3 mm)
  • IgE specific to birch \> 0.75 kUI / L.
  • Positive unit rapid nasal provocation test for birch pollen
  • Subjects having signed informed consent
  • Subjects affiliated to a social security scheme
  • Subjects able to understand and complete the procedures related to the study
  • Women of childbearing potential should have a negative pregnancy test throughout the study period with effective contraception

You may not qualify if:

  • Specific immunotherapy (SIT) for birch allergens for more than a month in the 3 years preceding the screening
  • Current use of Specific immunotherapy for another allergen
  • Medical history of anaphylaxis following exposure to birch pollen
  • Medical history of anaphylaxis linked to another allergen in the last 6 weeks
  • Nasal polyps, nasal septum deviation or diagnosis of non-allergic rhinitis
  • Subjects allergic to indoor environmental allergens (cat allergens, mold, dust mites) with - Obvious exposure to these allergens.
  • Uncontrolled allergic pathology (rhinitis, conjunctivitis)
  • Forced expiratory volume in 1 second (FEV1) \<70% of predicted normal values
  • Moderate to severe asthma (GINA 3 to 5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alyatec

Strasbourg, Grand Est, 67000, France

Location

Related Links

MeSH Terms

Conditions

Rhinitis, AllergicRhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Frédéric de Blay, Pr.

    Alyatec

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 12, 2020

Study Start

February 24, 2020

Primary Completion

October 19, 2020

Study Completion

May 31, 2021

Last Updated

June 9, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)