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Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure Chamber

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ClinicalTrials.gov Identifier: NCT04583202
Recruitment Status : Active, not recruiting
First Posted : October 12, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Alyatec

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)

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Allergy to Pollen Rhinoconjunctivitis Other: Exposure to placebo Other: Exposure to allergen Not Applicable

Detailed Description:

This is a single-center, single-blind, placebo-controlled study. The first part of the study consists of 6 exposure sessions in Alyatec EEC, including placebo and birch pollen allergen exposures.

The second part of the study involves in-field evaluations of rhinitis and conjunctivitis symptoms during birch pollen season.

Alyatec environmental exposure chamber, also called allergen challenge chamber, allows to evaluate allergic symptoms in standardized and reproducible conditions. All the metrological parameters (temperature, air flow, hygrometry ...) are controlled as well as the allergen concentration diffused in the room.

This enables to induce and observe rhinitis, conjunctivitis and asthma symptoms for up to 20 patients at the same time, in a reproducible way and without the potential perturbations or contaminations of the natural environment.

The current study aims to get specific information about allergic symptoms induced in the Alyatec EEC chamber in patients sensitized to birch pollen allergen.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure Chamber
Actual Study Start Date : February 24, 2020
Actual Primary Completion Date : October 19, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen

Arm Intervention/treatment
Placebo Comparator: Placebo exposure
All patients undergo 2 placebo exposures
Other: Exposure to placebo
Patients are exposed to a placebo for 4h in the Alyatec EEC

Experimental: Birch Pollen Exposure
All patients undergo 4 allergen exposures
Other: Exposure to allergen
Patients are exposed to birch pollen allergens for 4h in the Alyatec EEC




Primary Outcome Measures :
  1. Total Nasal Symptom Score [ Time Frame: 4 hours exposure ]
    To assess the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.


Secondary Outcome Measures :
  1. Visual Analogue Scale for rhinitis [ Time Frame: 4 hours exposure ]
    To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

  2. Total Nasal Symptom Score [ Time Frame: 4 hours exposure ]
    To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

  3. Visual Analogue Scale for conjunctivitis [ Time Frame: 4 hours exposure ]
    To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

  4. Total Ocular Symptom Score [ Time Frame: 4 hours exposure ]
    To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

  5. Peak Nasal Inspiratory Flow [ Time Frame: 4 hours exposure ]
    To evaluate the nasal obstruction during exposure to birch allergens compared to placebo in the ALYATEC EEC.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583202


Locations
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France
Alyatec
Strasbourg, Grand Est, France, 67000
Sponsors and Collaborators
Alyatec
Investigators
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Principal Investigator: Frédéric de Blay, Pr. Alyatec
Additional Information:
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Responsible Party: Alyatec
ClinicalTrials.gov Identifier: NCT04583202    
Other Study ID Numbers: ALY-004
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alyatec:
Environmental Exposure Chamber
Allergen Exposure Chamber
Allergen provocation test
Birch pollen
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases