Allergic RhinitisNCT04583202
Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure Chamber
A study testing Exposure to allergen in people with Allergic Rhinitis and Allergy to Pollen, run by Alyatec at 1 site in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis, Allergy to Pollen, Rhinoconjunctivitis
- What is being tested?
- Exposure to allergen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the 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.
- Conditions
- Allergic Rhinitis, Allergy to Pollen, Rhinoconjunctivitis
- Being tested
- Exposure to placebo, Exposure to allergen
- Keywords
- Environmental Exposure Chamber, Allergen Exposure Chamber, Allergen provocation test, Birch pollen
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to placeboOther
Patients are exposed to a placebo for 4h in the Alyatec EEC
Exposure to allergenOther
Patients are exposed to birch pollen allergens for 4h in the Alyatec EEC
| Study group | Role | What they receive |
|---|---|---|
| Placebo exposure | Placebo comparator | All patients undergo 2 placebo exposures Receives: Other: Exposure to placebo |
| Birch Pollen Exposure | Experimental | All patients undergo 4 allergen exposures Receives: Other: Exposure to allergen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score
To assess the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.
Measured: 4 hours exposure
Secondary outcomes (5)
Visual Analogue Scale for rhinitis
To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.
Measured: 4 hours exposure
Total Nasal Symptom Score
To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.
Measured: 4 hours exposure
Visual Analogue Scale for conjunctivitis
To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC.
Measured: 4 hours exposure
Total Ocular Symptom Score
To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC.
Measured: 4 hours exposure
Peak Nasal Inspiratory Flow
To evaluate the nasal obstruction during exposure to birch allergens compared to placebo in the ALYATEC EEC.
Measured: 4 hours exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start24 Feb 2020
- Primary completion19 Oct 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alyatec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric de Blay, Pr., Principal investigator, Alyatec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583202
- Sponsor's protocol ID
- ALY-004
- Status last verified
- Nov 2020
- First submitted
- 30 Sep 2020
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT04583202
- Acronym / sponsor ID
- ALY-004
- Conditions
- Allergic Rhinitis, Allergy to Pollen, Rhinoconjunctivitis
- Keywords
- Environmental Exposure Chamber, Allergen Exposure Chamber, Allergen provocation test, Birch pollen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AlyatecIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo exposure | Placebo comparator | Other: Exposure to placeboAll patients undergo 2 placebo exposures |
| Birch Pollen Exposure | Experimental | Other: Exposure to allergenAll patients undergo 4 allergen exposures |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to placeboPatients are exposed to a placebo for 4h in the Alyatec EEC | Other | Placebo exposure |
| Exposure to allergenPatients are exposed to birch pollen allergens for 4h in the Alyatec EEC | Other | Birch Pollen Exposure |
Primary outcome
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.
5 secondary outcomes
Visual Analogue Scale for rhinitis
Time frame: 4 hours exposure
Total Nasal Symptom Score
Time frame: 4 hours exposure
Visual Analogue Scale for conjunctivitis
Time frame: 4 hours exposure
Total Ocular Symptom Score
Time frame: 4 hours exposure
Peak Nasal Inspiratory Flow
Time frame: 4 hours exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Alyatec websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric de Blay, Pr. principal investigator
Alyatec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to allergen in people with Allergic Rhinitis and Allergy to Pollen, run by Alyatec at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Nasal Symptom Score (time frame: 4 hours exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.