Allergic ConjunctivitisNCT04641130
Clinical Validation Study in Allergic Conjunctivitis to Birch Pollen During Allergen Challenge in ALYATEC EEC
A study testing Exposure to birch pollen in EEC in people with Allergic Conjunctivitis, run by Alyatec at 1 site in France.
Trial summary
This is a single center open study designed to determine the concentration of airborne birch pollen inducing an allergic conjunctivitis response in individuals allergic to birch pollen, during allergen 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 Conjunctivitis
- What is being tested?
- Exposure to birch pollen in EEC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2017to 11 Sep 2017
- 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
- Subjects having signed the informed consent
- Subjects affiliated to a social security scheme
- Subjects with birch pollen rhinitis and conjunctivitis with:
- A history of rhinoconjunctivitis for at least the last 2 consecutive pollen seasons.
- A positive skin prick-test to birch (wheal diameter >6 mm compared to the negative control),
- Specific immunoglobulin E (IgE) for birch> 0.1 kIU/l
- Women of childbearing potential must have a negative pregnancy test during the entire study period with an effective means of contraception: oral contraceptives, intrauterine device, condom with spermicide for at least one month before inclusion in the study and for the duration of the study. At each study visit and each exposure on D1, a urine pregnancy test will be performed.
- A positive conjunctival provocation test to birch during the screening visit at a dilution of 100IR/ml maximum
Who cannot join
- Known asthmatic subjects allergic to birch pollen
- Use of oral corticosteroids in the 4 weeks preceding inclusion in the study
- Use of biotherapy in the 4 months preceding inclusion in the study
- Desensitization to birch pollen in the last 5 years
- Uncontrolled chronic pathologies (hypertension, cardiac, respiratory, renal pathology).
- Active autoimmune disease
Show all 10Show fewer
- Uncontrolled systemic hypertension
- Subjects who participated in another clinical study in the three months prior to inclusion
- Pregnancy and breast feeding
- Inability to understand and act upon the information provided
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation and Reproducibility Study of the ALYATEC Allergen Exposure Chamber by Determining the Concentration of Birch Pollen Allergen Inducing Conjunctivitis in Subjects Allergic to Birch Pollen.
This is a single center open study designed to determine the concentration of airborne birch pollen inducing an allergic conjunctivitis response in individuals allergic to birch pollen, during allergen exposures in the Alyatec environmental exposure chamber (EEC).
- Conditions
- Allergic Conjunctivitis
- Being tested
- Exposure to birch pollen in EEC
- Keywords
- Allergy, Conjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic, Hypersensitivity, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to birch pollen in EECOther
Patients are exposed to airborne birch pollen allergen. The duration of each exposure is 4h maximum.
| Study group | Role | What they receive |
|---|---|---|
| Exposure to birch pollen | Experimental | Step 1: dose validation 16 subjects are exposed for 2 consecutive days (D1 + D2), to the same aerial concentration of Bet v1.
The main objective is achieved if the Abelson score is ≥ 5 on J1 or J2. If the main objective is achieved for the 60 ng/m3 concentration, 8 responder subjects will directly perform step 2.
If the main objective is not achieved for the 60 ng/m3 concentration, the subjects will be exposed between 7 to 10 days after exposure 1, to an allergen concentration of 120 ng/m3 (Exposure 2: D1 + D2).
Step 2: reproducibility Once the allergen concentration has been determined (step 1), 8 of the responder subjects from step 1 are exposed again to this same concentration, during 2 additional exposures (Exposure 3: D1 + D2 and Exposure 4: D1 + D2), at least 7 days apart.
A wash-out period of at least 7 days is observed between step 1 and 2. The duration of allergen exposure will be a maximum of 4 hours for all exposures. Receives: Other: Exposure to birch pollen in EEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the concentration of birch pollen allergen (in ng/m3 of Bet v1) necessary to induce a conjunctival response in at least 50% of subjects allergic to birch.
A positive conjunctival response is defined by an Abelson score ≥ 5.
Measured: 4 hours exposure in EEC
Secondary outcomes (7)
Evaluate the reproducibility of allergen exposure in the ALYATEC EEC
The reproducibility of the exposure will be assessed by measuring the quantity of birch pollen allergen (ng Bet v1) inducing a conjunctival response during step 2.
Measured: 4 hours exposure in EEC
Study the effect of EEC birch pollen exposure on symptoms of rhino-conjunctivitis.
The effect of the exposure on the rhinoconjunctival response will be assessed by Rhinoconjunctivitis Total Symptom Score (RTSS).
The RTSS is the sum of 6 rhinoconjunctivitis symptom scores: sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes.
Each symptom is graded in a 4-point scale as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. It ranges from 0 to 18. The lower the score, the better the outcome.
Measured: 4 hours exposure in EEC
Study the effect of EEC birch pollen exposure on symptoms of rhinitis
The effect of the exposure on the rhinitis response will be assessed by rhinitis Visual Analogue Scale (VAS).
The rhinitis VAS is a measurement of patient's subjective evaluation of symptoms severity. Patients will score the severity of their nasal symptoms on a scale, with 0 meaning no symptoms and 10 meaning the worst symptoms.
Measured: 4 hours exposure in EEC
Study the effect of EEC birch pollen exposure on symptoms of conjunctivitis.
The effect of the exposure on the conjunctival response will be assessed by Conjunctivitis Visual Analogue Scale (VAS).
The conjunctivitis VAS is a measurement of patient's subjective evaluation of symptoms severity. Patients will score the severity of their ocular symptoms on a scale, with 0 meaning no symptoms and 10 meaning the worst symptoms.
Measured: 4 hours exposure in EEC
Measure the amount of particles carrying the allergens.
The amount of particles carrying the allergen will be measured with counters located in the exposure chamber.
Measured: 4 hours exposure in EEC
Measure the aerodynamic diameter of the particles carrying the allergens.
The aerodynamic diameter of the particles carrying the allergen will be measured with counters located in the exposure chamber.
Measured: 4 hours exposure in EEC
Evaluate changes in mitochondrial respiration
The changes in mitochondrial respiration will be done by evaluating the modifications of the I to IV complex of the mitochondrial respiratory chain, before and after allergen exposure
Measured: 4 hours exposure in EEC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start13 Jul 2017
- Primary completion30 Aug 2017
- Study completion11 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT04641130
- Sponsor's protocol ID
- ALY-002B
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 16 Dec 2020
- Results posted
- 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 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Reproducibility Study of the ALYATEC Allergen Exposure Chamber by Determining the Concentration of Birch Pollen Allergen Inducing Conjunctivitis in Subjects Allergic to Birch Pollen.
- ClinicalTrials.gov ID
- NCT04641130
- Acronym / sponsor ID
- ALY-002B
- Conditions
- Allergic Conjunctivitis
- Keywords
- Allergy, Conjunctivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AlyatecIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 11 Sep 2017 (actual)
- First posted
- 23 Nov 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.
This is a single center open study designed to determine the concentration of airborne birch pollen inducing an allergic conjunctivitis response in individuals allergic to birch pollen, during allergen exposures in the Alyatec environmental exposure chamber (EEC).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposure to birch pollen | Experimental | Other: Exposure to birch pollen in EECStep 1: dose validation 16 subjects are exposed for 2 consecutive days (D1 + D2), to the same aerial concentration of Bet v1. The main objective is achieved if the Abelson score is ≥ 5 on J1 or J2. If the main objective is achieved for the 60 ng/m3 concentration, 8 responder subjects will directly perform step 2. If the main objective is not achieved for the 60 ng/m3 concentration, the subjects will be exposed between 7 to 10 days after exposure 1, to an allergen concentration of 120 ng/m3 (Exposure 2: D1 + D2). Step 2: reproducibility Once the allergen concentration has been determined (step 1), 8 of the responder subjects from step 1 are exposed again to this same concentration, during 2 additional exposures (Exposure 3: D1 + D2 and Exposure 4: D1 + D2), at least 7 days apart. A wash-out period of at least 7 days is observed between step 1 and 2. The duration of allergen exposure will be a maximum of 4 hours for all 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)
- Subjects having signed the informed consent
- Subjects affiliated to a social security scheme
- Subjects with birch pollen rhinitis and conjunctivitis with:
- A history of rhinoconjunctivitis for at least the last 2 consecutive pollen seasons.
- A positive skin prick-test to birch (wheal diameter >6 mm compared to the negative control),
Key exclusion criteria (10 listed)
- Known asthmatic subjects allergic to birch pollen
- Use of oral corticosteroids in the 4 weeks preceding inclusion in the study
- Use of biotherapy in the 4 months preceding inclusion in the study
- Desensitization to birch pollen in the last 5 years
- Uncontrolled chronic pathologies (hypertension, cardiac, respiratory, renal pathology).
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 birch pollen in EECPatients are exposed to airborne birch pollen allergen. The duration of each exposure is 4h maximum. | Other | Exposure to birch pollen |
Primary outcome
Determine the concentration of birch pollen allergen (in ng/m3 of Bet v1) necessary to induce a conjunctival response in at least 50% of subjects allergic to birch.
Time frame: 4 hours exposure in EEC
A positive conjunctival response is defined by an Abelson score ≥ 5.
7 secondary outcomes
Evaluate the reproducibility of allergen exposure in the ALYATEC EEC
Time frame: 4 hours exposure in EEC
Study the effect of EEC birch pollen exposure on symptoms of rhino-conjunctivitis.
Time frame: 4 hours exposure in EEC
Study the effect of EEC birch pollen exposure on symptoms of rhinitis
Time frame: 4 hours exposure in EEC
Study the effect of EEC birch pollen exposure on symptoms of conjunctivitis.
Time frame: 4 hours exposure in EEC
Measure the amount of particles carrying the allergens.
Time frame: 4 hours exposure in EEC
Measure the aerodynamic diameter of the particles carrying the allergens.
Time frame: 4 hours exposure in EEC
Evaluate changes in mitochondrial respiration
Time frame: 4 hours exposure in EEC
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 16 Dec 2020.
- 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 birch pollen in EEC in people with Allergic Conjunctivitis, 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 10 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 16 Dec 2020. 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. 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?
Determine the concentration of birch pollen allergen (in ng/m3 of Bet v1) necessary to induce a conjunctival response in at least 50% of subjects allergic to birch. (time frame: 4 hours exposure in EEC). 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 16 Dec 2020.