Allergic AsthmaNCT04678063
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Cat Allergic Subjects With Asthma
A study testing Exposure to dose A and dose B of cat allergen and Exposure to a single dose of cat allergen in people with Allergic Asthma and Allergy, run by Alyatec at 1 site in France.
Trial summary
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, 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 Asthma, Allergy, Allergy to Cats
- What is being tested?
- Exposure to dose A and dose B of cat allergen and Exposure to a single dose of cat allergen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2017to 11 Jul 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
- Non-specific bronchial hyperreactivity (HRBNS) assessed by a positive methacholine test
- FEV1 value > 70% of theoretical FEV1 value
- Asthma Control Test (ACT) ≥ 20/25 in 4 weeks prior to EEC exposure
- Women of childbearing potential should have a negative pregnancy test throughout the study period with effective contraception.
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- Group A:
- Cat allergic asthma (GINA 1, 2) associated with rhinitis and / or conjunctivitis symptoms triggered during an exposure to a cat.
- Positive skin prick-test to cat allergen extract (wheal diameter >3 mm compared to the negative control) Specific immunoglobulin E (IgE) for cat allergen > 0.7 kU/L
- Group B:
- Mild allergic asthma (GINA 1 or 2) not sensitized to cat allergen with associated rhinitis and/or conjunctivitis.
- Negative skin prick-test and specific IgE for cat allergen
- Positive skin prick-test and specific IgE for another allergen.
Who cannot join
- Uncontrolled asthma, ACT asthma control questionnaire less than 20, in the last 4 weeks
- Uncontrolled asthma 2 weeks after interruption of LABA
- Long-term treatment by LABA, within 2 weeks prior to inclusion
- Existence of a severe obstructive syndrome with FEV1 <70% of the theoretical value
- Obstruction triggered by spirometric evaluations
- Hospitalization for asthma or exacerbation in the last 4 weeks
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- Subjects treated with oral corticosteroids in the 4 weeks prior to inclusion in the study
- History of severe acute asthma requiring hospitalization in intensive care or intubation
- Subjects treated with biotherapy in the 4 months prior to inclusion in the study
- Presence of a cat at home, or daily exposure to cat allergens
- Desensitization to cat allergens in the last 6 months
- Active tobacco: plus 10 cigarettes / day or tobacco history plus 10 PA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation Study of the ALYATEC Allergen Exposure Chamber (EEC) by Determining the Concentration of Cat Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Cat
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, during allergen exposures in the Alyatec environmental exposure chamber (EEC).
The study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne cat allergen in Alyatec EEC.
- Conditions
- Allergic Asthma, Allergy, Allergy to Cats
- Being tested
- Exposure to Placebo, Exposure to dose A and dose B of cat allergen, Exposure to a single dose of cat allergen
- Keywords
- Cat allergy, Allergic rhinitis, Allergy
- Medical subject headings
- Hypersensitivity, Rhinitis, Allergic
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 placebo in the EEC
Exposure to dose A and dose B of cat allergenOther
Patients are exposed to dose A and B for successive exposures in the EEC
Exposure to a single dose of cat allergenOther
Patients are exposed to a single dose of cat allergen in the EEC according to the dose selected to achieve the main objective (dose A or B)
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic subjects allergic to cat | Experimental | Group A will be randomized into 2 subgroups of 10 subjects: group A1 and A2. Both subgroupes will be exposed to placebo on exposure 1 then Subgroup A1 will be exposed to dose A on exposure 2 and dose B on exposure 3. Subgroup A2 will be exposed to dose B on exposure 2 and dose A on exposure 3. Dose A and B correspond to different Allergen concentration in the EEC. Receives: Other: Exposure to Placebo; Other: Exposure to dose A and dose B of cat allergen |
| Asthmatic allergic subjects not sensitized to cat | Active comparator | Group B will be exposed to placebo at exposure 1, and then at exposure 2, the concentration of cat allergens corresponding to the dose that achieved the main objective (Dose A or B). Receives: Other: Exposure to Placebo; Other: Exposure to a single dose of cat allergen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the concentration of cat allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to cat.
The bronchial response is evaluated by measuring FEV1 value.
Early asthmatic response (EAR) occurs when a 20 percent drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1.
Late bronchial response (LAR) occurs when a 15 percent drop in FEV1 or 20 percent drop in peak flow is detected 1 to 6h after the EAR.
Measured: 10 hours: 4 hours of exposure in EEC then 6 hours post-exposure
Secondary outcomes (5)
Evaluate the safety of allergenic exposure in EEC
Safety is assessed with an asthma symptom self-report questionnaire performed during the 4h exposure and for 24h after the end of the exposure.
The score was obtained from the sum of all four individual symptom scores (chest tightness, cough, wheezing and dyspnea) with a total possible score ranging from 0 (no symptoms) to 16 (maximum symptom intensity).
Measured: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Evaluate the allergen concentration in the EEC
The measurement of allergen concentration is performed with several sensors positioned in the chamber.
Measured: 4 hours exposure in EEC
Evaluate the specificity of the bronchial response
The specificity of the bronchial response is assessed with the exposure to cat allergen in the EEC of asthmatic allergic subjects non sensitized to cat.
Measured: 4 hours exposure in EEC
Evaluate the effect of the exposure on rhinitis symptoms
The effect of the exposure on the rhinitis response is assessed with Total Nasal Symptom Score (TNSS).
The TNSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity).
Measured: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Evaluate the effect of the exposure on conjunctivitis symptoms
The effect of the exposure on the conjunctivitis response is assessed with Total Ocular Symptom Score (TOSS).
The TOSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity).
Measured: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start10 Apr 2017
- Primary completion15 Jun 2017
- Study completion11 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double blind, cross-over study including two study groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 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
- NCT04678063
- Sponsor's protocol ID
- ALY-003
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 21 Dec 2020
- 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 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of the ALYATEC Allergen Exposure Chamber (EEC) by Determining the Concentration of Cat Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Cat
- ClinicalTrials.gov ID
- NCT04678063
- Acronym / sponsor ID
- ALY-003
- Conditions
- Allergic Asthma, Allergy, Allergy to Cats
- Keywords
- Cat allergy, Allergic rhinitis, Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AlyatecIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 11 Jul 2017 (actual)
- First posted
- 21 Dec 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 randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, during allergen exposures in the Alyatec environmental exposure chamber (EEC).
The study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne cat allergen in Alyatec EEC.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double blind, cross-over study including two study groups
| Arm | Type | Receives |
|---|---|---|
| Asthmatic subjects allergic to cat | Experimental | Other: Exposure to Placebo, Other: Exposure to dose A and dose B of cat allergenGroup A will be randomized into 2 subgroups of 10 subjects: group A1 and A2. Both subgroupes will be exposed to placebo on exposure 1 then Subgroup A1 will be exposed to dose A on exposure 2 and dose B on exposure 3. Subgroup A2 will be exposed to dose B on exposure 2 and dose A on exposure 3. Dose A and B correspond to different Allergen concentration in the EEC. |
| Asthmatic allergic subjects not sensitized to cat | Active comparator | Other: Exposure to Placebo, Other: Exposure to a single dose of cat allergenGroup B will be exposed to placebo at exposure 1, and then at exposure 2, the concentration of cat allergens corresponding to the dose that achieved the main objective (Dose A or B). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects having signed the informed consent
- Subjects affiliated to a social security scheme
- Non-specific bronchial hyperreactivity (HRBNS) assessed by a positive methacholine test
- FEV1 value > 70% of theoretical FEV1 value
- Asthma Control Test (ACT) ≥ 20/25 in 4 weeks prior to EEC exposure
Key exclusion criteria (12 listed)
- Uncontrolled asthma, ACT asthma control questionnaire less than 20, in the last 4 weeks
- Uncontrolled asthma 2 weeks after interruption of LABA
- Long-term treatment by LABA, within 2 weeks prior to inclusion
- Existence of a severe obstructive syndrome with FEV1 <70% of the theoretical value
- Obstruction triggered by spirometric evaluations
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 placebo in the EEC | Other | Asthmatic allergic subjects not sensitized to cat, Asthmatic subjects allergic to cat |
| Exposure to dose A and dose B of cat allergenPatients are exposed to dose A and B for successive exposures in the EEC | Other | Asthmatic subjects allergic to cat |
| Exposure to a single dose of cat allergenPatients are exposed to a single dose of cat allergen in the EEC according to the dose selected to achieve the main objective (dose A or B) | Other | Asthmatic allergic subjects not sensitized to cat |
Primary outcome
Determine the concentration of cat allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to cat.
Time frame: 10 hours: 4 hours of exposure in EEC then 6 hours post-exposure
The bronchial response is evaluated by measuring FEV1 value. Early asthmatic response (EAR) occurs when a 20 percent drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1. Late bronchial response (LAR) occurs when a 15 percent drop in FEV1 or 20 percent drop in peak flow is detected 1 to 6h after the EAR.
5 secondary outcomes
Evaluate the safety of allergenic exposure in EEC
Time frame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Evaluate the allergen concentration in the EEC
Time frame: 4 hours exposure in EEC
Evaluate the specificity of the bronchial response
Time frame: 4 hours exposure in EEC
Evaluate the effect of the exposure on rhinitis symptoms
Time frame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Evaluate the effect of the exposure on conjunctivitis symptoms
Time frame: 28 hours: 4 hours of exposure in EEC then 24 hours post-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 21 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 dose A and dose B of cat allergen and Exposure to a single dose of cat allergen in people with Allergic Asthma and Allergy, 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 13 inclusion and 12 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 21 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 cat allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to cat. (time frame: 10 hours: 4 hours of exposure in EEC then 6 hours post-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 21 Dec 2020.