Allergic AsthmaNCT04663880
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Mite Allergic Subjects With Asthma
A study testing Exposure to three concentrations of HDM allergen in EEC and Exposure to a single concentration of HDM allergen in EEC in people with Allergic Asthma and Allergy to House Dust, 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 house dust mite allergen inducing bronchial response in asthmatic subjects allergic to mite, during allergen exposures in the Alyatec environmental exposure chamber (EEC). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Asthma, Allergy to House Dust, Allergy
- What is being tested?
- Exposure to three concentrations of HDM allergen in EEC and Exposure to a single concentration of HDM allergen in EEC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2016to 15 Feb 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects having signed the informed consent
- Subjects affiliated to a social security scheme
- Positive metacholine test
- FEV1 value > 70% of theoretical FEV1 value
- Asthma Control Test (ACT) ≥ 20/25 in 4 weeks prior to EEC exposure
- Group A:
Show all 13Show fewer
- Mild allergic asthma to HDM (GINA 1 or 2) with associated rhinitis and/or conjunctivitis.
- Positive skin prick-test to Dpt and Df (wheal diameter >5 mm compared to the negative control)
- Specific immunoglobulin E (IgE) for Dpt and Df > 0.7 kU/L
- Group B:
- Mild allergic asthma (GINA 1 or 2) not sensitized to HDM with associated rhinitis and/or conjunctivitis.
- Negative skin prick-test and specific IgE for Dpt and Df.
- Positive skin prick-test and specific IgE for another allergen.
Who cannot join
- Uncontrolled asthma
- Asthma Control Test (ACT) < 20/25 in 4 weeks prior to EEC exposure
- 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
- Existence of a severe obstructive syndrome with FEV1 <70% of the theoretical value
- Obstruction triggered by spirometric evaluations
Show all 20Show fewer
- Hospitalization for asthma or exacerbation in the last 4 weeks
- History of Acute Severe Asthma requiring hospitalization in intensive care or intubation
- Desensitization to dust mite allergens in the last 5 years
- Sensitization to allergens in the indoor environment (cat allergens or molds) with obvious exposure to these allergens
- Active tobacco: plus 10 cigarettes / day and tobacco history of +10 PA
- Uncontrolled systemic arterial hypertension
- Recent myocardial infarction (<3 months)
- Recent stroke (<3 months)
- Known arterial aneurysm
- Epilepsy under treatment
- Progressive tumor pathology
- Chronic renal pathology
- Hypersensitivity to one of the excipients used
- Subjects who participated in another clinical study in the three months prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation Study of the ALYATEC Allergen Exposure Chamber by Determining the Concentration of House Dust Mite Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Mite
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne house dust mite allergen inducing bronchial response in asthmatic subjects allergic to mite, 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 house dust mite allergen in Alyatec EEC.
- Conditions
- Allergic Asthma, Allergy to House Dust, Allergy
- Being tested
- Exposure to placebo in EEC, Exposure to three concentrations of HDM allergen in EEC, Exposure to a single concentration of HDM allergen in EEC
- Keywords
- Allergy, Asthma, House dust mite
- Medical subject headings
- Hypersensitivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to placebo in EECOther
Patients are exposed to placebo (saline solution) in the EEC for 4h maximum
Exposure to three concentrations of HDM allergen in EECOther
Patients are exposed to different concentrations of airborne HDM allergen (Der p1) in the EEC for 4h maximum
Exposure to a single concentration of HDM allergen in EECOther
Patients are exposed to a single concentration of airborne HDM allergen (Der p1) in the EEC for 4h maximum
| Study group | Role | What they receive |
|---|---|---|
| Asthmatic subjects allergic to house dust mite | Experimental | 24 subjects were randomized in a doubleblinded manner into six subgroups. All were exposed first to placebo then in cross over to three different Der p1 concentrations, respectively 15, 25, and 46 ng/m3. Receives: Other: Exposure to placebo in EEC; Other: Exposure to three concentrations of HDM allergen in EEC |
| Asthmatic subjects not allergic to house dust mite | Active comparator | 13 subjects were exposed first to placebo then to Der p1 concentration of 25 ng/m3. Receives: Other: Exposure to placebo in EEC; Other: Exposure to a single concentration of HDM allergen in EEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the concentration of HDM allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to HDM
The bronchial response is evaluated by measuring FEV1 value during EEC exposure.
Early asthmatic response (EAR) occurs when a 20% drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1.
Late bronchial response (LAR) occurs when a 15% drop in FEV1 or 20% drop in peak flow is detected 1 to 6h after the EAR.
Measured: 10 hours: 4 hours of exposure in the EEC then 6 hours post-exposure.
Secondary outcomes (5)
Evaluate the safety of allergenic exposure in EEC
Safety is assessed with clinical evaluations performed during the 4h of exposure in the EEC
Measured: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Evaluate the metrology of the EEC
The metrology is assessed with the measure of allergen concentration and particules diameter thanks to sensors in the chamber.
Measured: 4 hours of exposure in EEC
Evaluate the specificity of the bronchial response
The specificity of the bronchial response is assessed with the HDM exposure in the EEC of asthmatic subjects non allergic to HDM.
Measured: 4 hours of 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 posted11 Dec 2020
- Study start30 Aug 2016
- Primary completion23 Jan 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 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
- NCT04663880
- Sponsor's protocol ID
- ALY-001
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khayath N, Doyen V, Gherasim A, Radu C, Choual I, Beck N, Jacob A, Schoettel F, Vecellio L, Domis N, de Blay F. Validation of Strasbourg environmental exposure chamber (EEC) ALYATEC(R) in mite allergic subjects with asthma. J Asthma. 2020 Feb;57(2):140-148. doi: 10.1080/02770903.2018.1563902. Epub 2019 Mar 28.
PubMed 30919704
Study at a glance
From the registry record, last updated by the sponsor on 11 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 by Determining the Concentration of House Dust Mite Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Mite
- ClinicalTrials.gov ID
- NCT04663880
- Acronym / sponsor ID
- ALY-001
- Conditions
- Allergic Asthma, Allergy to House Dust, Allergy
- Keywords
- Allergy, Asthma, House dust mite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- AlyatecIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 23 Jan 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 11 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 house dust mite allergen inducing bronchial response in asthmatic subjects allergic to mite, 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 house dust mite allergen in Alyatec EEC.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind, cross-over study including two study groups
| Arm | Type | Receives |
|---|---|---|
| Asthmatic subjects allergic to house dust mite | Experimental | Other: Exposure to placebo in EEC, Other: Exposure to three concentrations of HDM allergen in EEC24 subjects were randomized in a doubleblinded manner into six subgroups. All were exposed first to placebo then in cross over to three different Der p1 concentrations, respectively 15, 25, and 46 ng/m3. |
| Asthmatic subjects not allergic to house dust mite | Active comparator | Other: Exposure to placebo in EEC, Other: Exposure to a single concentration of HDM allergen in EEC13 subjects were exposed first to placebo then to Der p1 concentration of 25 ng/m3. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects having signed the informed consent
- Subjects affiliated to a social security scheme
- Positive metacholine test
- FEV1 value > 70% of theoretical FEV1 value
- Asthma Control Test (ACT) ≥ 20/25 in 4 weeks prior to EEC exposure
Key exclusion criteria (20 listed)
- Uncontrolled asthma
- Asthma Control Test (ACT) < 20/25 in 4 weeks prior to EEC exposure
- 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
- Existence of a severe obstructive syndrome with FEV1 <70% of the theoretical value
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 placebo in EECPatients are exposed to placebo (saline solution) in the EEC for 4h maximum | Other | Asthmatic subjects allergic to house dust mite, Asthmatic subjects not allergic to house dust mite |
| Exposure to three concentrations of HDM allergen in EECPatients are exposed to different concentrations of airborne HDM allergen (Der p1) in the EEC for 4h maximum | Other | Asthmatic subjects allergic to house dust mite |
| Exposure to a single concentration of HDM allergen in EECPatients are exposed to a single concentration of airborne HDM allergen (Der p1) in the EEC for 4h maximum | Other | Asthmatic subjects not allergic to house dust mite |
Primary outcome
Determine the concentration of HDM allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to HDM
Time frame: 10 hours: 4 hours of exposure in the EEC then 6 hours post-exposure.
The bronchial response is evaluated by measuring FEV1 value during EEC exposure. Early asthmatic response (EAR) occurs when a 20% drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1. Late bronchial response (LAR) occurs when a 15% drop in FEV1 or 20% 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 metrology of the EEC
Time frame: 4 hours of exposure in EEC
Evaluate the specificity of the bronchial response
Time frame: 4 hours of 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 11 Dec 2020.
- Results publication: PubMed 30919704Khayath N, Doyen V, Gherasim A, Radu C, Choual I, Beck N, Jacob A, Schoettel F, Vecellio L, Domis N, de Blay F. Validation of Strasbourg environmental exposure chamber (EEC) ALYATEC(R) in mite allergic subjects with asthma. J Asthma. 2020 Feb;57(2):140-148. doi: 10.1080/02770903.2018.1563902. Epub 2019 Mar 28.
- 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 three concentrations of HDM allergen in EEC and Exposure to a single concentration of HDM allergen in EEC in people with Allergic Asthma and Allergy to House Dust, 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 20 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 11 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 HDM allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to HDM (time frame: 10 hours: 4 hours of exposure in the 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?
On the ClinicalTrials.gov record for NCT04663880, which also lists 1 linked publication.
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 11 Dec 2020.