AsthmaNCT03928561
Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber
A study testing Active intense Pure Air XL air cleaner in people with Asthma and Allergy, run by Alyatec at 1 site in France.
Trial summary
The aim of this study is to determine the efficacy of Rowenta® "Intense Pure Air XL" air cleaner on the early and late bronchial response, in cat-allergic asthmatic patients during an allergen exposure in ALYATEC environmental chamber (EEC) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Active intense Pure Air XL air cleaner
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2017to 19 Feb 2018
- 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
- Controlled intermittent asthma (step 1 treatment, according to GINA Guideline 2016) with or without association with cat allergy related rhino-conjunctivitis;
- Sensitization to cat allergen extract as defined by skin prick test for cat extract with a wheal diameter of ≥3 mm greater than negative control (ALK, HØrsholm, Denmark) and specific IgE anti Fel d 1 ≥ 0.7 kU/L ( ImmunoCAP, Thermofisher, Uppsala, Sweden);
- FEV1 ≥ 70% of the predicted value;
- No cat exposure at home or outside of the home during the study;
- Positive methacholine challenge test performed using an AeroDoseur DTF-Atomisor ATO-AD 12 (Saint-Etienne, France);
- Early asthmatic response during baseline cat allergen exposure.
Who cannot join
- Uncontrolled asthma, asthma control test inferior to 20 within the 4 weeks preceding the study.
- Uncontrolled asthma 2 weeks after stopping LABA treatment.
- LABA treatment within the 2 weeks preceding the study.
- Severe asthma (> GINA 2)
- Subject lives with a cat
- Cat desensibilisation within the 6 previous months.
- Active smoker
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the efficacy of Rowenta® "Intense Pure Air XL" air cleaner on the early and late bronchial response, in cat-allergic asthmatic patients during an allergen exposure in ALYATEC environmental chamber (EEC)
Read the detailed description
A monocentric, double-blind, placebo-controlled, cross-over study conducted outside of the pollen season. The study lasts 3 months for each patient, which includes a screening period, two exposure visits in the Alyatec Environmental Exposure Chamber (EEC) with active or placebo air cleaners, and a follow-up visit.
Patients with early asthmatic reaction during baseline exposure are randomly allocated to one of two sequences: active air cleaners /placebo or placebo/active air cleaners. Randomization is balanced (1:1) between the two sequences. There is a 3-week wash-out period between the two exposures.
- Being tested
- Active intense Pure Air XL air cleaner, Placebo Intense Pure Air XL air cleaner
- Keywords
- Asthma, Cat allergy, Environmental Exposure Chamber, Air cleaner
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active intense Pure Air XL air cleanerDevice
Cat allergen is nebulized in the EEC. When the concentration is stable, air cleaners are switched on. The number of air cleaners placed in the EEC is defined according to the volume of the EEC and the air renewal. Patients are exposed to cat allergen in the presence of active air cleaners in the EEC
Placebo Intense Pure Air XL air cleanerDevice
Cat allergen is nebulized in the EEC. When the concentration is stable, placebo air cleaners are switched on. The placebo effect is obtained thanks to the removal of air cleaners filters prior to the exposure. The number of placebo air cleaners placed in the EEC is defined according to the volume of the EEC and the air renewal. Patients are exposed to cat allergen in the presence of placebo air cleaners in the EEC.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Active air cleaner then Placebo | Experimental | Exposure to cat allergen in the presence of active air cleaners then placebo. 3-week wash-out period between the two exposures. Receives: Device: Active intense Pure Air XL air cleaner; Device: Placebo Intense Pure Air XL air cleaner |
| 2 - Placebo then active air cleaner | Experimental | Exposure to cat allergen in the presence of placebo then active air cleaners. 3-week wash-out period between the two exposures. Receives: Device: Active intense Pure Air XL air cleaner; Device: Placebo Intense Pure Air XL air cleaner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of early asthmatic response
In subjects exposed in the EEC to an average cat allergen concentration of 40 ng/m3 (Feld1) in presence of an active air cleaner compared to a placebo.
Early asthmatic response is defined by a drop of at least 20% compared to baseline FEV1.
Measured: Week 9
Secondary outcomes (8)
Frequency of late asthmatic response
Late asthmatic response is defined by a 15% drop of FEV1 compared to baseline FEV1 between 1h and 6h after the end of the allergen exposure.
Measured: Week 9
Severity of early and/or late asthmatic response
Evaluated by the maximum percentage of drop in FEV1. It was measured in subjects exposed to cat allergen with active air cleaners compared to placebo air cleaners.
Measured: Week 9
Difference of asthma symptoms during exposure to cat allergen with active air cleaners versus placebo.
The intensity of asthma symptoms is assessed using the visual analogue scale (VAS). The VAS is based on one question which allows to evaluate the symptoms on a scale from 0 to 10. 0 means no symptoms (best condition) and 10 means high symptoms (worse condition).
Measured: Week 9
Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
The intensity of rhinitis symptoms is assessed using the TNSS (Total Nasal Symptom Score) nasal self-assessment questionnaire. The score of the TNSS varies from 0 (no symptoms) to 12 (high symptoms).
Measured: Week 9
Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
The intensity of rhinitis symptoms is assessed using the visual analogue scale (VAS). The VAS is based on one question which allows to evaluate the symptoms on a scale from 0 to 10. 0 means no symptoms (best condition) and 10 means high symptoms (worse condition). A difference of 23 mm between two assessments done before and after exposure is considered as clinically significant.
Measured: Week 9
Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
The intensity of conjunctivitis symptoms is assessed using the TOSS (Total Ocular Symptom Score) conjunctival self-assessment questionnaire. It varies between 0 (no symptoms) and 6 (high symptoms).
Measured: Week 9
Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
The intensity of conjunctivitis symptoms is assessed using the visual analogue scale (conjunctivitis VAS). The VAS is based on one question which allows to evaluate the symptoms on a scale from 0 (no symptoms) to 10 (high symptoms).
Measured: Week 9
Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
The intensity of conjunctivitis symptoms is assessed using Abelson's Score. Abelson's score varies from 0 (no symptoms) to 13 (higher symptoms). A positive conjunctival response is defined by Albelson's Score evaluated by physician above or equal to 5 during allergen exposure.
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start6 Dec 2017
- Primary completion30 Jan 2018
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, cross-over, double-blind placebo-controlled study including 24 cat-asthmatic patients with GINA 1 asthma.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alyatec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric de Blay, MD, Principal investigator, Strasbourg University Hospital - Alyatec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928561
- Sponsor's protocol ID
- SEB-001
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 16 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 30919704Gherasim A, Jacob A, Schoettel F, Domis N, de Blay F. Efficacy of air cleaners in asthmatics allergic to cat in ALYATEC(R) environmental exposure chamber. Clin Exp Allergy. 2020 Feb;50(2):160-169. doi: 10.1111/cea.13511. Epub 2019 Nov 6.
PubMed 31596983
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
- Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT03928561
- Acronym / sponsor ID
- SEB-001
- Keywords
- Asthma, Cat allergy, Environmental Exposure Chamber, Air cleaner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AlyatecIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 26 Apr 2019 (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 determine the efficacy of Rowenta® "Intense Pure Air XL" air cleaner on the early and late bronchial response, in cat-allergic asthmatic patients during an allergen exposure in ALYATEC environmental chamber (EEC)
Detailed description
A monocentric, double-blind, placebo-controlled, cross-over study conducted outside of the pollen season. The study lasts 3 months for each patient, which includes a screening period, two exposure visits in the Alyatec Environmental Exposure Chamber (EEC) with active or placebo air cleaners, and a follow-up visit.
Patients with early asthmatic reaction during baseline exposure are randomly allocated to one of two sequences: active air cleaners /placebo or placebo/active air cleaners. Randomization is balanced (1:1) between the two sequences. There is a 3-week wash-out period between the two exposures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, cross-over, double-blind placebo-controlled study including 24 cat-asthmatic patients with GINA 1 asthma.
| Arm | Type | Receives |
|---|---|---|
| 1 - Active air cleaner then Placebo | Experimental | Device: Active intense Pure Air XL air cleaner, Device: Placebo Intense Pure Air XL air cleanerExposure to cat allergen in the presence of active air cleaners then placebo. 3-week wash-out period between the two exposures. |
| 2 - Placebo then active air cleaner | Experimental | Device: Active intense Pure Air XL air cleaner, Device: Placebo Intense Pure Air XL air cleanerExposure to cat allergen in the presence of placebo then active air cleaners. 3-week wash-out period between the two exposures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Controlled intermittent asthma (step 1 treatment, according to GINA Guideline 2016) with or without association with cat allergy related rhino-conjunctivitis;
- Sensitization to cat allergen extract as defined by skin prick test for cat extract with a wheal diameter of ≥3 mm greater than negative control (ALK, HØrsholm, Denmark) and specific IgE anti Fel d 1 ≥ 0.7 kU/L ( ImmunoCAP, Thermofisher, Uppsala, Sweden);
- FEV1 ≥ 70% of the predicted value;
- No cat exposure at home or outside of the home during the study;
- Positive methacholine challenge test performed using an AeroDoseur DTF-Atomisor ATO-AD 12 (Saint-Etienne, France);
Key exclusion criteria (7 listed)
- Uncontrolled asthma, asthma control test inferior to 20 within the 4 weeks preceding the study.
- Uncontrolled asthma 2 weeks after stopping LABA treatment.
- LABA treatment within the 2 weeks preceding the study.
- Severe asthma (> GINA 2)
- Subject lives with a cat
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 |
|---|---|---|
| Active intense Pure Air XL air cleanerCat allergen is nebulized in the EEC. When the concentration is stable, air cleaners are switched on. The number of air cleaners placed in the EEC is defined according to the volume of the EEC and the air renewal. Patients are exposed to cat allergen in the presence of active air cleaners in the EEC | Device | 1 - Active air cleaner then Placebo, 2 - Placebo then active air cleaner |
| Placebo Intense Pure Air XL air cleanerCat allergen is nebulized in the EEC. When the concentration is stable, placebo air cleaners are switched on. The placebo effect is obtained thanks to the removal of air cleaners filters prior to the exposure. The number of placebo air cleaners placed in the EEC is defined according to the volume of the EEC and the air renewal. Patients are exposed to cat allergen in the presence of placebo air cleaners in the EEC. | Device | 1 - Active air cleaner then Placebo, 2 - Placebo then active air cleaner |
Primary outcome
Frequency of early asthmatic response
Time frame: Week 9
In subjects exposed in the EEC to an average cat allergen concentration of 40 ng/m3 (Feld1) in presence of an active air cleaner compared to a placebo. Early asthmatic response is defined by a drop of at least 20% compared to baseline FEV1.
8 secondary outcomes
Frequency of late asthmatic response
Time frame: Week 9
Severity of early and/or late asthmatic response
Time frame: Week 9
Difference of asthma symptoms during exposure to cat allergen with active air cleaners versus placebo.
Time frame: Week 9
Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
Time frame: Week 9
Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
Time frame: Week 9
Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
Time frame: Week 9
Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
Time frame: Week 9
Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
Time frame: Week 9
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.
- Background: 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.
- Derived from this study: PubMed 31596983Gherasim A, Jacob A, Schoettel F, Domis N, de Blay F. Efficacy of air cleaners in asthmatics allergic to cat in ALYATEC(R) environmental exposure chamber. Clin Exp Allergy. 2020 Feb;50(2):160-169. doi: 10.1111/cea.13511. Epub 2019 Nov 6.
- 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, MD principal investigator
Strasbourg University Hospital - 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 Active intense Pure Air XL air cleaner in people with 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 6 inclusion and 7 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?
Frequency of early asthmatic response (time frame: Week 9). 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 NCT03928561, which also lists 2 linked publications.
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.