Cat AllergyNCT06691568
Effectiveness of an Air Purifier on Asthmatic and Cat-allergic Subjects in the ALYATEC Environmental Exposure Chamber
A study testing Air purifier in people with Cat Allergy, run by Dyson Technology Ltd at 1 site in France.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of air purifiers in reducing allergy symptoms in patients with a cat allergy. The main question it aims to answer is: If there is a reduction of early asthmatic response (EAR) compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cat Allergy
- What is being tested?
- Air purifier
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2023to 26 Oct 2023
- 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 who signed the written informed consent
- Men or women aged between 18- and 65-year-old
- Subjects covered by health social identification number
- Subjects able to understand and complete study-related procedures
- Subjects reported history of symptomatic cat allergen-triggered asthma (GINA1-2) with or without associated allergic rhinitis and/or conjunctivitis
- Positive skin prick test (SPT) with cat hair extract with mean wheal diameter ≥ 5 mm compared to negative control (NaCl reaction < 2 mm)
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- Subjects with FEV1≥70% predicted at screening and before allergen exposure,
- Subjects with at least one drop in FEV1 ≥ 20% within the 2- hours exposure at baseline (V2)
- Women of childbearing potential with a negative pregnancy test throughout the study period and highly effective contraception: oral contraceptives, condom with spermicide, intrauterine device, bilateral tubal ligation, vasectomized partner.
Who cannot join
- Allergen immunotherapy to cat allergen for more than 1 month in the 3 years prior to the screening visit
- Ongoing allergen immunotherapy to another allergen
- History of anaphylactic reactions to cat allergen exposure or cat allergen immunotherapy
- History of anaphylactic reactions to another allergen in the last 6 weeks before inclusion
- Nasal polyposis, deviation of nasal septum, or diagnosis of uncontrolled non- allergic rhinitis
- Subjects allergic to indoor environmental allergens (molds, house dust mite allergens) with obvious exposure to these allergens causing allergic symptoms
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- No cat exposure at home for the past year and must continue having no exposure at home during the study; cat exposure outside of the home shall be avoided for at least one week prior to any Cat Allergen Challenge
- Subjects with pollen season allergies (birch, grass, ash) will not be able to participate in the study during the pollen season for these allergens
- Conjunctival diseases such as severe keratitis, or other ocular disorders, ocular pain and/or photophobia during pollen season
- Moderate to severe asthma GINA 3 to 5
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the efficacy of air purifiers in reducing allergy symptoms in patients with a cat allergy. The main question it aims to answer is:
If there is a reduction of early asthmatic response (EAR) compared to placebo.
Participants were asked to remain in an exposure chamber for 2 hours while their symptoms were monitored.
Read the detailed description
For this protocol, 30 patients with cat allergies were exposed to 80ng/m3 of Fel d 1 allergen in the ALYATEC Environmental Exposure Chamber (EEC).
The active group of 15 had Dyson BP06 air purifiers running at speed 2, while the placebo group had the purifiers on, but not circulating air (speed 0). Participants were monitored for the primary objective of reduction of EAR, alongside other secondary objectives:
- To evaluate the efficacy of air purifier on time to induce EAR during a 2-hour cat allergen exposure in ALYATEC EEC compared to placebo
- To evaluate the efficacy of air purifier on allergic rhino-conjunctivitis symptoms during a 2-hour cat allergen exposure in ALYATEC EEC compared to a placebo
- To evaluate the efficacy of air purifier on bronchial response severity during a 2-hour cat allergen exposure in ALYATEC EEC compared to placebo.
- To evaluate the rescue treatments used after 2-hour cat allergen exposure with the air purifier compared to placebo
- To evaluate the efficacy of air purifier on allergic rhinitis symptoms during a 2-hour cat allergen exposure in ALYATEC EEC compared to a placebo
- Conditions
- Cat Allergy
- Being tested
- Air purifier
- Keywords
- Cat allergy, EAR, Asthma, Purifier
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air purifierDevice
Purifiers were turned on for the active group and off for the placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Purifiers were active during cat allergen exposure Receives: Device: Air purifier |
| Placebo | Placebo comparator | Purifiers were inactive during cat allergen exposure Receives: Device: Air purifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the efficacy of air purifier on reducing the frequency of early asthmatic response (EAR) during a 2-hour cat allergen exposure in ALYATEC EEC compared to placebo.
Comparing the number of subjects with a drop in FEV1≥ 20% within the 2-hour exposure
Measured: Within the 2 hour exposure period
Secondary outcomes (2)
To evaluate the efficacy of air purifier on time to induce EAR during a 2-hour cat allergen exposure in ALYATEC EEC compared to placebo
Measured: Within the 2 hour exposure period
To evaluate the efficacy of air purifier on allergic rhino-conjunctivitis symptoms during a 2-hour cat allergen exposure in ALYATEC EEC compared to a placebo
Measured: Within the 2 hour exposure period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start20 Jan 2023
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
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 Cat AllergyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dyson Technology Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alyatec
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691568
- Sponsor's protocol ID
- 664E-BP06-001
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gherasim A, Dietsch F, Odul F, Riff T, Domis N, de Blay F. Efficacy of air cleaners to reduce allergic responses to cat: A randomized clinical trial using an environmental exposure chamber. Respir Med. 2025 Jun;242:108105. doi: 10.1016/j.rmed.2025.108105. Epub 2025 Apr 15.
PubMed 40246248
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Air Purifier on Asthmatic and Cat-allergic Subjects in the ALYATEC Environmental Exposure Chamber
- ClinicalTrials.gov ID
- NCT06691568
- Acronym / sponsor ID
- 664E-BP06-001
- Conditions
- Cat Allergy
- Keywords
- Cat allergy, EAR, Asthma, Purifier
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dyson Technology LtdIndustry (pharma, biotech, devices)
- Collaborators
- Alyatec
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 15 Nov 2024 (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 goal of this clinical trial is to evaluate the efficacy of air purifiers in reducing allergy symptoms in patients with a cat allergy. The main question it aims to answer is:
If there is a reduction of early asthmatic response (EAR) compared to placebo.
Participants were asked to remain in an exposure chamber for 2 hours while their symptoms were monitored.
Detailed description
For this protocol, 30 patients with cat allergies were exposed to 80ng/m3 of Fel d 1 allergen in the ALYATEC Environmental Exposure Chamber (EEC).
The active group of 15 had Dyson BP06 air purifiers running at speed 2, while the placebo group had the purifiers on, but not circulating air (speed 0). Participants were monitored for the primary objective of reduction of EAR, alongside other secondary objectives:
- To evaluate the efficacy of air purifier on time to induce EAR during a 2-hour cat allergen exposure in ALYATEC EEC compared to placebo
- To evaluate the efficacy of air purifier on allergic rhino-conjunctivitis symptoms during a 2-hour cat allergen exposure in ALYATEC EEC compared to a placebo
- To evaluate the efficacy of air purifier on bronchial response severity during a 2-hour cat allergen exposure in ALYATEC EEC compared to placebo.
- To evaluate the rescue treatments used after 2-hour cat allergen exposure with the air purifier compared to placebo
- To evaluate the efficacy of air purifier on allergic rhinitis symptoms during a 2-hour cat allergen exposure in ALYATEC EEC compared to a placebo
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Air purifierPurifiers were active during cat allergen exposure |
| Placebo | Placebo comparator | Device: Air purifierPurifiers were inactive during cat allergen exposure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who signed the written informed consent
- Men or women aged between 18- and 65-year-old
- Subjects covered by health social identification number
- Subjects able to understand and complete study-related procedures
- Subjects reported history of symptomatic cat allergen-triggered asthma (GINA1-2) with or without associated allergic rhinitis and/or conjunctivitis
Key exclusion criteria (10 listed)
- Allergen immunotherapy to cat allergen for more than 1 month in the 3 years prior to the screening visit
- Ongoing allergen immunotherapy to another allergen
- History of anaphylactic reactions to cat allergen exposure or cat allergen immunotherapy
- History of anaphylactic reactions to another allergen in the last 6 weeks before inclusion
- Nasal polyposis, deviation of nasal septum, or diagnosis of uncontrolled 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 |
|---|---|---|
| Air purifierPurifiers were turned on for the active group and off for the placebo | Device | Active, Placebo |
Primary outcome
To measure the efficacy of air purifier on reducing the frequency of early asthmatic response (EAR) during a 2-hour cat allergen exposure in ALYATEC EEC compared to placebo.
Time frame: Within the 2 hour exposure period
Comparing the number of subjects with a drop in FEV1≥ 20% within the 2-hour exposure
2 secondary outcomes
To evaluate the efficacy of air purifier on time to induce EAR during a 2-hour cat allergen exposure in ALYATEC EEC compared to placebo
Time frame: Within the 2 hour exposure period
To evaluate the efficacy of air purifier on allergic rhino-conjunctivitis symptoms during a 2-hour cat allergen exposure in ALYATEC EEC compared to a placebo
Time frame: Within the 2 hour exposure period
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 15 Nov 2024.
- Derived from this study: PubMed 40246248Gherasim A, Dietsch F, Odul F, Riff T, Domis N, de Blay F. Efficacy of air cleaners to reduce allergic responses to cat: A randomized clinical trial using an environmental exposure chamber. Respir Med. 2025 Jun;242:108105. doi: 10.1016/j.rmed.2025.108105. Epub 2025 Apr 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air purifier in people with Cat Allergy, run by Dyson Technology Ltd 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 9 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 15 Nov 2024. 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?
To measure the efficacy of air purifier on reducing the frequency of early asthmatic response (EAR) during a 2-hour cat allergen exposure in ALYATEC EEC compared to placebo. (time frame: Within the 2 hour exposure period). 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 NCT06691568, 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 15 Nov 2024.