Effectiveness of an Air Purifier on Asthmatic and Cat-allergic Subjects in the ALYATEC Environmen… (NCT06691568) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of an Air Purifier on Asthmatic and Cat-allergic Subjects in the ALYATEC Environmental Exposure Chamber
France30 participantsStarted 2023-01-20
Plain-language 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.
Participants were asked to remain in an exposure chamber for 2 hours while their symptoms were monitored.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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)
* 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.
Exclusion Criteria:
* 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 allerge…
What they're measuring
1
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.