Clinical trial NCT03928561: Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber
Official title: Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Allergy
Keywords: Asthma
Cat allergy
Environmental Exposure Chamber
Air cleaner
Lead sponsor: Alyatec
Sponsor class: INDUSTRY
First posted: 2019-04-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, cross-over, double-blind placebo-controlled study including 24 cat-asthmatic patients with GINA 1 asthma.
Primary purpose: PREVENTION

Brief 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)

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Frequency of early asthmatic response
timeFrame: Week 9
Secondary outcomes:
measure: Frequency of late asthmatic response
timeFrame: Week 9
measure: Severity of early and/or late asthmatic response
timeFrame: Week 9
measure: Difference of asthma symptoms during exposure to cat allergen with active air cleaners versus placebo.
timeFrame: Week 9
measure: Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
timeFrame: Week 9
measure: Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
timeFrame: Week 9
measure: Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
timeFrame: Week 9
measure: Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
timeFrame: Week 9
measure: Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
timeFrame: Week 9
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Alyatec
state: Bas-Rhin
Study officials:
affiliation: Strasbourg University Hospital - Alyatec
name: Frédéric de Blay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Gherasim 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.