Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-06

Study Completion Date

2018-02-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Allergy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Asthma Cat allergy Environmental Exposure Chamber Air cleaner

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, cross-over, double-blind placebo-controlled study including 24 cat-asthmatic patients with GINA 1 asthma.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 - Active air cleaner then Placebo

Exposure to cat allergen in the presence of active air cleaners then placebo. 3-week wash-out period between the two exposures.

Group Type EXPERIMENTAL

Active intense Pure Air XL air cleaner

Intervention Type DEVICE

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 cleaner

Intervention Type DEVICE

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.

2 - Placebo then active air cleaner

Exposure to cat allergen in the presence of placebo then active air cleaners. 3-week wash-out period between the two exposures.

Group Type EXPERIMENTAL

Active intense Pure Air XL air cleaner

Intervention Type DEVICE

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 cleaner

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Active intense Pure Air XL air cleaner

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

Intervention Type DEVICE

Placebo Intense Pure Air XL air cleaner

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frédéric de Blay, MD

Role: PRINCIPAL_INVESTIGATOR

Strasbourg University Hospital - Alyatec

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alyatec

Strasbourg, Bas-Rhin, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

PMID: 30919704 (View on PubMed)

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.

Reference Type DERIVED

PMID: 31596983 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SEB-001

Identifier Type: -

Identifier Source: org_study_id

Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1 - Active air cleaner then Placebo

Active intense Pure Air XL air cleaner

Placebo Intense Pure Air XL air cleaner

2 - Placebo then active air cleaner

Active intense Pure Air XL air cleaner

Placebo Intense Pure Air XL air cleaner

Interventions

Active intense Pure Air XL air cleaner

Placebo Intense Pure Air XL air cleaner

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Alyatec

Responsible Party

Principal Investigators

Frédéric de Blay, MD

Locations

Alyatec

Countries

References

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.

Other Identifiers

SEB-001