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

NCT03928561 | Completed

• 1 other identifier: SEB-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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)

Conditions

Asthma; Allergy

Keywords

Asthma; Cat allergy; Environmental Exposure Chamber; Air cleaner

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 9

Secondary Outcomes (8)

• Frequency of late asthmatic response

  Week 9

• Severity of early and/or late asthmatic response

  Week 9

• Difference of asthma symptoms during exposure to cat allergen with active air cleaners versus placebo.

  Week 9

• Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.

  Week 9

• Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.

  Week 9

Study Arms (2)

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.

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.

Device: Active intense Pure Air XL air cleaner; Device: Placebo Intense Pure Air XL air cleaner

Interventions

Active intense Pure Air XL air cleaner 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

1 - Active air cleaner then Placebo; 2 - Placebo then active air cleaner

Placebo Intense Pure Air XL air cleaner 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.

1 - Active air cleaner then Placebo; 2 - Placebo then active air cleaner

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alyatec: lead

Study Sites (1)

Alyatec

Strasbourg, Bas-Rhin, 67000, France

Location

Related Publications (2)

• 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.

  PMID: 30919704 BACKGROUND

• 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.

  PMID: 31596983 DERIVED

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Frédéric de Blay, MD

  Strasbourg University Hospital - Alyatec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 26, 2019
• Study Start: December 6, 2017
• Primary Completion: January 30, 2018
• Study Completion: February 19, 2018
• Last Updated: December 16, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)