Back to resultsEfficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber
Primary Purpose
Asthma, Allergy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Active intense Pure Air XL air cleaner
Placebo Intense Pure Air XL air cleaner
Sponsored by
About this trial
This is an interventional prevention trial for Asthma focused on measuring Asthma, Cat allergy, Environmental Exposure Chamber, Air cleaner
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
Sites / Locations
- Alyatec
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1 - Active air cleaner then Placebo
2 - Placebo then active air cleaner
Arm Description
Exposure to cat allergen in the presence of active air cleaners then placebo. 3-week wash-out period between the two exposures.
Exposure to cat allergen in the presence of placebo then active air cleaners. 3-week wash-out period between the two exposures.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Frequency of late asthmatic response
Late asthmatic response is defined by a 15% drop of FEV1 compared to baseline FEV1 between 1h and 6h after the end of the allergen exposure.
Severity of early and/or late asthmatic response
Evaluated by the maximum percentage of drop in FEV1. It was measured in subjects exposed to cat allergen with active air cleaners compared to placebo air cleaners.
Difference of asthma symptoms during exposure to cat allergen with active air cleaners versus placebo.
The intensity of asthma symptoms is assessed using the visual analogue scale (VAS). The VAS is based on one question which allows to evaluate the symptoms on a scale from 0 to 10. 0 means no symptoms (best condition) and 10 means high symptoms (worse condition).
Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
The intensity of rhinitis symptoms is assessed using the TNSS (Total Nasal Symptom Score) nasal self-assessment questionnaire. The score of the TNSS varies from 0 (no symptoms) to 12 (high symptoms).
Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
The intensity of rhinitis symptoms is assessed using the visual analogue scale (VAS). The VAS is based on one question which allows to evaluate the symptoms on a scale from 0 to 10. 0 means no symptoms (best condition) and 10 means high symptoms (worse condition). A difference of 23 mm between two assessments done before and after exposure is considered as clinically significant.
Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
The intensity of conjunctivitis symptoms is assessed using the TOSS (Total Ocular Symptom Score) conjunctival self-assessment questionnaire. It varies between 0 (no symptoms) and 6 (high symptoms).
Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
The intensity of conjunctivitis symptoms is assessed using the visual analogue scale (conjunctivitis VAS). The VAS is based on one question which allows to evaluate the symptoms on a scale from 0 (no symptoms) to 10 (high symptoms).
Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
The intensity of conjunctivitis symptoms is assessed using Abelson's Score. Abelson's score varies from 0 (no symptoms) to 13 (higher symptoms). A positive conjunctival response is defined by Albelson's Score evaluated by physician above or equal to 5 during allergen exposure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03928561
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
February 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alyatec
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Allergy
Keywords
Asthma, Cat allergy, Environmental Exposure Chamber, Air cleaner
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, cross-over, double-blind placebo-controlled study including 24 cat-asthmatic patients with GINA 1 asthma.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 - Active air cleaner then Placebo
Arm Type
Experimental
Arm Description
Exposure to cat allergen in the presence of active air cleaners then placebo. 3-week wash-out period between the two exposures.
Arm Title
2 - Placebo then active air cleaner
Arm Type
Experimental
Arm Description
Exposure to cat allergen in the presence of placebo then active air cleaners. 3-week wash-out period between the two exposures.
Intervention Type
Device
Intervention Name(s)
Active intense Pure Air XL air cleaner
Intervention Description
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
Intervention Name(s)
Placebo Intense Pure Air XL air cleaner
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of early asthmatic response
Description
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.
Time Frame
Week 9
Secondary Outcome Measure Information:
Title
Frequency of late asthmatic response
Description
Late asthmatic response is defined by a 15% drop of FEV1 compared to baseline FEV1 between 1h and 6h after the end of the allergen exposure.
Time Frame
Week 9
Title
Severity of early and/or late asthmatic response
Description
Evaluated by the maximum percentage of drop in FEV1. It was measured in subjects exposed to cat allergen with active air cleaners compared to placebo air cleaners.
Time Frame
Week 9
Title
Difference of asthma symptoms during exposure to cat allergen with active air cleaners versus placebo.
Description
The intensity of asthma symptoms is assessed using the visual analogue scale (VAS). The VAS is based on one question which allows to evaluate the symptoms on a scale from 0 to 10. 0 means no symptoms (best condition) and 10 means high symptoms (worse condition).
Time Frame
Week 9
Title
Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
Description
The intensity of rhinitis symptoms is assessed using the TNSS (Total Nasal Symptom Score) nasal self-assessment questionnaire. The score of the TNSS varies from 0 (no symptoms) to 12 (high symptoms).
Time Frame
Week 9
Title
Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
Description
The intensity of rhinitis symptoms is assessed using the visual analogue scale (VAS). The VAS is based on one question which allows to evaluate the symptoms on a scale from 0 to 10. 0 means no symptoms (best condition) and 10 means high symptoms (worse condition). A difference of 23 mm between two assessments done before and after exposure is considered as clinically significant.
Time Frame
Week 9
Title
Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
Description
The intensity of conjunctivitis symptoms is assessed using the TOSS (Total Ocular Symptom Score) conjunctival self-assessment questionnaire. It varies between 0 (no symptoms) and 6 (high symptoms).
Time Frame
Week 9
Title
Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
Description
The intensity of conjunctivitis symptoms is assessed using the visual analogue scale (conjunctivitis VAS). The VAS is based on one question which allows to evaluate the symptoms on a scale from 0 (no symptoms) to 10 (high symptoms).
Time Frame
Week 9
Title
Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.
Description
The intensity of conjunctivitis symptoms is assessed using Abelson's Score. Abelson's score varies from 0 (no symptoms) to 13 (higher symptoms). A positive conjunctival response is defined by Albelson's Score evaluated by physician above or equal to 5 during allergen exposure.
Time Frame
Week 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric de Blay, MD
Organizational Affiliation
Strasbourg University Hospital - Alyatec
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alyatec
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30919704
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.
Results Reference
background
PubMed Identifier
31596983
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.
Results Reference
derived
Learn more about this trial
Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber
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