Impact of Reduction of Dust Mite Allergenic Load on Step Down of Inhaled Corticosteroids in Stable Asthma

Study Overview
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Brief Summary
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Eviction methods for dust mite allergy have been evaluated in asthma control in a recent Cochrane meta-analysis. None have shown efficacy on asthma control and there are not recommended. The purpose is to evaluate the efficacy of a new commercialized system (Acar'Up) to decrease dust mite load and to assess its impact on the possibility to perform inhaled corticosteroids step down in stable asthmatics.

Detailed Description
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Eviction methods for dust mite allergy have been evaluated in asthma control in a recent Cochrane meta-analysis. None have shown efficacy on asthma control and there are not recommended. The purpose is to evaluate the efficacy of a new commercialized system, Acar'Up (a spray pulverized on a technical textile that traps the dust mite) to decrease dust mite load and to assess its impact on the possibility to perform inhaled corticosteroids step down in stable asthmatics.

Official Title
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Impact of Reduction of Dust Mite Allergenic Load on Step Down of Inhaled Corticosteroids in Stable Asthma

Conditions
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Asthma

Intervention / Treatment
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* Device: Acar'up system
* Device: Acar'up placebo system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed asthma diagnosis controlled asthma for more than 3 months treatment with inhaled corticosteroids dust mite allergy proved by skin tests ou specific immunoglobulin E Exclusion Criteria: chronic obstructive pulmonary disease, bronchiectasis, Fibrosis, tuberculosis asthma-chronic obstructive pulmonary disease overlap syndrome ongoing desensitization for dust mite pregnancy previous use of Acar'up

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>stable asthmatics receiving an Acar'up placebo system | Device: Acar'up placebo system<br> <br> |
| Active Comparator: treatment group<br>stable asthmatics receiving Acar'up system | Device: Acar'up system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of successful stepdown of inhaled corticosteroid using clinical evaluation | assessment of the successful step down of inhaled corticosteroid using clinical evaluation | 4 months | 
| assessment of successful stepdown of inhaled corticosteroid using asthma scale: asthma control questionnaire (ACQ) | assessment of the successful step down of inhaled corticosteroid using asthma scale: asthma control questionnaire (ACQ) | 4 months | 
| assessment of successful stepdown of inhaled corticosteroid using asthma quality of life questionnaire (AQLQ) | assessment of the successful step down of inhaled corticosteroid using asthma quality of life questionnaire (AQLQ) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of asthma control by the asthma control questionnaire questionnaire | by the asthma control questionnaire | 4 months | 
| assessment of asthma quality of life by the asthma quality of life questionnaire | by the asthma quality of life questionnaire | 4 months | 
| assessment of rhinitis control by the rhinitis quality of life questionnaire | by the rhinitis quality of life questionnaire | 4 months |