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

Not Applicable

Terminated

• Conditions: Asthma
• Interventions: Device: Acar'up placebo system; Device: Acar'up system

• Registration Number: NCT02773628
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-04-25
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-16
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Acar'up placebo system	stable asthmatics receiving an Acar'up placebo system
treatment group	Acar'up system	stable asthmatics receiving Acar'up system

Primary Outcome Measures

Name	Time	Method
assessment of successful stepdown of inhaled corticosteroid using asthma scale: asthma control questionnaire (ACQ)	4 months	assessment of the successful step down of inhaled corticosteroid using asthma scale: asthma control questionnaire (ACQ)
assessment of successful stepdown of inhaled corticosteroid using asthma quality of life questionnaire (AQLQ)	4 months	assessment of the successful step down of inhaled corticosteroid using asthma quality of life questionnaire (AQLQ)
assessment of successful stepdown of inhaled corticosteroid using clinical evaluation	4 months	assessment of the successful step down of inhaled corticosteroid using clinical evaluation

Secondary Outcome Measures

Name	Time	Method
assessment of asthma control by the asthma control questionnaire questionnaire	4 months	by the asthma control questionnaire
assessment of rhinitis control by the rhinitis quality of life questionnaire	4 months	by the rhinitis quality of life questionnaire
assessment of asthma quality of life by the asthma quality of life questionnaire	4 months	by the asthma quality of life questionnaire

Trial Locations

Locations (1)

CHu Saint Pierre; 🇧🇪 Brussels, Belgium