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

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ClinicalTrials.gov Identifier: NCT02773628
Recruitment Status : Terminated (methodological concerns about study design)
First Posted : May 16, 2016
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asthma Device: Acar'up system Device: Acar'up placebo system Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Reduction of Dust Mite Allergenic Load on Step Down of Inhaled Corticosteroids in Stable Asthma
Study Start Date : May 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: control group
stable asthmatics receiving an Acar'up placebo system
 Device: Acar'up placebo system
Active Comparator: treatment group
stable asthmatics receiving Acar'up system
 Device: Acar'up system


Outcome Measures
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Primary Outcome Measures :
  1. assessment of successful stepdown of inhaled corticosteroid using clinical evaluation [ Time Frame: 4 months ]
    assessment of the successful step down of inhaled corticosteroid using clinical evaluation

  2. assessment of successful stepdown of inhaled corticosteroid using asthma scale: asthma control questionnaire (ACQ) [ Time Frame: 4 months ]
    assessment of the successful step down of inhaled corticosteroid using asthma scale: asthma control questionnaire (ACQ)

  3. assessment of successful stepdown of inhaled corticosteroid using asthma quality of life questionnaire (AQLQ) [ Time Frame: 4 months ]
    assessment of the successful step down of inhaled corticosteroid using asthma quality of life questionnaire (AQLQ)


Secondary Outcome Measures :
  1. assessment of asthma control by the asthma control questionnaire questionnaire [ Time Frame: 4 months ]
    by the asthma control questionnaire

  2. assessment of asthma quality of life by the asthma quality of life questionnaire [ Time Frame: 4 months ]
    by the asthma quality of life questionnaire

  3. assessment of rhinitis control by the rhinitis quality of life questionnaire [ Time Frame: 4 months ]
    by the rhinitis quality of life questionnaire


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773628


Locations
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Belgium
CHu Saint Pierre
Brussels, Belgium, 1000
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
More Information
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Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT02773628    
Other Study ID Numbers: AK/15-12-127/4581
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases