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

Primary Purpose

Asthma

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Acar'up system
Acar'up placebo system
Sponsored by
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

16 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHu Saint Pierre

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control group

treatment group

Arm Description

stable asthmatics receiving an Acar'up placebo system

stable asthmatics receiving Acar'up system

Outcomes

Primary Outcome Measures

assessment of successful stepdown of inhaled corticosteroid using clinical evaluation
assessment of the successful step down of inhaled corticosteroid using clinical evaluation
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)
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)

Secondary Outcome Measures

assessment of asthma control by the asthma control questionnaire questionnaire
by the asthma control questionnaire
assessment of asthma quality of life by the asthma quality of life questionnaire
by the asthma quality of life questionnaire
assessment of rhinitis control by the rhinitis quality of life questionnaire
by the rhinitis quality of life questionnaire

Full Information

First Posted
April 25, 2016
Last Updated
February 7, 2019
Sponsor
Centre Hospitalier Universitaire Saint Pierre
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1. Study Identification

Unique Protocol Identification Number
NCT02773628
Brief Title
Impact of Reduction of Dust Mite Allergenic Load on Step Down of Inhaled Corticosteroids in Stable Asthma
Official Title
Impact of Reduction of Dust Mite Allergenic Load on Step Down of Inhaled Corticosteroids in Stable Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
methodological concerns about study design
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
stable asthmatics receiving an Acar'up placebo system
Arm Title
treatment group
Arm Type
Active Comparator
Arm Description
stable asthmatics receiving Acar'up system
Intervention Type
Device
Intervention Name(s)
Acar'up system
Intervention Type
Device
Intervention Name(s)
Acar'up placebo system
Primary Outcome Measure Information:
Title
assessment of successful stepdown of inhaled corticosteroid using clinical evaluation
Description
assessment of the successful step down of inhaled corticosteroid using clinical evaluation
Time Frame
4 months
Title
assessment of successful stepdown of inhaled corticosteroid using asthma scale: asthma control questionnaire (ACQ)
Description
assessment of the successful step down of inhaled corticosteroid using asthma scale: asthma control questionnaire (ACQ)
Time Frame
4 months
Title
assessment of successful stepdown of inhaled corticosteroid using asthma quality of life questionnaire (AQLQ)
Description
assessment of the successful step down of inhaled corticosteroid using asthma quality of life questionnaire (AQLQ)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
assessment of asthma control by the asthma control questionnaire questionnaire
Description
by the asthma control questionnaire
Time Frame
4 months
Title
assessment of asthma quality of life by the asthma quality of life questionnaire
Description
by the asthma quality of life questionnaire
Time Frame
4 months
Title
assessment of rhinitis control by the rhinitis quality of life questionnaire
Description
by the rhinitis quality of life questionnaire
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHu Saint Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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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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