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

February 7, 2019 updated by: Centre Hospitalier Universitaire Saint Pierre
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • CHU Saint Pierre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months
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)
4 months
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)
4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (Estimate)

May 16, 2016

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK/15-12-127/4581

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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