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

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 |
- 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
- 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)
- 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)
- assessment of asthma control by the asthma control questionnaire questionnaire [ Time Frame: 4 months ]by the asthma control questionnaire
- assessment of asthma quality of life by the asthma quality of life questionnaire [ Time Frame: 4 months ]by the asthma quality of life questionnaire
- assessment of rhinitis control by the rhinitis quality of life questionnaire [ Time Frame: 4 months ]by the rhinitis quality of life questionnaire

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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 |
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

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
Belgium | |
CHu Saint Pierre | |
Brussels, Belgium, 1000 |
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 |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |