NCT02773628

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started May 2016

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

2.3 years

First QC Date

April 25, 2016

Last Update Submit

February 7, 2019

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

  • assessment of successful stepdown of inhaled corticosteroid using clinical evaluation

    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)

    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)

    assessment of the successful step down of inhaled corticosteroid using asthma quality of life questionnaire (AQLQ)

    4 months

Secondary Outcomes (3)

  • assessment of asthma control by the asthma control questionnaire questionnaire

    4 months

  • assessment of asthma quality of life by the asthma quality of life questionnaire

    4 months

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

    4 months

Study Arms (2)

control group

PLACEBO COMPARATOR

stable asthmatics receiving an Acar'up placebo system

Device: Acar'up placebo system

treatment group

ACTIVE COMPARATOR

stable asthmatics receiving Acar'up system

Device: Acar'up system

Interventions

Acar'up systemDEVICE
treatment group
Acar'up placebo systemDEVICE
control group

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHu Saint Pierre

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 16, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)