AsthmaNCT02773628
Impact of Reduction of Dust Mite Allergenic Load on Step Down of Inhaled Corticosteroids in Stable Asthma
A study testing Acar'up system in people with Asthma, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Asthma
- What is being tested?
- Acar'up system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteBelgium
- Study dates
- May 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Acar'up system, Acar'up placebo system
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acar'up systemDevice
Acar'up placebo systemDevice
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | stable asthmatics receiving an Acar'up placebo system Receives: Device: Acar'up placebo system |
| treatment group | Active comparator | stable asthmatics receiving Acar'up system Receives: Device: Acar'up system |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of successful stepdown of inhaled corticosteroid using clinical evaluation
assessment of the successful step down of inhaled corticosteroid using clinical evaluation
Measured: 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)
Measured: 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)
Measured: 4 months
Secondary outcomes (3)
assessment of asthma control by the asthma control questionnaire questionnaire
by the asthma control questionnaire
Measured: 4 months
assessment of asthma quality of life by the asthma quality of life questionnaire
by the asthma quality of life questionnaire
Measured: 4 months
assessment of rhinitis control by the rhinitis quality of life questionnaire
by the rhinitis quality of life questionnaire
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2018
- Study completionAug 2018
Why it stopped: methodological concerns about study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773628
- Sponsor's protocol ID
- AK/15-12-127/4581
- Status last verified
- Feb 2019
- First submitted
- 25 Apr 2016
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reduction of Dust Mite Allergenic Load on Step Down of Inhaled Corticosteroids in Stable Asthma
- ClinicalTrials.gov ID
- NCT02773628
- Acronym / sponsor ID
- AK/15-12-127/4581
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: methodological concerns about study design
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Device: Acar'up placebo systemstable asthmatics receiving an Acar'up placebo system |
| treatment group | Active comparator | Device: Acar'up systemstable asthmatics receiving Acar'up system |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acar'up system | Device | treatment group |
| Acar'up placebo system | Device | control group |
Primary outcome
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)
3 secondary outcomes
assessment of asthma control by the asthma control questionnaire questionnaire
Time frame: 4 months
assessment of asthma quality of life by the asthma quality of life questionnaire
Time frame: 4 months
assessment of rhinitis control by the rhinitis quality of life questionnaire
Time frame: 4 months
Results and safety
The study was stopped early (reason given: methodological concerns about study design). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acar'up system in people with Asthma, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: methodological concerns about study design). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of successful stepdown of inhaled corticosteroid using clinical evaluation (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.