Allergic AsthmaNCT03307278
House Dust Mite Induced Inflammasome Activation on Corticosteroid Resistance
A study testing House dust mite in people with Allergic Asthma, run by China Medical University Hospital.
Trial summary
In this project, PBMCs will be isolated from HDM allergic and non allergic patient and then stimulated with HDM crude extract. The expression of inflammasome and the correlation of inflammasome activation and steroid resistance will be investigated. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- House dust mite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2017to 6 Sep 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HDM allergic and non allergic subjects
Who cannot join
- Pregnant subject, cancer
About this study
Official title: Effects and Mechanism of House Dust Mite Induced Inflammasome Activation on Corticosteroid Resistance
In this project, PBMCs will be isolated from HDM allergic and non allergic patient and then stimulated with HDM crude extract. The expression of inflammasome and the correlation of inflammasome activation and steroid resistance will be investigated.
- Conditions
- Allergic Asthma
- Being tested
- House dust mite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
House dust miteBiological
As a stimulant to induce inflammasome activation
| Study group | Role | What they receive |
|---|---|---|
| Steroid resistance in HDM allergic patients | Experimental | Not described Receives: Biological: House dust mite |
| Steroid resistance in non HDM allergic subjects | Experimental | Not described Receives: Biological: House dust mite |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammasome activation by HDM
The expression of NLRP3 in PBMCs will be measured by western blot after HDM stimulation.
Measured: 6 hours
Steroid receptor phosphorylation by HDM
The expression of steroid receptor will be detected by western blot and real-time PCR after HDM stimulation.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start30 Nov 2017 (estimated)
- Primary completion6 Sep 2018 (estimated)
- Study completion6 Sep 2018 (estimated)
Why it stopped: The research project cannot be implemented because the project has not received funding subsidies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307278
- Sponsor's protocol ID
- CMUH106-REC3-115
- Status last verified
- Jul 2021
- First submitted
- 26 Sep 2017
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanism of House Dust Mite Induced Inflammasome Activation on Corticosteroid Resistance
- ClinicalTrials.gov ID
- NCT03307278
- Acronym / sponsor ID
- CMUH106-REC3-115
- Conditions
- Allergic Asthma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The research project cannot be implemented because the project has not received funding subsidies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 30 Nov 2017 (estimated)
- Primary completion
- 6 Sep 2018 (estimated)
- Study completion
- 6 Sep 2018 (estimated)
- First posted
- 11 Oct 2017 (actual)
- 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.
In this project, PBMCs will be isolated from HDM allergic and non allergic patient and then stimulated with HDM crude extract. The expression of inflammasome and the correlation of inflammasome activation and steroid resistance will be investigated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid resistance in HDM allergic patients | Experimental | Biological: House dust mite |
| Steroid resistance in non HDM allergic subjects | Experimental | Biological: House dust mite |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HDM allergic and non allergic subjects
Key exclusion criteria (1 listed)
- Pregnant subject, cancer
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 |
|---|---|---|
| House dust miteAs a stimulant to induce inflammasome activation | Biological | Steroid resistance in HDM allergic patients, Steroid resistance in non HDM allergic subjects |
Primary outcome
inflammasome activation by HDM
Time frame: 6 hours
The expression of NLRP3 in PBMCs will be measured by western blot after HDM stimulation.
Steroid receptor phosphorylation by HDM
Time frame: 6 hours
The expression of steroid receptor will be detected by western blot and real-time PCR after HDM stimulation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing House dust mite in people with Allergic Asthma, run by China Medical University Hospital.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 withdrawn before enrolling participants, so there are no results.
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?
inflammasome activation by HDM (time frame: 6 hours). The study lists 2 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 2 Aug 2021.