NCT03307278

Brief 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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Status
withdrawn

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

September 26, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2018

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

September 26, 2017

Last Update Submit

July 27, 2021

Conditions

Allergic Asthma

Outcome Measures

Primary Outcomes (2)

  • inflammasome activation by HDM

    The expression of NLRP3 in PBMCs will be measured by western blot after HDM stimulation.

    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.

    6 hours

Study Arms (2)

Steroid resistance in HDM allergic patients

EXPERIMENTAL
Biological: House dust mite

Steroid resistance in non HDM allergic subjects

EXPERIMENTAL
Biological: House dust mite

Interventions

House dust miteBIOLOGICAL

As a stimulant to induce inflammasome activation

Steroid resistance in HDM allergic patientsSteroid resistance in non HDM allergic subjects

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HDM allergic and non allergic subjects

You may not qualify if:

  • Pregnant subject, cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Antigens, Dermatophagoides

Intervention Hierarchy (Ancestors)

AntigensBiological Factors
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 11, 2017

Study Start

November 30, 2017

Primary Completion

September 6, 2018

Study Completion

September 6, 2018

Last Updated

August 2, 2021

Record last verified: 2021-07