Comprehensive analysis of genetic predisposition in refractory asthma

JRCT ID: jRCT1090220341

Registered date:05/04/2018

Basic Information

• Recruitment status: RECRUITING
• Health condition(s) or Problem(s) studied: Refractory asthma
• Date of first enrollment: 16/11/2017
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention type:PROCEDURE
Name of intervention:Biopsy and Blood sampling
Dose form / Japanese Medical Device Nomenclature:DEVICE
Bronchial thermoplasty
Route of administration / Site of application:
Dose per administration:
Dosing frequency / Frequency of use:OTHER, SPECIFY
Three times more than three weeks apart
Planned duration of intervention:Within one hour
Intended dose regimen:While bronchial thermoplasty is performed, while collecting blood before and after bronchial thermoplasty, we perform biopsies of three airway tissues per bronchial thermoplasty at the bronchial branching point.
detailes of teratment arms:Airway tissues of refractory asthma patients immediately before and immediately after bronchial thermoplasty are collected, a part is used for gene analysis, and others are immunostained for pathological consideration. Blood is collected before and after the bronchial thermoplasty, and gene analysis is performed by isolating mononuclear cells from the peripheral blood.
Comparative intervention name:
Dose form / Japanese Medical Device Nomenclature:
Route of administration / Site of application:
Dose per administration:
Dosing frequency / Frequency of use:
Planned duration of intervention:
Intended dose regimen:

Outcome(s)

• Primary Outcome: Variable genes in the airway tissues or mononuclear cells in the peripheral blood of severe asthma patients
• Secondary Outcome: Pathological images of airway tissues before and after bronchial thermoplasty

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients who are diagnosed with bronchial asthma and require high-dose inhaled corticosteroids and long-acting beta2 stimulants for asthma control.
2.Other patients applicable to the proper usage criteria of bronchial thermoplasty system.

Exclude criteria

1.Patients who are later found out to have a disease other than bronchial asthma.
2.Patients who other researchers judged inappropriate.

Related Information

• Source(s) of Monetary Support: Own resources
• Secondary ID(s): Nill Known,JMA-IIA00341