Effect of high dose inhaled corticosteroid on airway remodeling in asthmatic patients with IL13, STAT4, GLCCI1, CHI3L1, and other SNPs homozygote

JRCT ID: jRCT1091220045

Registered date:31/08/2010

Basic Information

• Recruitment status: RECRUITING
• Health condition(s) or Problem(s) studied: Bronchial asthma
• Date of first enrollment: 01/02/2009
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention type:DRUG
Name of intervention:high-dose inhaled corticosteroid
Dose form / Japanese Medical Device Nomenclature:INHALANT
Route of administration / Site of application:INHALATIONAL
Dose per administration:400
800
microgram
Dosing frequency / Frequency of use:BID
everyday
Planned duration of intervention:260 weeks
Intended dose regimen:400 microgram bid
detailes of teratment arms:
Comparative intervention name:standard treatment
Dose form / Japanese Medical Device Nomenclature:INHALANT
Route of administration / Site of application:INHALATIONAL
Dose per administration:400-800
800-1600
microgram
Dosing frequency / Frequency of use:QD
everyday
Planned duration of intervention:260 weeks
Intended dose regimen:usual use

Outcome(s)

• Primary Outcome: pulmonary function
• Secondary Outcome: Subepithelia layer thickness and concentration of the mediators in bronchial lavage fluid

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Bronchial asthmatic patinets
• Exclude criteria: current smoker

Related Information

• Primary Sponsor: Yutaka Nakamura
• Secondary Sponsor: Iwate Medical University
• Source(s) of Monetary Support: Grant-in-Aid for Scientific Research from Japan Society for the Promotion of Science
• Secondary ID(s): JMA-IIA00045