Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou

NCT ID: NCT02504528

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2018-02-01

Brief Summary

The purpose of this study is to establish the methodology of bronchial provocation tests with house dust mites in China, and to evaluate its safety and effects on upper and lower airways inflammation.

Detailed Description

After screening,each participant undergo baseline lung function test,airway inflammation evaluation (blood and sputum eosinophils count,interleukin-13 (IL-13),FeNO)and airway responsiveness tests(methacholine bronchial provocation,nasal histamine provocation).

On the second day,the participant undergo bronchial house dust mites challenge tests.

On the third day,the participant undergo the lung function test,airway inflammation evaluation (blood and sputum eosinophils count,IL-13,FeNO)and airway responsiveness tests(methacholine bronchial provocation,nasal histamine provocation).

Conditions

Allergic Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

allergic asthma

asthma patients that sensitive to house dust mites.

Group Type: EXPERIMENTAL

house dust mites

Intervention Type: OTHER

house dust mites(two-fold increasing concentration of house dust mite (HDM) extract, dilutions prepared starting from 1:8, 1:16, 1:32, 1:64, 1:128, 1: 256, 1:512, 1:1024,……)

normal controls

normal controls with or without sensitive to house dust mites.

Group Type: EXPERIMENTAL

house dust mites

Intervention Type: OTHER

house dust mites(two-fold increasing concentration of house dust mite (HDM) extract, dilutions prepared starting from 1:8, 1:16, 1:32, 1:64, 1:128, 1: 256, 1:512, 1:1024,……)

Interventions

house dust mites

house dust mites(two-fold increasing concentration of house dust mite (HDM) extract, dilutions prepared starting from 1:8, 1:16, 1:32, 1:64, 1:128, 1: 256, 1:512, 1:1024,……)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of asthma;
• Sensitive to house dust mite;
• Stable for more than 4 weeks with FEV1≥70%pred

Exclusion Criteria

• exacerbation within 3 months;
• upper airway infections within 6 weeks;
• concomitant of hypertension or heart diseases;
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Firestone Institute for Respiratory Health

OTHER

Sponsor Role: collaborator

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

Jinping Zheng

Deputy director,GRID

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinping Zheng

Role: PRINCIPAL_INVESTIGATOR

State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University

Locations

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

BAPT201534

Identifier Type: REGISTRY

Identifier Source: secondary_id

GIRD201534

Identifier Type: -

Identifier Source: org_study_id