Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou

Guangzhou Institute of Respiratory Disease

Status: Completed

Conditions: Allergic Asthma

Treatments: Other: house dust mites

Study type: Interventional

Funder types: Other

Identifiers

NCT02504528

BAPT201534 (Registry Identifier)

GIRD201534

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

allergic asthma

Experimental group

Description:

asthma patients that sensitive to house dust mites.

Treatment:

Other: house dust mites

normal controls

Experimental group

Description:

normal controls with or without sensitive to house dust mites.

Treatment:

Other: house dust mites