MedPath

Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou

Not Applicable
Completed
Conditions
Allergic Asthma
Interventions
Other: house dust mites
Registration Number
NCT02504528
Lead Sponsor
Guangzhou Institute of Respiratory Disease
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
allergic asthmahouse dust mitesasthma patients that sensitive to house dust mites.
normal controlshouse dust mitesnormal controls with or without sensitive to house dust mites.
Primary Outcome Measures
NameTimeMethod
percentages of the participants that tested positive to house dust mites bronchial provocation30 minutes after house dust mites bronchial provocation
Secondary Outcome Measures
NameTimeMethod
percentages of the participants that tested positive to house dust mites bronchial provocation measured by impulse oscillometry10 minutes after house dust mites bronchial provocation
Changes of provocative concentration induced a 60% increase in nasal airway resistance to histamine before and after house dust mites bronchial provocation24 hours after house dust mites bronchial challenge

By Comparison with methacholine provocation test

Changes of the percentages of eosinophils in sputum, nasal lavage and fractional exhaled nitric oxide (FeNO) from baseline30mins, 7 and 24 hours after bronchial challenge
Changes of provocative concentration induced a 20% decrease in forced expiratory volume at one second (FEV1) to methacholine before and after house dust mites bronchial provocation24 hours after house dust mites bronchial challenge

Trial Locations

Locations (1)

Guangzhou institute of respiratory disease

🇨🇳

Guangzhou, Guangdong, China

© Copyright 2025. All Rights Reserved by MedPath