Skip to main content
OpenTrials
Completed

NCT Number: NCT02504528

Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Asthma Asthma Bronchial Diseases Bronchial Hyperreactivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

house dust mites

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,……)

Primary outcomes

  1. percentages of the participants that tested positive to house dust mites bronchial provocation

    Time frame: 30 minutes after house dust mites bronchial provocation

Secondary outcomes

  1. Changes of the percentages of eosinophils in sputum, nasal lavage and fractional exhaled nitric oxide (FeNO) from baseline

    Time frame: 30mins, 7 and 24 hours after bronchial challenge

  2. 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 provocation

    Time frame: 24 hours after house dust mites bronchial challenge

  3. percentages of the participants that tested positive to house dust mites bronchial provocation measured by impulse oscillometry

    Time frame: 10 minutes after house dust mites bronchial provocation

  4. Changes of provocative concentration induced a 60% increase in nasal airway resistance to histamine before and after house dust mites bronchial provocation

    Time frame: 24 hours after house dust mites bronchial challenge

    By Comparison with methacholine provocation test

Other outcomes

  1. correlate of IL-4,IL-13,periostin with provocative concentration induced a 20% decrease in FEV1 to house dust mite in asthmatic

    Time frame: 30 mins and 24 hours after house dust mites bronchial challenge

    By Comparison with methacholine provocation test

  2. Incidence and Severity of Adverse Events During The House Dust Mite Bronchial Provocation Test

    Time frame: 30 minutes, 7 hours and 24 hours after house dust mites bronchial provocation

    By Comparison with methacholine provocation test at 30 min and 24 hours after challenge test.

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Collaborators

  • Firestone Institute for Respiratory Health

Registry information

Official study title

Bronchial Provocation Tests With House Dust Mite in Allergic Asthma in Guangzhou

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jul 22, 2015
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.