Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou

Bronchial Provocation Tests With House Dust Mite in Allergic Asthma 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.

Study Overview

• Status: Completed
• Conditions: Allergic Asthma
• Intervention / Treatment: Other: house dust mites

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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangzhou Institute of Respiratory Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: allergic asthma; asthma patients that sensitive to house dust mites.	Other: 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,……)
Experimental: normal controls; normal controls with or without sensitive to house dust mites.	Other: 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,……)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentages of the participants that tested positive to house dust mites bronchial provocation	30 minutes after house dust mites bronchial provocation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of the percentages of eosinophils in sputum, nasal lavage and fractional exhaled nitric oxide (FeNO) from baseline		30mins, 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 provocation		24 hours after house dust mites bronchial challenge
percentages of the participants that tested positive to house dust mites bronchial provocation measured by impulse oscillometry		10 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 provocation	By Comparison with methacholine provocation test	24 hours after house dust mites bronchial challenge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlate of IL-4,IL-13,periostin with provocative concentration induced a 20% decrease in FEV1 to house dust mite in asthmatic	By Comparison with methacholine provocation test	30 mins and 24 hours after house dust mites bronchial challenge
Incidence and Severity of Adverse Events During The House Dust Mite Bronchial Provocation Test	By Comparison with methacholine provocation test at 30 min and 24 hours after challenge test.	30 minutes, 7 hours and 24 hours after house dust mites bronchial provocation

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Collaborators: Firestone Institute for Respiratory Health
• Investigators: Principal Investigator: Jinping Zheng, State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimate): July 22, 2015

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: asthma; allergy; bronchial hyperresponsiveness; provocation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: GIRD201534; BAPT201534 (Registry Identifier: BAPT201534)