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Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou

Primary Purpose

Allergic Asthma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
house dust mites
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Allergic Asthma focused on measuring asthma, allergy, bronchial hyperresponsiveness, provocation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Guangzhou institute of respiratory disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

allergic asthma

normal controls

Arm Description

asthma patients that sensitive to house dust mites.

normal controls with or without sensitive to house dust mites.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes of the percentages of eosinophils in sputum, nasal lavage and fractional exhaled nitric oxide (FeNO) from baseline
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
percentages of the participants that tested positive to house dust mites bronchial provocation measured by impulse oscillometry
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

Full Information

First Posted
July 8, 2015
Last Updated
February 14, 2018
Sponsor
Guangzhou Institute of Respiratory Disease
Collaborators
Firestone Institute for Respiratory Health
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1. Study Identification

Unique Protocol Identification Number
NCT02504528
Brief Title
Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou
Official Title
Bronchial Provocation Tests With House Dust Mite in Allergic Asthma in Guangzhou
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (undefined)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease
Collaborators
Firestone Institute for Respiratory Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma
Keywords
asthma, allergy, bronchial hyperresponsiveness, provocation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
allergic asthma
Arm Type
Experimental
Arm Description
asthma patients that sensitive to house dust mites.
Arm Title
normal controls
Arm Type
Experimental
Arm Description
normal controls with or without sensitive to house dust mites.
Intervention Type
Other
Intervention Name(s)
house dust mites
Intervention Description
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 Outcome Measure Information:
Title
percentages of the participants that tested positive to house dust mites bronchial provocation
Time Frame
30 minutes after house dust mites bronchial provocation
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Changes of provocative concentration induced a 60% increase in nasal airway resistance to histamine before and after house dust mites bronchial provocation
Description
By Comparison with methacholine provocation test
Time Frame
24 hours after house dust mites bronchial challenge
Other Pre-specified Outcome Measures:
Title
correlate of IL-4,IL-13,periostin with provocative concentration induced a 20% decrease in FEV1 to house dust mite in asthmatic
Description
By Comparison with methacholine provocation test
Time Frame
30 mins and 24 hours after house dust mites bronchial challenge
Title
Incidence and Severity of Adverse Events During The House Dust Mite Bronchial Provocation Test
Description
By Comparison with methacholine provocation test at 30 min and 24 hours after challenge test.
Time Frame
30 minutes, 7 hours and 24 hours after house dust mites bronchial provocation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinping Zheng
Organizational Affiliation
State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou institute of respiratory disease
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China

12. IPD Sharing Statement

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Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou

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