Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou

Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504528
• Other study ID #: GIRD201534
• Secondary ID: BAPT201534
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: February 14, 2018
• Start date: July 1, 2015
• Est. completion date: February 1, 2018

Study information

• Verified date: February 2018
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2018
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

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,……)

Locations

Country	Name	City	State
China	Guangzhou institute of respiratory disease	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease	Firestone Institute for Respiratory Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	percentages of the participants that tested positive to house dust mites bronchial provocation		30 minutes after house dust mites bronchial provocation
Secondary	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
Secondary	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
Secondary	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
Secondary	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