Clinical trial NCT02504528: 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
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Asthma
Keywords: asthma
allergy
bronchial hyperresponsiveness
provocation
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: Firestone Institute for Respiratory Health
First posted: 2015-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: percentages of the participants that tested positive to house dust mites bronchial provocation
timeFrame: 30 minutes after house dust mites bronchial provocation
Secondary outcomes:
measure: Changes of the percentages of eosinophils in sputum, nasal lavage and fractional exhaled nitric oxide (FeNO) from baseline
timeFrame: 30mins, 7 and 24 hours after bronchial challenge
measure: 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
timeFrame: 24 hours after house dust mites bronchial challenge
measure: percentages of the participants that tested positive to house dust mites bronchial provocation measured by impulse oscillometry
timeFrame: 10 minutes after house dust mites bronchial provocation
measure: Changes of provocative concentration induced a 60% increase in nasal airway resistance to histamine before and after house dust mites bronchial provocation
timeFrame: 24 hours after house dust mites bronchial challenge
Other outcomes:
measure: correlate of IL-4,IL-13,periostin with provocative concentration induced a 20% decrease in FEV1 to house dust mite in asthmatic
timeFrame: 30 mins and 24 hours after house dust mites bronchial challenge
measure: Incidence and Severity of Adverse Events During The House Dust Mite Bronchial Provocation Test
timeFrame: 30 minutes, 7 hours and 24 hours after house dust mites bronchial provocation
Locations:
city: Guangzhou
country: China
facility: Guangzhou institute of respiratory disease
state: Guangdong
Study officials:
affiliation: State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University
name: Jinping Zheng
role: PRINCIPAL_INVESTIGATOR
References: