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Trial record 7 of 251 for:    test AND provocation

Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou

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ClinicalTrials.gov Identifier: NCT02504528
Recruitment Status : Completed
First Posted : July 22, 2015
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
Firestone Institute for Respiratory Health
Information provided by (Responsible Party):
Jinping Zheng, Guangzhou Institute of Respiratory Disease

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.

Condition or disease Intervention/treatment Phase
Allergic Asthma Other: house dust mites Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Bronchial Provocation Tests With House Dust Mite in Allergic Asthma in Guangzhou
Study Start Date : July 1, 2015
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Odactra

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,……)




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504528


Locations
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China, Guangdong
Guangzhou institute of respiratory disease
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Firestone Institute for Respiratory Health
Investigators
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Principal Investigator: Jinping Zheng State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University

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Responsible Party: Jinping Zheng, Deputy director,GRID, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT02504528     History of Changes
Other Study ID Numbers: GIRD201534
BAPT201534 ( Registry Identifier: BAPT201534 )
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Keywords provided by Jinping Zheng, Guangzhou Institute of Respiratory Disease:
asthma
allergy
bronchial hyperresponsiveness
provocation
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases