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Trial record 7 of 257 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

Tracking Information
First Submitted Date  ICMJE July 8, 2015
First Posted Date  ICMJE July 22, 2015
Last Update Posted Date February 16, 2018
Study Start Date  ICMJE July 1, 2015
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
percentages of the participants that tested positive to house dust mites bronchial provocation [ Time Frame: 30 minutes after house dust mites bronchial provocation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02504528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2015)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 20, 2015)
  • 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
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou
Official Title  ICMJE Bronchial Provocation Tests With House Dust Mite in Allergic Asthma in Guangzhou
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Allergic Asthma
Intervention  ICMJE 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,……)
Study Arms  ICMJE
  • Experimental: allergic asthma
    asthma patients that sensitive to house dust mites.
    Intervention: Other: house dust mites
  • Experimental: normal controls
    normal controls with or without sensitive to house dust mites.
    Intervention: Other: house dust mites
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2015)
60
Actual Study Completion Date  ICMJE February 1, 2018
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02504528
Other Study ID Numbers  ICMJE GIRD201534
BAPT201534 ( Registry Identifier: BAPT201534 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jinping Zheng, Guangzhou Institute of Respiratory Disease
Study Sponsor  ICMJE Guangzhou Institute of Respiratory Disease
Collaborators  ICMJE Firestone Institute for Respiratory Health
Investigators  ICMJE
Principal Investigator: Jinping Zheng State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University
PRS Account Guangzhou Institute of Respiratory Disease
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP