NCT02504528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

July 8, 2015

Last Update Submit

February 14, 2018

Conditions

Allergic Asthma

Keywords

asthmaallergybronchial hyperresponsivenessprovocation

Outcome Measures

Primary Outcomes (1)

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

    30 minutes after house dust mites bronchial provocation

Secondary Outcomes (4)

  • 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

  • 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

  • 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

  • Changes of provocative concentration induced a 60% increase in nasal airway resistance to histamine before and after house dust mites bronchial provocation

    24 hours after house dust mites bronchial challenge

Other Outcomes (2)

  • correlate of IL-4,IL-13,periostin with provocative concentration induced a 20% decrease in FEV1 to house dust mite in asthmatic

    30 mins and 24 hours after house dust mites bronchial challenge

  • Incidence and Severity of Adverse Events During The House Dust Mite Bronchial Provocation Test

    30 minutes, 7 hours and 24 hours after house dust mites bronchial provocation

Study Arms (2)

allergic asthma

EXPERIMENTAL

asthma patients that sensitive to house dust mites.

Other: house dust mites

normal controls

EXPERIMENTAL

normal controls with or without sensitive to house dust mites.

Other: house dust mites

Interventions

house dust mitesOTHER

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,……)

allergic asthmanormal controls

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of asthma;
  • Sensitive to house dust mite;
  • Stable for more than 4 weeks with FEV1≥70%pred

You may not qualify if:

  • exacerbation within 3 months;
  • upper airway infections within 6 weeks;
  • concomitant of hypertension or heart diseases;
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

AsthmaHypersensitivityBronchial Hyperreactivity

Interventions

Antigens, Dermatophagoides

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateImmune System Diseases

Intervention Hierarchy (Ancestors)

AntigensBiological Factors

Study Officials

  • Jinping Zheng

    State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director,GRID

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 22, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2017

Study Completion

February 1, 2018

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

CN(1)