NCT02502825

Brief Summary

The purpose of this study is to compare the diagnostic validity (sensitivity and specificity) and evaluate the safety of 2-min Tidal Breathing methacholine bronchial provocation tests with the Wright and Devilbiss646 nebulizers in asthmatic in Guangzhou.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Jul 2015

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

Click on a node to explore related trials.

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
12 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

July 8, 2015

Last Update Submit

February 14, 2018

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • percentage of the participants that tested positive to methacholine bronchial provocation with Wright or Devilbiss646 nebulizer

    5 minutes after each challenge

Secondary Outcomes (1)

  • Incidence and severity of Adverse Events during the methacholine bronchial provocation tests with Wright nebulizer and Devilbiss646 nebulizer

    during and until 5 minutes after each challenge

Study Arms (2)

asthma

EXPERIMENTAL

methacholine(0.031-16mg/ml) bronchial provocation tests. this is a crossover,normal-control study. nebulized with Wright nebulizer for 2 minutes with an output of 0.13ml/min.

Other: methacholineDevice: Wright NebulizerDevice: Devilbiss646 Nebulizer

normal controls

EXPERIMENTAL

methacholine(0.031-16mg/ml) bronchial provocation tests. this is a crossover,normal-control study. nebulized with Devilbiss646 nebulizer for 2 minutes with an output of 0.13ml/min

Other: methacholineDevice: Wright NebulizerDevice: Devilbiss646 Nebulizer

Interventions

methacholineOTHER

methacholine (0.03,0.06,0.125,0.5,1.0,2.0,4.0,8.0,16.0 mg/ml),Canada

asthmanormal controls
Wright NebulizerDEVICE

nebulized for 2 minutes with an output of 0.13ml/min

asthmanormal controls
Devilbiss646 NebulizerDEVICE

nebulized for 2 minutes with an output of 0.13ml/min

asthmanormal controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of asthma;
  • stable for more than 4 weeks with FEV1≥65%pred

You may not qualify if:

  • exacerbation within 3 months;
  • upper airway infections within 4 weeks;
  • concomitant of hypertension or heart diseases;
  • pregnancy;
  • under immunotherapy

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

Asthma

Interventions

Methacholine Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methacholine CompoundsTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

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

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 20, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

CN(1)