Comparison of Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers

NCT ID: NCT02502825

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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After screening,each asthmatic patient will visit the investigators' center 4 times.

During the first week, the patient will be randomised to undergo methacholine bronchial challenge with Wright or Devilbiss 646 nebulizer on two separate days, which are at least 24 hours but not more than 7 days apart.The above procedure will be repeated for each patient in one month. But the nebulizer will be selected in a reverse order.Provocative concentration induced a 20% decrease in forced expiratory volume in one second (PC20) will be calculated for each test. Record all the adverse events during the tests.

Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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asthma

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.

Group Type EXPERIMENTAL

methacholine

Intervention Type OTHER

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

Wright Nebulizer

Intervention Type DEVICE

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

Devilbiss646 Nebulizer

Intervention Type DEVICE

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

normal controls

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

Group Type EXPERIMENTAL

methacholine

Intervention Type OTHER

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

Wright Nebulizer

Intervention Type DEVICE

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

Devilbiss646 Nebulizer

Intervention Type DEVICE

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

Interventions

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methacholine

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

Intervention Type OTHER

Wright Nebulizer

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

Intervention Type DEVICE

Devilbiss646 Nebulizer

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* exacerbation within 3 months;
* upper airway infections within 4 weeks;
* concomitant of hypertension or heart diseases;
* pregnancy;
* under immunotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Firestone Institute for Respiratory Health

OTHER

Sponsor Role collaborator

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role lead

Responsible Party

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Jinping Zheng

deputy director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinping Zheng

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Guangzhou institute of respiratory disease

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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GIRD201533

Identifier Type: -

Identifier Source: org_study_id

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