Comparison of Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers

February 14, 2018 updated by: Jinping Zheng, Guangzhou Institute of Respiratory Disease

Comparison of 2-min Tidal Breathing Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangzhou Institute of Respiratory Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: methacholine
methacholine (0.03,0.06,0.125,0.5,1.0,2.0,4.0,8.0,16.0 mg/ml),Canada
Device: Wright Nebulizer
nebulized for 2 minutes with an output of 0.13ml/min
Device: Devilbiss646 Nebulizer
nebulized for 2 minutes with an output of 0.13ml/min
Experimental: 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
Other: methacholine
methacholine (0.03,0.06,0.125,0.5,1.0,2.0,4.0,8.0,16.0 mg/ml),Canada
Device: Wright Nebulizer
nebulized for 2 minutes with an output of 0.13ml/min
Device: Devilbiss646 Nebulizer
nebulized for 2 minutes with an output of 0.13ml/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of the participants that tested positive to methacholine bronchial provocation with Wright or Devilbiss646 nebulizer
Time Frame: 5 minutes after each challenge
5 minutes after each challenge

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of Adverse Events during the methacholine bronchial provocation tests with Wright nebulizer and Devilbiss646 nebulizer
Time Frame: during and until 5 minutes after each challenge
during and until 5 minutes after each challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Institute of Respiratory Disease

Collaborators

Firestone Institute for Respiratory Health

Investigators

  • Principal Investigator: Jinping Zheng, State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

July 17, 2015

First Posted (Estimate)

July 20, 2015

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIRD201533

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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