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Trial record 20 of 248 for:    test AND provocation

Comparison of Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers

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ClinicalTrials.gov Identifier: NCT02502825
Recruitment Status : Completed
First Posted : July 20, 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

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.

Condition or disease Intervention/treatment Phase
Asthma Other: methacholine Device: Wright Nebulizer Device: Devilbiss646 Nebulizer Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of 2-min Tidal Breathing Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers
Actual Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




Primary Outcome Measures :
  1. percentage of the participants that tested positive to methacholine bronchial provocation with Wright or Devilbiss646 nebulizer [ Time Frame: 5 minutes after each challenge ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502825


Locations
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China, Guangdong
Guangzhou institute of respiratory disease
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Firestone Institute for Respiratory Health
Investigators
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Principal Investigator: Jinping Zheng State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University

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Responsible Party: Jinping Zheng, deputy director, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT02502825     History of Changes
Other Study ID Numbers: GIRD201533
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Methacholine Chloride
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action