An interventional study of methacholine and Wright Nebulizer in Asthma, sponsored by Guangzhou Institute of Respiratory Disease. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by Guangzhou Institute of Respiratory Disease · Not applicable, Interventional, and Diagnostic
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.
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.
Guangzhou Institute of Respiratory Disease is the lead sponsor of 96 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Device: Wright Nebulizer · Device: Devilbiss646 Nebulizer
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 · Device: Wright Nebulizer · Device: Devilbiss646 Nebulizer
methacholine (0.03,0.06,0.125,0.5,1.0,2.0,4.0,8.0,16.0 mg/ml),Canada
nebulized for 2 minutes with an output of 0.13ml/min
nebulized for 2 minutes with an output of 0.13ml/min
percentage of the participants that tested positive to methacholine bronchial provocation with Wright or Devilbiss646 nebulizer
Time frame: 5 minutes after each challenge
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
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Guangzhou Institute of Respiratory Disease