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| Name | Class |
|---|---|
| Firestone Institute for Respiratory Health | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methacholine | Other | methacholine (0.03,0.06,0.125,0.5,1.0,2.0,4.0,8.0,16.0 mg/ml),Canada |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of the participants that tested positive to methacholine bronchial provocation with Wright or Devilbiss646 nebulizer | 5 minutes after each challenge |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinping Zheng | State Key Laboratory of Respiratory Disease; China Clinical Research Center of Respiratory Disease; First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou institute of respiratory disease | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D016210 | Methacholine Chloride |
| ID | Term |
|---|---|
| D008688 | Methacholine Compounds |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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| Wright Nebulizer | Device | nebulized for 2 minutes with an output of 0.13ml/min |
|
| Devilbiss646 Nebulizer | Device | nebulized for 2 minutes with an output of 0.13ml/min |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |