Comparison of Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers

Guangzhou Institute of Respiratory Disease

Status: Completed

Conditions: Asthma

Treatments: Device: Wright Nebulizer; Other: methacholine; Device: Devilbiss646 Nebulizer

Study type: Interventional

Funder types: Other

Identifiers

NCT02502825

GIRD201533

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

asthma

Experimental group

Description:

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.

Treatment:

Device: Devilbiss646 Nebulizer

Device: Wright Nebulizer

Other: methacholine

normal controls

Experimental group

Description:

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

Treatment:

Device: Devilbiss646 Nebulizer

Device: Wright Nebulizer

Other: methacholine