Comparison of Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: methacholine; Device: Wright Nebulizer; Device: Devilbiss646 Nebulizer

• Registration Number: NCT02502825
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-20
• Primary Completion: 2016-07
• Study Completion: 2016-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
asthma	methacholine	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	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
normal controls	Wright 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
asthma	Wright Nebulizer	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.
asthma	Devilbiss646 Nebulizer	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	methacholine	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

Primary Outcome Measures

Name	Time	Method
percentage of the participants that tested positive to methacholine bronchial provocation with Wright or Devilbiss646 nebulizer	5 minutes after each challenge

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Guangzhou institute of respiratory disease; 🇨🇳 Guangzhou, Guangdong, China