Comparison of Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers

Asthma Clinical Trial

Official title:

Comparison of 2-min Tidal Breathing Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502825
• Other study ID #: GIRD201533
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: February 14, 2018
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2018
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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
• Devilbiss646 Nebulizer
nebulized for 2 minutes with an output of 0.13ml/min

Locations

Country	Name	City	State
China	Guangzhou institute of respiratory disease	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease	Firestone Institute for Respiratory Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of the participants that tested positive to methacholine bronchial provocation with Wright or Devilbiss646 nebulizer		5 minutes after each challenge
Secondary	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