Comparison of Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02502825

Enrollment

Registered

2015-07-20

Start date

2015-07-31

Completion date

2016-12-31

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

OTHERmethacholine

methacholine (0.03,0.06,0.125,0.5,1.0,2.0,4.0,8.0,16.0 mg/ml),Canada

DEVICEWright Nebulizer

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

DEVICEDevilbiss646 Nebulizer

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026