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Completed

NCT Number: NCT02502825

Comparison of Methacholine Bronchial Provocation With Wright and Devilbiss646 Nebulizers

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methacholine

Other

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

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

Primary outcomes

  1. percentage of the participants that tested positive to methacholine bronchial provocation with Wright or Devilbiss646 nebulizer

    Time frame: 5 minutes after each challenge

Secondary outcomes

  1. Incidence and severity of Adverse Events during the methacholine bronchial provocation tests with Wright nebulizer and Devilbiss646 nebulizer

    Time frame: during and until 5 minutes after each challenge

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Collaborators

  • Firestone Institute for Respiratory Health

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 20, 2015
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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