A Comparative Bronchial Provocation Study With Mannitol and Methacolinie in a Korean Population
1 other identifier
interventional
104
0 countries
N/A
Brief Summary
Asthmatic patients and non-asthmatic controls were recruited prospectively from four referral hospitals in Korea. Participants were challenged with each of methacholine and mannitol inhalation on different days. Their diagnostic utility was evaluated by calculating their sensitivity and specificity for asthma diagnosis. Response-dose-ratio was also compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Jul 2011
Typical duration for not_applicable asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 21, 2014
CompletedFirst Posted
Study publicly available on registry
April 4, 2014
CompletedApril 4, 2014
April 1, 2014
2.4 years
March 21, 2014
April 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sensitivity comparison of the mannitol challenge test and methacholine challenge test
The diagnostic properties of the mannitol challenge test and methacholine challenge test (sensitivity, specificity, positive predictive value, and negative predictive value) were calculated against the physician's diagnosis of asthma. methacholine challenge test: positive at PC20 \< 16 mg/mL mannitoln test: positive if FEV1 fell by more than 15% until the last dose (until a cumulative dose of 635 mg) gold standard: physician's diagnosis of asthma sensitivity: true positive / true positive+false negative
60 minutes
Secondary Outcomes (3)
specificity comparison of the mannitol challenge test and methacholine challenge test
60 minutes
positive predictive value comparison of the mannitol challenge test and methacholine challenge test
60 minutes
negative predictive value comparison of the mannitol challenge test and methacholine challenge test
60 minutes
Study Arms (4)
Normal controls, methacholine positive
OTHERmethacholine and mannitol bronchial challenge tests: Positive methacholine challenge tests in normal controls
Normal controls, mannitol
OTHERmethacholine and mannitol bronchial challenge tests: Positive mannitol challenge tests in normal controls.
Asthma, Methacholine
ACTIVE COMPARATORmethacholine and mannitol bronchial challenge tests: Positive methacholine challenge tests in asthmatics
Asthma, Mannitol
ACTIVE COMPARATORmethacholine and mannitol bronchial challenge tests: Positive mannitol challenge tests in asthmatics
Interventions
Airway hyperresponsiveness is a common feature of asthma. Methacholine and mannitol are two representative agonists for bronchial challenge. They have theoretically different mechanisms of action, and may have different diagnostic properties. However, their difference has not been directly evaluated among Korean adults. In this study, we compare the diagnostic properties of methacholine and mannitol bronchial provocation tests. Asthmatic patients and non-asthmatic controls were recruited prospectively from four referral hospitals in Korea. Participants were challenged with each of methacholine and mannitol inhalation on different days. Their diagnostic utility was evaluated by calculating their sensitivity, specificity, positive/negative predictive values for asthma diagnosis.
Eligibility Criteria
You may not qualify if:
- History of recent respiratory infection (within the last 4 weeks)
- History of a recent surgery
- History of heart disease that could impose risks during bronchial challenges
- History of uncontrolled hypertension
- Current smokers or ex-smokers with more than 10 pack-years
- History of known pulmonary diseases with the exception of asthma
- Pregnancy or lactation
- Severe obesity (body mass index \[BMI\] of \>35 kg/m2)
- History of any health condition considered inappropriate for participation in this study
- Pre-bronchodilator predictive value of forced expiratory volume in 1 second (FEV1) of \<70%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BL&H Co., Ltdlead
Related Publications (1)
Kim MH, Song WJ, Kim TW, Jin HJ, Sin YS, Ye YM, Kim SH, Park HW, Lee BJ, Park HS, Yoon HJ, Choi DC, Min KU, Cho SH. Diagnostic properties of the methacholine and mannitol bronchial challenge tests: a comparison study. Respirology. 2014 Aug;19(6):852-6. doi: 10.1111/resp.12334. Epub 2014 Jun 26.
PMID: 24975800DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang-Heon Cho, M.D.,Ph.D.
Seoul National University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2014
First Posted
April 4, 2014
Study Start
July 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 4, 2014
Record last verified: 2014-04