Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Comparative Bronchial Provocation Study With Mannitol and Methacolinie in a Korean Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104284
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Information provided by (Responsible Party):
BL&H Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Asthma Procedure: methacholine and mannitol bronchial challenge tests Not Applicable

Detailed Description:

This study was a prospective, multicenter study performed at four referral hospitals in Korea: Seoul National University Hospital, Samsung Medical Center, Ajou University Hospital, and Hanyang University Medical Center. Hospital-based recruitment was performed for asthmatic patients and non-asthmatic controls. Asthmatic patients were defined as those who had been diagnosed with asthma by specialist physicians; they had recurrent symptoms of asthma (wheezing and dyspnea) and used anti-asthmatic medication for 6 months before the enrollment. Non-asthmatic controls were voluntarily recruited from hospital visitors; they were included if they had never wheeze or physician diagnosed asthma.

Common inclusion criteria were Korean adults between the age of 18 and 70 years who could understand and perform lung function tests and bronchial challenges. Exclusion criteria were any one of following: 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, or a pre-bronchodilator predictive value of forced expiratory volume in 1 second (FEV1) of <70%.

All participants underwent methacholine bronchial challenge test and mannitol challenge test on different days, separated by least 24 h, as in previous reports.7, 10 All asthmatic patients stopped their anti-asthma medications before the tests according to the predetermined protocols. The protocol was approved by the Institutional Review Board of Seoul National University Hospital. All subjects gave written informed consent.

Methacholine challenge test> The methacholine challenge test was performed as previously described.11, 12 Pulmonary function testing was carried out using a spirometry system (SensorMedics 2130; SensorMedics, CA, USA). The methacholine challenge test was performed using the Chai method13 with minor modifications. Briefly, methacholine was prepared at the following concentrations, diluted with saline: 0.25, 0.625, 1, 4, 16, and 25 mg/mL. Methacholine was delivered as an aerosol by a Rosenthal-French dosimeter (Laboratory for Applied Immunology, Inc., Baltimore, MD) and a nebulizer. Subjects were instructed to inhale five inspiratory capacity breaths while increasing the methacholine concentration from 0.25 to 25 mg/mL. The methacholine concentration that caused a 20% decrease in the FEV1 from baseline was defined as PC20. AHR was defined as positive at PC20 < 16 mg/mL.

Mannitol challenge test> A commercial mannitol (Aridol™; BL&H Co., Ltd., South Korea) kit was used, and the challenge test was performed according to the manufacturer's protocols.14 The mannitol capsule dose started at 0 mg and increased to a total cumulative dose of 635 mg. Each capsule was placed in the inhalation device, and a hole was made by pressing the device button before inhalation. After a deep breath of mannitol, the FEV1 was measured after 60 seconds. The test was considered positive if the FEV1 value decreased by more than 15% compared with the baseline FEV1. The cumulative mannitol dose that caused a 15% decrease in the FEV1 from baseline was defined as PD15. If the FEV1 did not decline by more than 15%, the dose was increased until a cumulative dose of 635 mg was reached. If the FEV1 did not fall by more than 15% until the last dose, the test was considered negative.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Comparative Bronchial Provocation Study With Mannitol and Methacolinie in a Korean Population
Study Start Date : July 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Normal controls, methacholine positive
methacholine and mannitol bronchial challenge tests: Positive methacholine challenge tests in normal controls
Procedure: methacholine and mannitol bronchial challenge tests

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.


Normal controls, mannitol
methacholine and mannitol bronchial challenge tests: Positive mannitol challenge tests in normal controls.
Procedure: methacholine and mannitol bronchial challenge tests

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.


Active Comparator: Asthma, Methacholine
methacholine and mannitol bronchial challenge tests: Positive methacholine challenge tests in asthmatics
Procedure: methacholine and mannitol bronchial challenge tests

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.


Active Comparator: Asthma, Mannitol
methacholine and mannitol bronchial challenge tests: Positive mannitol challenge tests in asthmatics
Procedure: methacholine and mannitol bronchial challenge tests

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.





Primary Outcome Measures :
  1. sensitivity comparison of the mannitol challenge test and methacholine challenge test [ Time Frame: 60 minutes ]

    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



Secondary Outcome Measures :
  1. specificity comparison of the mannitol challenge test and methacholine challenge test [ Time Frame: 60 minutes ]

    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

    specificity: true negative / false positive+true negative


  2. positive predictive value comparison of the mannitol challenge test and methacholine challenge test [ Time Frame: 60 minutes ]

    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

    positive predictive value: true positive / true positive+false positive


  3. negative predictive value comparison of the mannitol challenge test and methacholine challenge test [ Time Frame: 60 minutes ]

    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

    negative predictive value: true negative / true negative+false negative




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Common inclusion criteria were Korean adults between the age of 18 and 70 years who could understand and perform lung function tests and bronchial challenges.

Exclusion Criteria:

  • 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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104284


Sponsors and Collaborators
BL&H Co., Ltd
Investigators
Layout table for investigator information
Principal Investigator: Sang-Heon Cho, M.D.,Ph.D. Seoul National University College of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: BL&H Co., Ltd
ClinicalTrials.gov Identifier: NCT02104284     History of Changes
Other Study ID Numbers: mannitol-01
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: April 2014
Keywords provided by BL&H Co., Ltd:
Bronchial provocation test
Mannitol
Methacholine
Bronchial hyperreactivity
Sensitivity and specificity
Additional relevant MeSH terms:
Layout table for MeSH terms
Mannitol
Methacholine Chloride
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action