Back to resultsA Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Methacholine Chloride (SK-1211)
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- FEV1/forced vital capacity(FVC) must be 70% or more
- <10% decrease in FEV1 in response to inhalation of normal saline
Exclusion Criteria:
- Moderate airflow limitation (FEV1 < 60% predicted or < 1.5 L)
- Heart attack or stroke in last 3 months
- Uncontrolled hypertension, systolic BP>200, or diastolic BP>100
Sites / Locations
- Showa University Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Asthma patients
Healthy volunteers
Arm Description
Outcomes
Primary Outcome Measures
Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL)
Provocative concentration causing a 20% fall(PC20) will be captured once at visit 2.
Secondary Outcome Measures
Full Information
NCT ID
NCT02100267
First Posted
March 24, 2014
Last Updated
November 13, 2014
Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02100267
Brief Title
A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Arm Title
Asthma patients
Arm Type
Experimental
Arm Title
Healthy volunteers
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methacholine Chloride (SK-1211)
Intervention Description
Subjects received saline and 0.039-25 mg/mL of Methacholine chloride
Primary Outcome Measure Information:
Title
Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL)
Description
Provocative concentration causing a 20% fall(PC20) will be captured once at visit 2.
Time Frame
Visit 2 (Day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Eligibility Criteria
Inclusion Criteria:
FEV1/forced vital capacity(FVC) must be 70% or more
<10% decrease in FEV1 in response to inhalation of normal saline
Exclusion Criteria:
Moderate airflow limitation (FEV1 < 60% predicted or < 1.5 L)
Heart attack or stroke in last 3 months
Uncontrolled hypertension, systolic BP>200, or diastolic BP>100
Facility Information:
Facility Name
Showa University Clinical Research Center
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8577
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma
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