A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma
Overview
The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma
Study Type
- Study Type: Interventional
- Study Design
- Primary Purpose: Diagnostic
- Study Primary Completion Date: September 2014
Interventions
- Drug: Methacholine Chloride (SK-1211)
- Subjects received saline and 0.039-25 mg/mL of Methacholine chloride
Arms, Groups and Cohorts
- Experimental: Asthma patients
- Experimental: Healthy volunteers
Clinical Trial Outcome Measures
Primary Measures
- Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL)
- Time Frame: Visit 2 (Day 1)
- Provocative concentration causing a 20% fall(PC20) will be captured once at visit 2.
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 64 Years
Investigator Details
- Lead Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Provider of Information About this Clinical Study
- Sponsor
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