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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