A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Methacholine Chloride (SK-1211)

• Registration Number: NCT02100267
• Lead Sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.

Brief Summary

The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-31
• Study Start: 2014-04
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Methacholine Chloride (SK-1211)	-
Asthma patients	Methacholine Chloride (SK-1211)	-

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL)	Visit 2 (Day 1)	Provocative concentration causing a 20% fall(PC20) will be captured once at visit 2.

Trial Locations

Locations (1)

Showa University Clinical Research Center; 🇯🇵 Setagaya-ku, Tokyo, Japan