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

Sanwa Kagaku Kenkyusho

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Methacholine Chloride (SK-1211)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02100267

MC1001

Details and patient eligibility

About

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

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Asthma patients

Experimental group

Treatment:

Drug: Methacholine Chloride (SK-1211)

Healthy volunteers

Experimental group

Treatment:

Drug: Methacholine Chloride (SK-1211)