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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Showa University Clinical Research Center

Setagaya-ku, Tokyo, 157-8577, Japan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methacholine Chloride (SK-1211)

Drug

Subjects received saline and 0.039-25 mg/mL of Methacholine chloride

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Mar 31, 2014
Registry last updated: Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed