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NCT02100267 Clinical Trial

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

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02100267
Other study ID # MC1001
Secondary ID
Status Completed
Phase Phase 3
First received March 24, 2014
Last updated November 13, 2014
Start date April 2014
Est. completion date September 2014

Study information
Verified date March 2014
Source Sanwa Kagaku Kenkyusho Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers
Gender Both
Age group 20 Years to 64 Years
Eligibility 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

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Methacholine Chloride (SK-1211)
Subjects received saline and 0.039-25 mg/mL of Methacholine chloride

Locations
Country Name City State
Japan Showa University Clinical Research Center Setagaya-ku Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Sanwa Kagaku Kenkyusho Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL) Provocative concentration causing a 20% fall(PC20) will be captured once at visit 2. Visit 2 (Day 1)
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