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

November 13, 2014 updated by: Sanwa Kagaku Kenkyusho Co., Ltd.
The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Setagaya-ku, Tokyo, Japan, 157-8577
        • Showa University Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers
Drug: Methacholine Chloride (SK-1211)
Subjects received saline and 0.039-25 mg/mL of Methacholine chloride
Experimental: Asthma patients
Drug: Methacholine Chloride (SK-1211)
Subjects received saline and 0.039-25 mg/mL of Methacholine chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Visit 2 (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 31, 2014

Study Record Updates

Last Update Posted (Estimate)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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