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

NCT ID: NCT02100267

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-09-30

Brief Summary

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

Detailed Description

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Conditions

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Asthma

Study Design

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Primary Study Purpose

DIAGNOSTIC

Study Groups

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Asthma patients

Group Type EXPERIMENTAL

Methacholine Chloride (SK-1211)

Intervention Type DRUG

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

Healthy volunteers

Group Type EXPERIMENTAL

Methacholine Chloride (SK-1211)

Intervention Type DRUG

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

Interventions

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Methacholine Chloride (SK-1211)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanwa Kagaku Kenkyusho Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Showa University Clinical Research Center

Setagaya-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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MC1001

Identifier Type: -

Identifier Source: org_study_id