Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

NCT ID: NCT02097537

Last Updated: 2017-03-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Brief Summary

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The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation challenge in children with bronchial asthma.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Methacholine Chloride

children with bronchial asthma

Group Type EXPERIMENTAL

Methacholine Chloride (SK-1211)

Intervention Type DRUG

Interventions

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Methacholine Chloride (SK-1211)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of bronchial asthma
* FEV1/FVC must be 70% or more
* \<10% decrease in FEV1 in response to inhalation of normal saline

Exclusion Criteria

* Moderate or severe airflow limitation(FEV1\<60% predicted)
* Heart attack or stroke in last 3 months
* Uncontrolled hypertension, systolic BP\>200, or diastolic BP\>100
* known aortic aneurysm
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santen Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Santen study sites

Osaka, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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MC1002

Identifier Type: -

Identifier Source: org_study_id

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