Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

February 27, 2017 updated by: Santen Pharmaceutical Co., Ltd.
The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation challenge in children with bronchial asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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
      • Osaka, Japan
        • Santen study sites

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

6 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Methacholine Chloride
children with bronchial asthma
Drug: Methacholine Chloride (SK-1211)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL
Time Frame: Visit 1 (Day 1)

The methacholine challenge test is for assessment of bronchial sensitivity, it is assessed by FEV1 (Forced Expiratory Volume in one second) with spirometer.

For measurement of FEV1, a patient is inhaled saline as baseline and each dose of methacholine which be gradually diluted, inhalations are discontinued with a drop in FEV1 of 20% or more.

The concentration of methacholine causing 20% fall in FEV1 is PC20.
Visit 1 (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation
Time Frame: Visit 1 (Day 1)
Visit 1 (Day 1)
The Summary Statistics of PC20
Time Frame: Visit 1 (Day 1)
PC20 : the concentration of methacholine causing 20% fall in FEV1.
Visit 1 (Day 1)

Collaborators and Investigators

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

Sponsor

Santen Pharmaceutical 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

February 1, 2014

Primary Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (ESTIMATE)

March 27, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC1002

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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