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Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Methacholine Chloride (SK-1211)
Sponsored by
Santen Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Santen study sites

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Methacholine Chloride

Arm Description

children with bronchial asthma

Outcomes

Primary Outcome Measures

The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL
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.

Secondary Outcome Measures

The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation
The Summary Statistics of PC20
PC20 : the concentration of methacholine causing 20% fall in FEV1.

Full Information

First Posted
March 19, 2014
Last Updated
February 27, 2017
Sponsor
Santen Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02097537
Brief Title
Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma
Official Title
Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methacholine Chloride
Arm Type
Experimental
Arm Description
children with bronchial asthma
Intervention Type
Drug
Intervention Name(s)
Methacholine Chloride (SK-1211)
Primary Outcome Measure Information:
Title
The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL
Description
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.
Time Frame
Visit 1 (Day 1)
Secondary Outcome Measure Information:
Title
The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation
Time Frame
Visit 1 (Day 1)
Title
The Summary Statistics of PC20
Description
PC20 : the concentration of methacholine causing 20% fall in FEV1.
Time Frame
Visit 1 (Day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Santen study sites
City
Osaka
Country
Japan

12. IPD Sharing Statement

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