Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Methacholine Chloride (SK-1211)

• Registration Number: NCT02097537
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-27
• Primary Completion: 2014-07
• Results First Submitted: 2016-12-20
• Results First Submitted QC: 2016-12-20
• Status Verified: 2017-02
• Results First Posted: 2017-02-14
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methacholine Chloride	Methacholine Chloride (SK-1211)	children with bronchial asthma

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Santen study sites; 🇯🇵 Osaka, Japan