Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

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: Asthma
• Intervention / Treatment: Drug: Methacholine Chloride (SK-1211)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Santen study sites

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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		Visit 1 (Day 1)
The Summary Statistics of PC20	PC20 : the concentration of methacholine causing 20% fall in FEV1.	Visit 1 (Day 1)

Collaborators and Investigators

• Sponsor: Santen Pharmaceutical Co., Ltd.

Study record dates

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: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Respiratory System Agents; Miotics; Parasympathomimetics; Bronchoconstrictor Agents; Muscarinic Agonists; Methacholine Chloride
• Other Study ID Numbers: MC1002