Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

Santen

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Methacholine Chloride (SK-1211)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02097537

MC1002

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Methacholine Chloride

Experimental group

Description:

children with bronchial asthma

Treatment:

Drug: Methacholine Chloride (SK-1211)