Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Pharmaceutical Co., Ltd.
• Treatments: Methacholine Chloride

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