Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

Asthma Clinical Trial

Official title:

Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097537
• Other study ID #: MC1002
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2014
• Last updated: November 11, 2015

Study information

• Verified date: November 2015
• Source: Santen Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Methacholine Chloride (SK-1211)

Locations

Country	Name	City	State
Japan	Santen study sites	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of subjects whose PC20, the concentration of methacholine that would provoke a fall in FEV1 of 20%, is less than 8mg/mL	PC20 will be captured once at visit 1	Visit 1 (Day 1)