NCT02097537

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

February 14, 2017

Completed
Last Updated

March 29, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

March 19, 2014

Results QC Date

December 20, 2016

Last Update Submit

February 27, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)

Study Arms (1)

Methacholine Chloride

EXPERIMENTAL

children with bronchial asthma

Drug: Methacholine Chloride (SK-1211)

Interventions

Methacholine Chloride (SK-1211)DRUG
Methacholine Chloride

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of bronchial asthma
  • FEV1/FVC must be 70% or more
  • \<10% decrease in FEV1 in response to inhalation of normal saline

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santen study sites

Osaka, Osaka, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

Methacholine Chloride

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Methacholine CompoundsTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Results Point of Contact

Title
General Manager of Clinical Development Group
Organization
Santen Pharmaceutical Co., Ltd.
clinical@santen.co.jp

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 27, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2014

Last Updated

March 29, 2017

Results First Posted

February 14, 2017

Record last verified: 2017-02

Locations

JP(1)