A Study to Evaluate Efficacy and Safety of Methacholine C... | NCT02100267

Studies
A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma

NCT02100267

Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Status

Completed

Last Update Posted

Nov 17, 2014Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Asthma

Interventions

Methacholine Chloride (SK-1211)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Mar 24, 2014

First Submission Date that Met QC Criteria

Mar 26, 2014

First Posted Date

Mar 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2014

Last Update Posted Date

Nov 17, 2014Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Asthma patients	Experimental		Drug: Methacholine Chloride (SK-1211)
Healthy volunteers	Experimental		Drug: Methacholine Chloride (SK-1211)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methacholine Chloride (SK-1211)	Drug	Subjects received saline and 0.039-25 mg/mL of Methacholine chloride	Asthma patients Healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL)	Provocative concentration causing a 20% fall(PC20) will be captured once at visit 2.	Visit 2 (Day 1)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

FEV1/forced vital capacity(FVC) must be 70% or more
<10% decrease in FEV1 in response to inhalation of normal saline

Exclusion Criteria:

Moderate airflow limitation (FEV1 < 60% predicted or < 1.5 L)
Heart attack or stroke in last 3 months
Uncontrolled hypertension, systolic BP>200, or diastolic BP>100

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Showa University Clinical Research Center		Setagaya-ku	Tokyo	157-8577	Japan

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016210	Methacholine Chloride

Ancestor Terms

ID	Term
D008688	Methacholine Compounds
D050337	Trimethyl Ammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines

Browse Leaves

Not provided

Browse Branches

Not provided