NCT02100267

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2014

Shorter than 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

First Submitted

Initial submission to the registry

March 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 17, 2014

Status Verified

March 1, 2014

Enrollment Period

5 months

First QC Date

March 24, 2014

Last Update Submit

November 13, 2014

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Asthma patients

EXPERIMENTAL
Drug: Methacholine Chloride (SK-1211)

Healthy volunteers

EXPERIMENTAL
Drug: Methacholine Chloride (SK-1211)

Interventions

Methacholine Chloride (SK-1211)DRUG

Subjects received saline and 0.039-25 mg/mL of Methacholine chloride

Asthma patientsHealthy volunteers

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa University Clinical Research Center

Setagaya-ku, Tokyo, 157-8577, 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

Study Design

Study Type
interventional
Phase
phase 3
Purpose
DIAGNOSTIC
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 31, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 17, 2014

Record last verified: 2014-03

Locations

JP(1)