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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02100267

Enrollment

Unknown

Registered

2014-03-31

Start date

2014-04-30

Completion date

2014-09-30

Last updated

2014-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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

Interventions

DRUGMethacholine Chloride (SK-1211)

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

Study design

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

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

Design outcomes

Primary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026