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Completed

NCT Number: NCT02097537

Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Santen study sites

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methacholine Chloride (SK-1211)

Drug

Primary outcomes

  1. The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL

    Time frame: Visit 1 (Day 1)

    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.

Secondary outcomes

  1. The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation

    Time frame: Visit 1 (Day 1)

  2. The Summary Statistics of PC20

    Time frame: Visit 1 (Day 1)

    PC20 : the concentration of methacholine causing 20% fall in FEV1.

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
First posted
Mar 27, 2014
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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