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Completed

NCT Number: NCT01740986

Safety and Efficacy of SA09012 in Asthma

Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients

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Key information

Conditions

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

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chonbuk National University Hospital, Chonbuk, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis or presence of asthma within 3 months of the prestudy visit
  • Increase in PEF ≥ 20% or ≥ 60L/min from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
  • Increase in FEV1 ≥ 12% and ≥ 200mL from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
  • FEV1 or PEF between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit
  • Having signed an informed consent

Exclusion criteria

  • Patient who has severe asthma
  • Patient who has any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study other protocol-defined inclusion/exclusion criteria may apply
  • Patient with an AST or ALT > 2x ULN (upper limit of normal) in the screening visit
  • Patient with more than 10 pack year of cigarettes history

Treatment and study plan

SA09012 Low dose

Drug

Tablet, b.i.d

SA09012 High dose

Drug

Tablet, b.i.d

Placebo

Drug

Tablet, b.i.d

Primary outcomes

  1. Mean change from baseline of PEF(Peak Expiratory Flow)at week 6

    Time frame: 6 week treatment period

Secondary outcomes

  1. Mean change from baseline in FEV1 at week 6

    Time frame: 6 week treatment period

  2. Mean change from baseline in ACT(Asthma Control Test) at week 6

    Time frame: 6 week treatment period

  3. Safety assessment(Comparison of the adverse event profiles throughout the course of the study)

    Time frame: 6 week treatment period

Sponsors and collaborators

Lead sponsor

SamA Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase II Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2012
Registry last updated
Nov 16, 2015

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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