Safety and Efficacy of SA09012 in Asthma

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

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

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Bronchial Asthma
• Intervention / Treatment: Drug: SA09012 Low dose; Drug: SA09012 High dose; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chonbuk, Korea, Republic of
    • Chonbuk National University Hospital
  • Chungbuk, Korea, Republic of
    • Chungbuk National University Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Gyeonggi, Korea, Republic of
    • Ajou University Hospital
  • Gyeonggi, Korea, Republic of
    • Bucheon St. Mary's Hospital, The Catholic University of Korea
  • Gyeonggi, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Gyeonggi, Korea, Republic of
    • Soon Chun Hyang University Bucheon Hospital
  • Seoul, Korea, Republic of
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of
    • Kyunghee University Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Seoul St. Mary's Hospital, The Catholic University of Korea
  • Seoul, Korea, Republic of
    • Yonsei University, Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • St. Paul's Hospital, The Catholic University of Korea
  • Seoul, Korea, Republic of
    • Soonchunhyang University Hospital, Seoul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis or presence of asthma within 3 months of the prestudy visit

  1. Increase in PEF ≥ 20% or ≥ 60L/min from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
  2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Tablet, b.i.d
Experimental: SA09012 Low dose	Drug: SA09012 Low dose; Tablet, b.i.d
Experimental: SA09012 High dose	Drug: SA09012 High dose; Tablet, b.i.d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline of PEF(Peak Expiratory Flow)at week 6	6 week treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in FEV1 at week 6	6 week treatment period
Mean change from baseline in ACT(Asthma Control Test) at week 6	6 week treatment period
Safety assessment(Comparison of the adverse event profiles throughout the course of the study)	6 week treatment period

Collaborators and Investigators

• Sponsor: SamA Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Young Kyoon Kim, MD, Seoul ST. Mary's Hospital The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: November 30, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Estimate): November 16, 2015
• Last Update Submitted That Met QC Criteria: November 13, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: SA09012-P2