Safety and Efficacy of SA09012 in Asthma

Phase 2

Completed

• Conditions: Mild to Moderate Bronchial Asthma
• Interventions: Drug: SA09012 Low dose; Drug: SA09012 High dose; Drug: Placebo

• Registration Number: NCT01740986
• Lead Sponsor: SamA Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Status Verified: 2015-01
• Primary Completion: 2015-07
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-13
• Last Update Posted: 2015-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SA09012 Low dose	SA09012 Low dose	-
SA09012 High dose	SA09012 High dose	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline of PEF(Peak Expiratory Flow)at week 6	6 week treatment period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (14)

Chonbuk National University Hospital; 🇰🇷 Chonbuk, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

KyungHee University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Yonsei University, Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Ajou University Hospital; 🇰🇷 Gyeonggi, Korea, Republic of

Chungbuk National University Hospital; 🇰🇷 Chungbuk, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Gyeonggi, Korea, Republic of

Bucheon St. Mary's Hospital, The Catholic University of Korea; 🇰🇷 Gyeonggi, Korea, Republic of

Soon Chun Hyang University Bucheon Hospital; 🇰🇷 Gyeonggi, Korea, Republic of

St. Paul's Hospital, The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of

Seoul St. Mary's Hospital, The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang University Hospital, Seoul; 🇰🇷 Seoul, Korea, Republic of