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Safety and Efficacy of SA09012 in Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740986
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : November 16, 2015
Sponsor:
Information provided by (Responsible Party):
SamA Pharmaceutical Co., Ltd

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

Condition or disease Intervention/treatment Phase
Mild to Moderate Bronchial Asthma Drug: SA09012 Low dose Drug: SA09012 High dose Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: SA09012 Low dose Drug: SA09012 Low dose
Tablet, b.i.d

Experimental: SA09012 High dose Drug: SA09012 High dose
Tablet, b.i.d

Placebo Comparator: Placebo Drug: Placebo
Tablet, b.i.d




Primary Outcome Measures :
  1. Mean change from baseline of PEF(Peak Expiratory Flow)at week 6 [ Time Frame: 6 week treatment period ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740986


Locations
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Korea, Republic of
Chonbuk National University Hospital
Chonbuk, Korea, Republic of
Chungbuk National University Hospital
Chungbuk, Korea, Republic of
Chonnam National University Hospital
Gwangju, 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
Gyeonggi, Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
KyungHee University Medical Center
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
St. Paul's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of
Yonsei University, Gangnam Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
SamA Pharmaceutical Co., Ltd
Investigators
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Principal Investigator: Young Kyoon Kim, MD Seoul ST. Mary's Hospital The Catholic University of Korea
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Responsible Party: SamA Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01740986    
Other Study ID Numbers: SA09012-P2
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: January 2015
Keywords provided by SamA Pharmaceutical Co., Ltd:
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases