Clinical trial NCT01740986: Safety and Efficacy of SA09012 in Asthma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild to Moderate Bronchial Asthma
Keywords: Asthma
Lead sponsor: SamA Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-12-04
Enrollment: 225
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Mean change from baseline of PEF(Peak Expiratory Flow)at week 6
timeFrame: 6 week treatment period
Secondary outcomes:
measure: Mean change from baseline in FEV1 at week 6
timeFrame: 6 week treatment period
measure: Mean change from baseline in ACT(Asthma Control Test) at week 6
timeFrame: 6 week treatment period
measure: Safety assessment(Comparison of the adverse event profiles throughout the course of the study)
timeFrame: 6 week treatment period
Other outcomes:
Locations:
city: Chonbuk
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Chungbuk
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi
country: Korea, Republic of
facility: Ajou University Hospital
city: Gyeonggi
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital, The Catholic University of Korea
city: Gyeonggi
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Gyeonggi
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital, Seoul
city: Seoul
country: Korea, Republic of
facility: St. Paul's Hospital, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Yonsei University, Gangnam Severance Hospital
Study officials:
affiliation: Seoul ST. Mary's Hospital The Catholic University of Korea
name: Young Kyoon Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: