NCT01740986

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2012

Typical duration for phase_2

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 16, 2015

Status Verified

January 1, 2015

Enrollment Period

2.7 years

First QC Date

November 30, 2012

Last Update Submit

November 13, 2015

Conditions

Mild to Moderate Bronchial Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

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

    6 week treatment period

Secondary Outcomes (3)

  • 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

Study Arms (3)

SA09012 Low dose

EXPERIMENTAL
Drug: SA09012 Low dose

SA09012 High dose

EXPERIMENTAL
Drug: SA09012 High dose

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SA09012 Low doseDRUG

Tablet, b.i.d

SA09012 Low dose
SA09012 High doseDRUG

Tablet, b.i.d

SA09012 High dose
PlaceboDRUG

Tablet, b.i.d

Placebo

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient who has severe asthma
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Chonbuk National University Hospital

Chonbuk, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Ajou University Hospital

Gyeonggi-do, South Korea

Location

Bucheon St. Mary's Hospital, The Catholic University of Korea

Gyeonggi-do, South Korea

Location

Hallym University Sacred Heart Hospital

Gyeonggi-do, South Korea

Location

Soon Chun Hyang University Bucheon Hospital

Gyeonggi-do, South Korea

Location

Chungbuk National University Hospital

Jungbuk, South Korea

Location

Konkuk University Medical Center

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

KyungHee University Medical Center

Seoul, South Korea

Location

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

Location

Soonchunhyang University Hospital, Seoul

Seoul, South Korea

Location

St. Paul's Hospital, The Catholic University of Korea

Seoul, South Korea

Location

Yonsei University, Gangnam Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Young Kyoon Kim, MD

    Seoul ST. Mary's Hospital The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 4, 2012

Study Start

November 1, 2012

Primary Completion

July 1, 2015

Study Completion

November 1, 2015

Last Updated

November 16, 2015

Record last verified: 2015-01

Locations

KR(14)