Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS)
SUccessful Control and Clinical Effectiveness of SERETIDE Study in aSthma, a Randomised Controlled Study to Investigate the Clinical Effectiveness and Health Outcome of SERETIDE in Patients With Moderate and Severe Persistent Asthma in Korea
1 other identifier
interventional
424
1 country
12
Brief Summary
The primary study objective is to demonstrate the clinical effectiveness of SERETIDE therapy compared to the current care in management of moderate to severe persistent asthma patients in Korea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Jan 2004
12 active sites
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
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 30, 2007
CompletedFirst Posted
Study publicly available on registry
May 31, 2007
CompletedNovember 12, 2012
November 1, 2012
1.7 years
May 30, 2007
November 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy endpoint for this trial is mean morning PEFR LOCF at 52 weeks as collected in diary cards over the last 2 weeks preceding the 52 weeks visit.
52 weeks after randomization
Secondary Outcomes (1)
Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.
52 weeks after randomization
Study Arms (2)
Sal/FP 50/250mcg
ACTIVE COMPARATORSERETIDE 50/250
Sal/FP 50/500mcg
ACTIVE COMPARATORSERETIDE 50/500
Interventions
2 active arms (parellel group)
Eligibility Criteria
You may qualify if:
- Male or female subjects aged 18 years and over who are willing to give a written consent to participate in the study.
- Subjects with a documented clinical history of reversible airways obstruction (history taking is acceptable) for at least 12 months and, in the opinion of the investigator, is able to comply with therapy and to complete the Daily Record Cards (DRCs) correctly.
- Subjects able to demonstrate the ability to effectively (physically and/or mentally) use a DISKUS (a dummy DISKUS provided for test).
- A female is eligible to enter and participate in this study
- Subjects with access to telephone (mobile or landline at home)
You may not qualify if:
- Previous use of ICS /LABA combination inhaler (SYMBICORT (Astrazeneca) or SERETIDE) 12 weeks prior to Visit 1.
- Subjects with known or suspected hypersensitivity to inhaled steroids or Beta2-agonists.
- Subjects who have had other changes in their regular asthma medication within 2 weeks of Visit 1.
- Subjects who have had a lower respiratory tract infection within 4 weeks of Visit 1.
- Subjects who have a smoking history of 10 pack years (e.g. 10 cigarettes/day for 20 years or 20 cigarettes/day for 10 years or 40 cigarettes/day for 5 years) or more at the time of Visit 1 (Current smoker can be included even if his/her smoking history is less than 10 pack years at the time of Visit 1).
- Subjects who suffer from serious, uncontrolled diseases (including serious psychological disorders) likely to interfere with the study.
- Subjects who are on immunotherapy
- Subjects who have taken any investigational drugs within 4 weeks of Visit 1.
- Subjects who have, in the opinion of the investigator, evidence of alcohol or drug abuse.
- Females who are pregnant, lactating or are of child bearing potential and are likely to become pregnant. Females of childbearing age may be included if, in the opinion of the investigator, they are exerting adequate contraceptive precautions.
- Subjects who have previously been enrolled into this study
- Patients on regular oral or parenteral steroid therapy in the last 4 weeks or more than 3 courses of steroid in the last 6 months
- Subjects who have FEV1 or PEFR of less than 50% predictive value.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (12)
GSK Investigational Site
Anyang-si, 431-070, South Korea
GSK Investigational Site
Busan, South Korea
GSK Investigational Site
Jeonju, South Korea
GSK Investigational Site
Junjoo-Si, South Korea
GSK Investigational Site
Kyungki-Do Anyang-si, South Korea
GSK Investigational Site
Kyungki-Do, South Korea
GSK Investigational Site
Pusan, 602-739, South Korea
GSK Investigational Site
Pusan, South Korea
GSK Investigational Site
Seoul, 120-752, South Korea
GSK Investigational Site
Seoul, 140-743, South Korea
GSK Investigational Site
Seoul, 152-703, South Korea
GSK Investigational Site
Seoul, South Korea
Related Publications (1)
Jung KS, Uh ST, Lee YC, Shim JJ, Park SK, Williams AE, Chan R. Comparison of the clinical efficacy and safety of salmeterol/fluticasone propionate versus current care in the management of persistent asthma in Korea. Curr Med Res Opin. 2008 Dec;24(12):3571-82. doi: 10.1185/03007990802588737.
PMID: 19032138BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2007
First Posted
May 31, 2007
Study Start
January 1, 2004
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
November 12, 2012
Record last verified: 2012-11