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CompletedNCT00480649Updated Nov 12, 2012

Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS)

A Phase 4 interventional study of Salmeterol/ fluticasone propionate in Asthma, sponsored by GlaxoSmithKline. Completed at 14 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-12.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
424
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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Keywords

  • SERETIDE
  • asthma
  • Korean
  • ACT
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 424 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
424 participants (actual)

Study arms

  • Active comparator
    Sal/FP 50/250mcg

    SERETIDE 50/250

    Drug: Salmeterol/ fluticasone propionate

  • Active comparator
    Sal/FP 50/500mcg

    SERETIDE 50/500

    Drug: Salmeterol/ fluticasone propionate

Interventions

  • DrugSalmeterol/ fluticasone propionate

    2 active arms (parellel group)

    Also known as: SERETIDE

06

What researchers measure

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.

    Time frame: 52 weeks after randomization

Secondary outcomes

  1. Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.

    Time frame: 52 weeks after randomization

07

Study locations

14 sites
  • GSK Investigational Site
    Anyang-Si, 431-070, Korea, Republic of
  • GSK Investigational Site
    Busan-si, Korea, Republic of
  • GSK Investigational Site
    Busan, Korea, Republic of
  • GSK Investigational Site
    Junjoo-Si, Korea, Republic of
  • GSK Investigational Site
    Kyungki-Do Anyang-si, Korea, Republic of
  • GSK Investigational Site
    Kyungki-Do, Korea, Republic of
  • GSK Investigational Site
    Pusan, 602-739, Korea, Republic of
  • GSK Investigational Site
    Pusan, Korea, Republic of
  • GSK Investigational Site
    Seoul, 120-752, Korea, Republic of
  • GSK Investigational Site
    Seoul, 140-743, Korea, Republic of
  • GSK Investigational Site
    Seoul, 152-703, Korea, Republic of
  • GSK Investigational Site
    Seoul, Korea, Republic of
  • GSK Investigational Site
    서울시, Korea, Republic of
  • GSK Investigational Site
    전주시, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 19032138 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00480649
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
May 31, 2007
Start date
Jan 2004
Primary completion
Sep 2005
Completion
Sep 2005
Last update
Nov 12, 2012

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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