AsthmaPhase 4NCT00480649
Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS)
A Phase 4 study testing Salmeterol/ fluticasone propionate in people with Asthma, run by GlaxoSmithKline at 12 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Salmeterol/ fluticasone propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 12 sitesSouth Korea
- Study dates
- Jan 2004to Sep 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
GSK Investigational Site
Anyang-si, 431-070
GSK Investigational Site
Busan
GSK Investigational Site
Jeonju
GSK Investigational Site
Junjoo-Si
GSK Investigational Site
Kyungki-Do
GSK Investigational Site
Kyungki-Do Anyang-si
GSK Investigational Site
Pusan, 602-739
GSK Investigational Site
Pusan
GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Seoul, 140-743
GSK Investigational Site
Seoul, 152-703
GSK Investigational Site
Seoul
About this study
Official title: 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
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.
- Conditions
- Asthma
- Being tested
- Salmeterol/ fluticasone propionate
- Keywords
- SERETIDE, asthma, Korean, ACT
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol/ fluticasone propionateDrug
Also called SERETIDE
2 active arms (parellel group)
| Study group | Role | What they receive |
|---|---|---|
| Sal/FP 50/250mcg | Active comparator | SERETIDE 50/250 Receives: Drug: Salmeterol/ fluticasone propionate |
| Sal/FP 50/500mcg | Active comparator | SERETIDE 50/500 Receives: Drug: Salmeterol/ fluticasone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks after randomization
Secondary outcomes (1)
Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.
Measured: 52 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startJan 2004
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480649
- Sponsor's protocol ID
- 100614
- Status last verified
- Nov 2012
- First submitted
- 30 May 2007
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00480649
- Acronym / sponsor ID
- 100614
- Conditions
- Asthma
- Keywords
- SERETIDE, asthma, Korean, ACT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 31 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sal/FP 50/250mcg | Active comparator | Drug: Salmeterol/ fluticasone propionateSERETIDE 50/250 |
| Sal/FP 50/500mcg | Active comparator | Drug: Salmeterol/ fluticasone propionateSERETIDE 50/500 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salmeterol/ fluticasone propionateAlso: SERETIDE2 active arms (parellel group) | Drug | Sal/FP 50/250mcg, Sal/FP 50/500mcg |
Primary outcome
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
1 secondary outcome
Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.
Time frame: 52 weeks after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
- Background: PubMed 19032138Jung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salmeterol/ fluticasone propionate in people with Asthma, run by GlaxoSmithKline at 12 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00480649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2012.