Last updated: 11/02/2018 23:14:25
Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone propionate) Study In Asthma.(SUCCESS)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: 52 weeks after randomization
Secondary outcomes:
Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.
Timeframe: 52 weeks after randomization
Interventions:
Drug: Salmeterol/ fluticasone propionate
Enrollment:
424
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Jung KS, Uh ST, Lee YC, et al. 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;24(12):3571–82.
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
January 2004 to September 2005
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
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:
- 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-16-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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