Clinical trial NCT00480649: Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: SERETIDE
asthma
Korean
ACT
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-05-31
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
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.
timeFrame: 52 weeks after randomization
Secondary outcomes:
measure: Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.
timeFrame: 52 weeks after randomization
Other outcomes:
Locations:
city: Anyang-Si
country: Korea, Republic of
facility: GSK Investigational Site
city: Busan-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Junjoo-Si
country: Korea, Republic of
facility: GSK Investigational Site
city: Kyungki-Do Anyang-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Kyungki-Do
country: Korea, Republic of
facility: GSK Investigational Site
city: Pusan
country: Korea, Republic of
facility: GSK Investigational Site
city: Pusan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: 서울시
country: Korea, Republic of
facility: GSK Investigational Site
city: 전주시
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.