Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS)
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Salmeterol/Fluticasone propionate (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, M.D., PH.D., Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.
Secondary outcome: Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 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.
Locations and Contacts
GSK Clinical Trials Call Center, Chonju City, Chonbuk 561-712, Korea, Republic of
GSK Clinical Trials Call Center, Seoul 152-050, Korea, Republic of
GSK Clinical Trials Call Center, Pusan 602-739, Korea, Republic of
GSK Clinical Trials Call Center, Pusan 602-714, Korea, Republic of
GSK Clinical Trials Call Center, Pusan 614-735, Korea, Republic of
GSK Clinical Trials Call Center, Seoul 140-743, Korea, Republic of
GSK Clinical Trials Call Center, Kyung-ki Do 431-070, Korea, Republic of
Additional Information
Starting date: December 2003
Last updated: October 24, 2007
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