Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS)
NCT ID: NCT00480649
Last Updated: 2012-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
424 participants
INTERVENTIONAL
2004-01-31
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sal/FP 50/250mcg
SERETIDE 50/250
Salmeterol/ fluticasone propionate
2 active arms (parellel group)
Sal/FP 50/500mcg
SERETIDE 50/500
Salmeterol/ fluticasone propionate
2 active arms (parellel group)
Interventions
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Salmeterol/ fluticasone propionate
2 active arms (parellel group)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Anyang-si, , South Korea
GSK Investigational Site
Busan, , South Korea
GSK Investigational Site
Jeonju, , South Korea
GSK Investigational Site
Junjoo-Si, , South Korea
GSK Investigational Site
Kyungki-Do Anyang-si, , South Korea
GSK Investigational Site
Kyungki-Do, , South Korea
GSK Investigational Site
Pusan, , South Korea
GSK Investigational Site
Pusan, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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100614
Identifier Type: -
Identifier Source: org_study_id