Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS) - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00480649

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Salmeterol/ fluticasone propionate	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary measures of efficacy consist of clinical efficacy and health outcome measurements. [ Time Frame: 52 weeks after randomization ] [ Designated as safety issue: No ]

Enrollment:	424
Study Start Date:	January 2004
Study Completion Date:	September 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Sal/FP 50/250mcg SERETIDE 50/250	Drug: Salmeterol/ fluticasone propionate 2 active arms (parellel group) Other Name: SERETIDE
Active Comparator: Sal/FP 50/500mcg SERETIDE 50/500	Drug: Salmeterol/ fluticasone propionate 2 active arms (parellel group) Other Name: SERETIDE

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480649

Locations

Korea, Republic of
GSK Investigational Site
Anyang-Si, Korea, Republic of, 431-070
GSK Investigational Site
Busan, Korea, Republic of
GSK Investigational Site
Busan-si, Korea, Republic of
GSK Investigational Site
Junjoo-Si, Korea, Republic of
GSK Investigational Site
Kyungki-Do, Korea, Republic of
GSK Investigational Site
Kyungki-Do Anyang-si, Korea, Republic of
GSK Investigational Site
Pusan, Korea, Republic of, 602-739
GSK Investigational Site
Pusan, Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 140-743
GSK Investigational Site
Seoul, Korea, Republic of, 152-703
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of
GSK Investigational Site
서울시, Korea, Republic of
GSK Investigational Site
전주시, Korea, Republic of

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

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.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00480649 History of Changes
Other Study ID Numbers:	100614
Study First Received:	May 30, 2007
Last Updated:	January 19, 2012
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by GlaxoSmithKline:

SERETIDE
asthma
Korean
ACT

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Fluticasone, salmeterol drug combination
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

ClinicalTrials.gov processed this record on February 09, 2012