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

Sponsored by:	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

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone Fluticasone propionate Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

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.

Secondary Outcome Measures:

Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.

Estimated Enrollment:	500
Study Start Date:	December 2003

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, M.D., PH.D.

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	100614
Study First Received:	May 30, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00480649
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by GlaxoSmithKline:

asthma
seretide
ACT
Korean

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Salmeterol
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Fluticasone
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Anti-Asthmatic Agents
Anti-Allergic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 13, 2009