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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00480649
First received: May 30, 2007
Last updated: November 8, 2012
Last verified: November 2012
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
GSK Investigational Site
Pusan, Korea, Republic of, 602-739
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 140-743
GSK Investigational Site
Seoul, Korea, Republic of, 152-703
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:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00480649     History of Changes
Other Study ID Numbers: 100614
Study First Received: May 30, 2007
Last Updated: November 8, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by GlaxoSmithKline:
SERETIDE
asthma
Korean
ACT

Additional relevant MeSH terms:
Asthma
Anti-Asthmatic Agents
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Fluticasone
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014