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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Salmeterol/ fluticasone propionate
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring SERETIDE, asthma, Korean, ACT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sal/FP 50/250mcg

Sal/FP 50/500mcg

Arm Description

SERETIDE 50/250

SERETIDE 50/500

Outcomes

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.

Full Information

First Posted
May 30, 2007
Last Updated
November 8, 2012
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00480649
Brief Title
Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS)
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 Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
SERETIDE, asthma, Korean, ACT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
424 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sal/FP 50/250mcg
Arm Type
Active Comparator
Arm Description
SERETIDE 50/250
Arm Title
Sal/FP 50/500mcg
Arm Type
Active Comparator
Arm Description
SERETIDE 50/500
Intervention Type
Drug
Intervention Name(s)
Salmeterol/ fluticasone propionate
Other Intervention Name(s)
SERETIDE
Intervention Description
2 active arms (parellel group)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.
Time Frame
52 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Anyang-Si
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Busan-si
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Busan
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Junjoo-Si
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Kyungki-Do Anyang-si
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Kyungki-Do
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Pusan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Pusan
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
140-743
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
서울시
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
전주시
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19032138
Citation
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.
Results Reference
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Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS)

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