Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00480649
First received: May 30, 2007
Last updated: November 8, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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, 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 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 June 18, 2013