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

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Salmeterol/ fluticasone propionate

• Registration Number: NCT00480649
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-30
• Study First Posted: 2007-05-31
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 424

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sal/FP 50/500mcg	Salmeterol/ fluticasone propionate	SERETIDE 50/500
Sal/FP 50/250mcg	Salmeterol/ fluticasone propionate	SERETIDE 50/250

Primary Outcome Measures

Name	Time	Method
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.	52 weeks after randomization

Secondary Outcome Measures

Name	Time	Method
Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.	52 weeks after randomization

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 전주시, Korea, Republic of