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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

May 30, 2007
November 8, 2012
January 2004
September 2005   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00480649 on ClinicalTrials.gov Archive Site
Secondary measures of efficacy consist of clinical efficacy and health outcome measurements. [ Time Frame: 52 weeks after randomization ] [ Designated as safety issue: No ]
Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.
Not Provided
Not Provided
 
Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS)
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
Drug: Salmeterol/ fluticasone propionate
2 active arms (parellel group)
Other Name: SERETIDE
  • Active Comparator: Sal/FP 50/250mcg
    SERETIDE 50/250
    Intervention: Drug: Salmeterol/ fluticasone propionate
  • Active Comparator: Sal/FP 50/500mcg
    SERETIDE 50/500
    Intervention: Drug: Salmeterol/ fluticasone propionate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
424
September 2005
September 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00480649
100614
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP