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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480649
• Other study ID #: 100614
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2007
• Last updated: November 8, 2012
• Start date: January 2004
• Est. completion date: September 2005

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salmeterol/ fluticasone propionate
2 active arms (parellel group)

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	???
Korea, Republic of	GSK Investigational Site	???
Korea, Republic of	GSK Investigational Site	Anyang-Si
Korea, Republic of	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	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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 . — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary measures of efficacy consist of clinical efficacy and health outcome measurements.		52 weeks after randomization	No