No Resistance After Long Term Treatment SERETIDE

NCT ID: NCT00456313

Last Updated: 2015-04-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2007-12-31

Brief Summary

This multi centre, double blind, comparator controlled, parallel group study is to determine whether asthma treatment with high doses of fluticasone propionate (FP) redirects a Th2/ eosinophil response towards a more treatment resistant neutrophil/ monocyte response and whether this occurs to a lesser extent in asthmatic subjects treated with the combination product of salmeterol and fluticasone propionate (SFC). The primary endpoint is the mean change in priming of blood neutrophils assessed by marker A17. After a run-in period of 4 weeks subjects will enter a 24 weeks high dose treatment (FP 500 mcg bd) or a 12 week medium-dose treatment with FP 250 mcg bd followed by a 12 week treatment with SFC 50/ 250 mcg. At the visits lung function measurements, ACT, eNO measurements and a blood sample will be performed. A total of 50 randomised subjects are planned to be recruited in this study

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

arm 1

Group Type: ACTIVE_COMPARATOR

FLIXOTIDE and SERETIDE

Intervention Type: DRUG

comparator

Interventions

FLIXOTIDE and SERETIDE

comparator

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Positive skin prick test
• History of asthma (GINA)
• Regular treatment with FP with/without LABA at least 4 weeks before visit 1
• History of recurrent episodes of wheezing, breathlessness, chest tightness and/ or coughing in the previous year.
• Able to use a DISKUS™ inhaler
• Able perform reproducible lung function tests at Visit 1

• FEV1 % predicted > 70%
• ACT score < 25 after run-in period

Exclusion Criteria

• Hospitalised for asthma within 4 weeks prior to Visit 1
• Acute upper respiratory tract infection or a lower respiratory tract infection within 4 weeks prior to Visit 1
• Oral, parental or depot corticosteroids within 4 weeks prior to Visit 1
• Hepatic impairment or other significant disease

• Non-compliance (< 70%)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

GSK

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Utrecht, , Netherlands

GSK Investigational Site

Utrecht, , Netherlands

Countries

Netherlands

Other Identifiers

SAM109352

Identifier Type: -

Identifier Source: org_study_id