No Resistance After Long Term Treatment SERETIDE

• Status: Withdrawn
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination

Criteria

Inclusion:

• 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

Inclusion criteria treatment period:

• FEV1 % predicted > 70%

• ACT score < 25 after run-in period

Exclusion criteria run-in period:

• 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

Exclusion criteria treatment period:

• Non-compliance (< 70%)