Rationale for Therapy With Low Dose Steroids Combined With Long-acting beta2-agonists in Patients With Allergic Asthma: Redirecting Innate Immune Responses by Long-term Treatment With High Doses of Inhaled Steroids
Overview
- Phase
- Phase 4
- Intervention
- FLIXOTIDE and SERETIDE
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Locations
- 1
- Primary Endpoint
- Mean change in neutrophil priming in blood as assessed by marker A17
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
arm 1
Intervention: FLIXOTIDE and SERETIDE
Outcomes
Primary Outcomes
Mean change in neutrophil priming in blood as assessed by marker A17
Time Frame: on going
Secondary Outcomes
- Activation in markers such as A27, CD11b, L-selection, CD16, CD32, VLA-4 and CD66b in whole blood- Cytokine/chemokine determination by multiplex assay in cell free serum- Asthma control measured - Lung function: FEV1, FVC and PEF- eNO(on going)