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Clinical Trials/NCT00456313
NCT00456313
Withdrawn
Phase 4

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

GlaxoSmithKline1 site in 1 countryDecember 2007

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Withdrawn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

Registry
clinicaltrials.gov
Start Date
December 2007
End Date
December 2007
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

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)

Study Sites (1)

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