No Resistance After Long Term Treatment SERETIDE

Phase 4

Withdrawn

• Conditions: Asthma
• Interventions: Drug: FLIXOTIDE and SERETIDE

• Registration Number: NCT00456313
• Lead Sponsor: GlaxoSmithKline

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-03
• Study First Submitted QC: 2007-04-03
• Study First Posted: 2007-04-04
• Study Start: 2007-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm 1	FLIXOTIDE and SERETIDE	-

Primary Outcome Measures

Name	Time	Method
Mean change in neutrophil priming in blood as assessed by marker A17	on going

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇳🇱 Utrecht, Netherlands