Status:
WITHDRAWN
No Resistance After Long Term Treatment SERETIDE
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
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 respons...
Eligibility Criteria
Inclusion
- 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%)
Exclusion
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00456313
Start Date
December 1 2007
End Date
December 1 2007
Last Update
April 17 2015
Active Locations (2)
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1
GSK Investigational Site
Utrecht, Netherlands, 3582 KE
2
GSK Investigational Site
Utrecht, Netherlands, 3584 CX