Back to resultsNo Resistance After Long Term Treatment SERETIDE
Primary Purpose
Asthma
Status
Withdrawn
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
FLIXOTIDE and SERETIDE
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, fluticasone propionate, salmeterol/fluticasone propionate, combination product, innate immune response, neutrophil priming
Eligibility 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%)
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
arm 1
Arm Description
Outcomes
Primary Outcome Measures
Mean change in neutrophil priming in blood as assessed by marker A17
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00456313
Brief Title
No Resistance After Long Term Treatment SERETIDE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
lack of data
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2007 (Anticipated)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, fluticasone propionate, salmeterol/fluticasone propionate, combination product, innate immune response, neutrophil priming
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
arm 1
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
FLIXOTIDE and SERETIDE
Intervention Description
comparator
Primary Outcome Measure Information:
Title
Mean change in neutrophil priming in blood as assessed by marker A17
Time Frame
on going
Secondary Outcome Measure Information:
Title
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
Time Frame
on going
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Utrecht
ZIP/Postal Code
3582 KE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
No Resistance After Long Term Treatment SERETIDE
We'll reach out to this number within 24 hrs