Last updated: 11/04/2018 11:07:47
No Resistance After Long Term Treatment SERETIDE
GSK study ID
SAM109352
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change in neutrophil priming in blood as assessed by marker A17
Timeframe: 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
Timeframe: on going
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, salmeterol
Collaborators
Not applicable
Study date(s)
October 2007 to December 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
No
- Inclusion:
- Positive skin prick test
Inclusion and exclusion criteria
Inclusion 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%)
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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