No Resistance After Long Term Treatment SERETIDE

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00456313

Enrollment

Registered

2007-04-04

Start date

2007-12-31

Completion date

2007-12-31

Last updated

2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, fluticasone propionate, salmeterol/fluticasone propionate, combination product, innate immune response, neutrophil priming

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

Interventions

DRUGFLIXOTIDE and SERETIDE

comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean change in neutrophil priming in blood as assessed by marker A17	on going

Secondary

Measure	Time frame
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026