No Resistance After Long Term Treatment SERETIDE

Asthma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00456313
• Other study ID #: SAM109352
• Status: Withdrawn
• Phase: Phase 4
• First received: April 3, 2007
• Last updated: April 15, 2015
• Start date: December 2007
• Est. completion date: December 2007

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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%)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• FLIXOTIDE and SERETIDE
comparator

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Utrecht
Netherlands	GSK Investigational Site	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in neutrophil priming in blood as assessed by marker A17		on going
Secondary	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