No Resistance After Long Term Treatment SERETIDE - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00456313

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: FLIXOTIDE and SERETIDE	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Advair

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Mean change in neutrophil priming in blood as assessed by marker A17 [ Time Frame: on going ]

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 [ Time Frame: on going ]

Enrollment:	0
Study Start Date:	December 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
arm 1: Active Comparator	Drug: FLIXOTIDE and SERETIDE comparator

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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%)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456313

Locations

Netherlands
GSK Investigational Site
UTRECHT, Netherlands, 3582 KE
GSK Investigational Site
UTRECHT, Netherlands, 3584 CX

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SAM109352
Study First Received:	April 3, 2007
Last Updated:	March 20, 2009
ClinicalTrials.gov Identifier:	NCT00456313 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:

asthma
fluticasone propionate
salmeterol/fluticasone propionate

combination product
innate immune response
neutrophil priming

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010