No Resistance After Long Term Treatment SERETIDE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00456313
Recruitment Status : Withdrawn (lack of data)
First Posted : April 4, 2007
Last Update Posted : April 17, 2015
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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

Condition or disease Intervention/treatment Phase
Asthma Drug: FLIXOTIDE and SERETIDE Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2007
Estimated Primary Completion Date : December 2007
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: arm 1 Drug: FLIXOTIDE and SERETIDE

Primary Outcome Measures :
  1. Mean change in neutrophil priming in blood as assessed by marker A17 [ Time Frame: on going ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00456313

GSK Investigational Site
Utrecht, Netherlands, 3582 KE
GSK Investigational Site
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00456313     History of Changes
Other Study ID Numbers: SAM109352
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Keywords provided by GlaxoSmithKline:
fluticasone propionate
salmeterol/fluticasone propionate
combination product
innate immune response
neutrophil priming

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists