No Resistance After Long Term Treatment SERETIDE

This study has been terminated.
(lack of data)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00456313
First received: April 3, 2007
Last updated: March 20, 2009
Last verified: March 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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
Active Comparator: arm 1 Drug: FLIXOTIDE and SERETIDE
comparator
Other Name: FLIXOTIDE and SERETIDE

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00456313     History of Changes
Other Study ID Numbers: SAM109352
Study First Received: April 3, 2007
Last Updated: March 20, 2009
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:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014