No Resistance After Long Term Treatment SERETIDE

April 15, 2015 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • GSK Investigational Site
      • Utrecht, Netherlands, 3582 KE
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: arm 1
Drug: FLIXOTIDE and SERETIDE
comparator

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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
Time Frame: on going
on going

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Anticipated)

December 1, 2007

Study Completion (Anticipated)

December 1, 2007

Study Registration Dates

First Submitted

April 3, 2007

First Submitted That Met QC Criteria

April 3, 2007

First Posted (Estimate)

April 4, 2007

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAM109352

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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