No Resistance After Long Term Treatment SERETIDE

NCT00456313 | Withdrawn Phase 4

• 1 other identifier: SAM109352
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Conditions

Asthma

Keywords

asthma; fluticasone propionate; salmeterol/fluticasone propionate; combination product; innate immune response; neutrophil priming

Outcome Measures

Primary Outcomes (1)

• Mean change in neutrophil priming in blood as assessed by marker A17

  on going

Secondary Outcomes (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

  on going

Study Arms (1)

arm 1

ACTIVE COMPARATOR

Drug: FLIXOTIDE and SERETIDE

Interventions

FLIXOTIDE and SERETIDE DRUG

comparator

arm 1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• FEV1 % predicted \> 70%
• ACT score \< 25 after run-in period

You may not qualify if:

• 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
• Non-compliance (\< 70%)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Utrecht, 3582 KE, Netherlands

Location

GSK Investigational Site

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 4, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

NL (2)