Study of SB681323 and Prednisolone on Biomarkers in COPD (Chronic Obstructive Pulmonary Disease) Patients

Phase 1

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: SB681323; Drug: Prednisolone; Drug: Placebo

• Registration Number: NCT00380133
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will assess the effects of single oral doses of SB681323 and prednisolone on biomarkers in induced sputum and blood COPD patients

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2006-09-21
• Study First Submitted QC: 2006-09-21
• Study First Posted: 2006-09-25
• Status Verified: 2012-03
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Randomised, double-blind, five-way crossover	SB681323	A randomised, double-blind, double-dummy, placebo-controlled, five-way crossover study to assess the effects of single oral doses of SB-681323 (7.5 mg and 25 mg) and prednisolone (10 mg and 30 mg) on biomarkers in induced sputum and blood in COPD patients.
Randomised, double-blind, five-way crossover	Placebo	A randomised, double-blind, double-dummy, placebo-controlled, five-way crossover study to assess the effects of single oral doses of SB-681323 (7.5 mg and 25 mg) and prednisolone (10 mg and 30 mg) on biomarkers in induced sputum and blood in COPD patients.
Randomised, double-blind, five-way crossover	Prednisolone	A randomised, double-blind, double-dummy, placebo-controlled, five-way crossover study to assess the effects of single oral doses of SB-681323 (7.5 mg and 25 mg) and prednisolone (10 mg and 30 mg) on biomarkers in induced sputum and blood in COPD patients.

Primary Outcome Measures

Name	Time	Method
Pharmacodynamic effect of single, oral doses of SB-681323 and prednisolone	20 weeks	Levels of ex-vivo LPS induced TNFα in whole blood at 1, 2, 6 and 24 hrs post-dose

Secondary Outcome Measures

Name	Time	Method
Level of pHSP27 and mRNAs encoding inflammatory markers	20 weeks	Levels obtained in sputum and whole blood samples
CD11b and CD62L surface expression on neutrophils	20 weeks	Levels obtained in whole blood samples
Blood concentration of inflammatory markers	20 weeks	GSK's COPD multiplex biomarker assay
CRP levels	20 weeks	Levels obtained in COPD patient sera
Safety and tolerability of dinsgle doses of SB681323 and prednisolone	20 weeks	Vitals, AEs, ECGs, safety laboratory, pulmonary function FEV1 and FVC
Exploratory objective #1	20 weeks	Transcriptomic profiles of induced sputum cells and whole blood Exploratory micro-array analysis of mRNA biomarkers in induced sputum samples at 2 hrs post-dose and whole blood samples at baseline (pre-dose), and 6 hrs post-dose (earlier post-dose blood samples (1 and 2 hrs ) may also be examined)
Exploratory objective #2	20 weeks	Exploratory analysis of inflammatory biomarker concentrations in induced sputum supernatants (e.g. myeloperoxidase, IL-6, TNF-α, total protein) at 2 hours post-dose

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Manchester, Lancashire, United Kingdom