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.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pharmacodynamic effect of single, oral doses of SB-681323 and prednisolone
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Randomised, double-blind, five-way crossover
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.
Intervention: SB681323 (Drug)
Randomised, double-blind, five-way crossover
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.
Intervention: Prednisolone (Drug)
Randomised, double-blind, five-way crossover
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Pharmacodynamic effect of single, oral doses of SB-681323 and prednisolone
Time Frame: 20 weeks
Levels of ex-vivo LPS induced TNFα in whole blood at 1, 2, 6 and 24 hrs post-dose
Secondary Outcomes
- Level of pHSP27 and mRNAs encoding inflammatory markers(20 weeks)
- CD11b and CD62L surface expression on neutrophils(20 weeks)
- Blood concentration of inflammatory markers(20 weeks)
- CRP levels(20 weeks)
- Safety and tolerability of dinsgle doses of SB681323 and prednisolone(20 weeks)
- Exploratory objective #1(20 weeks)
- Exploratory objective #2(20 weeks)