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CompletedNCT00380133Updated Jun 4, 2012

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

A Phase 1 interventional study of SB681323 and Prednisolone in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-04.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • COPD SB-681323 prednisolone biomarkers
03

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 20 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is current smoker or ex-smoker with a smoking history of at least 10 pack years (number of pack years = [number of cigarettes per day/20] x number of years smoked).
  • The patient has serum CRP ≥ 3 mg/L at screening
  • Subjects able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion criteria

Exclusion criteria:

  • Any clinically relevant abnormality identified on medical assessment, laboratory examination, or 12-lead ECG which in the opinion of the investigator, will lead to an unacceptable increase in the risk of study participation or will call into question the validity of the outcome measures.
  • Subjects who are obese, defined as having a BMI > 40
  • Subject has a diagnosis of asthma that is confirmed by the investigator.
  • Subject has poorly controlled COPD, defined as the occurrence of any of the following in the 2 weeks prior to visit 1: acute worsening of COPD that is managed by the subject at home by self-treatment with corticosteroids or antibiotics, or that requires treatment by a physician.
  • Subject has active tuberculosis, lung cancer or clinically overt bronchiectasis.
  • Symptoms of "cold or flu" or any respiratory infection/symptoms at the start of the study
  • Subject has cardiac, gastrointestinal, neurological, renal, endocrine or psychiatric disease that is uncontrolled on permitted medication
  • Subject has history of allergic rhinitis.
  • Subjects with a history of any type of malignancy with the exception of successfully treated basal cell cancer of the skin.
  • Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease).
  • Subjects with chronic infections such as gingivitis, periodontitis, prostatitis, gastritis, and urinary tract infections.
  • Subjects with history of hepatic disease.
  • History of increased liver function tests (ALT, AST) above upper limit of normal in the past 6 months and/or liver function tests (bilirubin, ALT, AST) above upper limit of normal at screening.
  • History of positive HIV, Hepatitis B /C antibody test result, a positive Hep B/C result at screen or a risk factor for these diseases.
  • History of drug or other allergy, which, in the opinion of the Investigator precludes participation in the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    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.

    Drug: SB681323 · Drug: Prednisolone · Drug: Placebo

Interventions

  • DrugSB681323

    5 mg and 2.5 mg tablets - The tablets will be round (9.0 mm in diameter) and white and provided in labelled bottles

  • DrugPrednisolone

    5 mg size DB AA capsule shell (Swedish orange) with a powder backfill (lactose Anhydrous)

  • DrugPlacebo

    Tablets matched to SB681323 or prednisolone

06

What researchers measure

Primary outcomes

  1. Pharmacodynamic effect of single, oral doses of SB-681323 and prednisolone

    Levels of ex-vivo LPS induced TNFα in whole blood at 1, 2, 6 and 24 hrs post-dose

    Time frame: 20 weeks

Secondary outcomes

  1. Level of pHSP27 and mRNAs encoding inflammatory markers

    Levels obtained in sputum and whole blood samples

    Time frame: 20 weeks

  2. CD11b and CD62L surface expression on neutrophils

    Levels obtained in whole blood samples

    Time frame: 20 weeks

  3. Blood concentration of inflammatory markers

    GSK's COPD multiplex biomarker assay

    Time frame: 20 weeks

  4. CRP levels

    Levels obtained in COPD patient sera

    Time frame: 20 weeks

  5. Safety and tolerability of dinsgle doses of SB681323 and prednisolone

    Vitals, AEs, ECGs, safety laboratory, pulmonary function FEV1 and FVC

    Time frame: 20 weeks

  6. Exploratory objective #1

    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)

    Time frame: 20 weeks

  7. Exploratory objective #2

    Exploratory analysis of inflammatory biomarker concentrations in induced sputum supernatants (e.g. myeloperoxidase, IL-6, TNF-α, total protein) at 2 hours post-dose

    Time frame: 20 weeks

07

Study locations

1 site
  • GSK Investigational Site
    Manchester, Lancashire M23 9LT, United Kingdom
08

References and documents

Publications

  • Singh D, Smyth L, Borrill Z, Sweeney L, Tal-Singer R. A randomized, placebo-controlled study of the effects of the p38 MAPK inhibitor SB-681323 on blood biomarkers of inflammation in COPD patients. J Clin Pharmacol. 2010 Jan;50(1):94-100. doi: 10.1177/0091270009347873. Epub 2009 Oct 30. PubMed 19880675 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2005, a primary completion of Apr 2006 and a completion of Apr 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2006
First posted
Sep 25, 2006
Start
Jun 2005
Primary completionActual
Apr 2006
CompletionActual
Apr 2006
Last update
Jun 4, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00380133
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 25, 2006
Start date
Jun 2005
Primary completion
Apr 2006
Completion
Apr 2006
Last update
Jun 4, 2012

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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