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

NCT ID: NCT00380133

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2006-04-30

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

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

SB681323

Intervention Type: DRUG

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

Prednisolone

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Tablets matched to SB681323 or prednisolone

Interventions

SB681323

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

Intervention Type: DRUG

Prednisolone

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

Intervention Type: DRUG

Placebo

Tablets matched to SB681323 or prednisolone

Intervention Type: DRUG

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Manchester, Lancashire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 19880675 (View on PubMed)

Other Identifiers

IPI100477

Identifier Type: -

Identifier Source: org_study_id