Last updated: 11/04/2018 08:25:01

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

GSK study ID
IPI100477
Clinicaltrials.gov ID
NCT00380133
EudraCT ID
2005-000076-40
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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 description: This study will assess the effects of single oral doses of SB681323 and prednisolone on biomarkers in induced sputum and blood COPD patients
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: 20 weeks

Secondary outcomes:

Level of pHSP27 and mRNAs encoding inflammatory markers

Timeframe: 20 weeks

CD11b and CD62L surface expression on neutrophils

Timeframe: 20 weeks

Blood concentration of inflammatory markers

Timeframe: 20 weeks

CRP levels

Timeframe: 20 weeks

Safety and tolerability of dinsgle doses of SB681323 and prednisolone

Timeframe: 20 weeks

Exploratory objective #1

Timeframe: 20 weeks

Exploratory objective #2

Timeframe: 20 weeks

Interventions:
  • Drug: SB681323
  • Drug: Prednisolone
  • Drug: Placebo
    • Enrollment:
    20
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    dilmapimod
    Collaborators
    Not applicable
    Study date(s)
    June 2005 to April 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    40 - 75 years
    Accepts healthy volunteers
    No
    • 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).
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Manchester, Lancashire, United Kingdom, M23 9LT
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-05-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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