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
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
- 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
- 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
Inclusion and exclusion 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
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9LT
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
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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