Last updated: 07/14/2020 15:00:25
Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 28-day, randomised, double-blind, placebo-controlled study to assess the safety, tolerability, anti-inflammatory effect and steady-state pharmacokinetics of SB-681323 7.5 mg per day in patients with chronic obstructive pulmonary disease.
Trial description: This is a 28-day, placebo controlled clinical study assessing the safety, tolerability anti-inflammatory effect and pharmacokinetics of SB681323 in patients with COPD (Chronic Obstructive Pulmonary Disease).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)
Timeframe: 8 Weeks
Secondary outcomes:
Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics
Timeframe: 8 Weeks
Interventions:
Drug: SB681323
Enrollment:
82
Observational study model:
Not applicable
Primary completion date:
2006-02-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
dilmapimod
Collaborators
Not applicable
Study date(s)
July 2005 to March 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
40 - 75 years
Accepts healthy volunteers
No
- Non-childbearing potential.
- Clinical diagnosis of COPD.
- Current diagnosis of asthma.
- Active tuberculosis, sarcoidosis or bronchiectasis.
Inclusion and exclusion criteria
Inclusion criteria:
- Non-childbearing potential.
- Clinical diagnosis of COPD.
- Cigarette smoking history of greater than or equal to 10 pack years.
- Post-bronchodilator FEV1 to FVC ratio (FEV1:FVC) < 0.7
- Post-bronchodilator FEV1 50%
- 80% of predicted normal.
- Receiving inhaled corticosteroids for a minimum of 6 weeks prior to Screening.
- Serum CRP concentration greater than 3mg/L.
Exclusion criteria:
- Current diagnosis of asthma.
- Active tuberculosis, sarcoidosis or bronchiectasis.
- History of any type of malignancy, rheumatoid arthritis or other conditions associated with chronic inflammation.
- Clinically significant renal or hepatic disease.
- History of increased liver function tests, or patients receiving hormone replacement therapy, statins or systemic or topical corticosteroids.
Trial location(s)
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE3 9QP
Status
Study Complete
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Liverpool, Lancashire, United Kingdom, L9 7AL
Status
Study Complete
Location
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom, NE7 7DN
Status
Study Complete
Location
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE3 9Q
Status
Study Complete
Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9L
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom, NE7 7D
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2006-02-03
Actual study completion date
2006-02-03
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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