Pulmonary Disease, Chronic ObstructivePhase 2NCT00144859
Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing SB681323 in people with Pulmonary Disease, Chronic Obstructive and Chronic Obstructive Pulmonary Disease (COPD), run by GlaxoSmithKline at 17 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- SB681323
- How many people
- 82 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Jul 2005to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United Kingdom6 sites
GSK Investigational Site
Belfast, BT9 6AB
GSK Investigational Site
Hull, HU16 5JQ
GSK Investigational Site
Leicester, Leicestershire, LE3 9QP
GSK Investigational Site
Liverpool, Lancashire, L9 7AL
GSK Investigational Site
London, E2 9JX
GSK Investigational Site
Newcastle upon Tyne, Northumberland, NE7 7DN
Germany4 sites
GSK Investigational Site
Gauting, Bavaria, 82131
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20535
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
Netherlands4 sites
GSK Investigational Site
Dordrecht, 3317 NM
GSK Investigational Site
Eindhoven, 5623 EJ
GSK Investigational Site
Maastricht, 6229 HX
GSK Investigational Site
Rotterdam, 3000 DR
Denmark2 sites
GSK Investigational Site
Aalborg, DK-9100
GSK Investigational Site
København NV, 2400
About this study
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.
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).
- Being tested
- SB681323
- Keywords
- P38 map kinase, CRP, COPD, safety
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB681323Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)
Secondary outcomes (1)
Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 82 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144859
- Sponsor's protocol ID
- MKC101614
- Status last verified
- Mar 2011
- First submitted
- 1 Sep 2005
- Last updated
- 4 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00144859
- Acronym / sponsor ID
- MKC101614
- Keywords
- P38 map kinase, CRP, COPD, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB681323 | Drug | – |
Primary outcome
Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)
1 secondary outcome
Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB681323 in people with Pulmonary Disease, Chronic Obstructive and Chronic Obstructive Pulmonary Disease (COPD), run by GlaxoSmithKline at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom, Germany, Netherlands, Denmark, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2012.