Pulmonary Disease, Chronic ObstructivePhase 2NCT00392587
A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)
A Phase 2 study testing GW856553 in people with Pulmonary Disease, Chronic Obstructive and Chronic Obstructive Pulmonary Disease (COPD), run by GlaxoSmithKline at 3 sites in Germany.
Trial summary
The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days. 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?
- GW856553
- How many people
- 30 participants
- Where
- 3 sitesGermany
- Study dates
- Aug 2006to 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
- Women of childbearing potential
- Established history of COPD
- Cigarette smoking history greater than 10 pack years
- FEV1 between 40 and 80% of predicted normal for height, age and sex.
Who cannot join
- Morbidly obese patients (body mass index >40)
- Hospitalisation or treatment for worsening of COPD in past 6 weeks
- History of increased liver function tests
- hypersensitivity to salbutamol or ipratropium bromide
- Blood pressure > 155/95
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
GSK Investigational Site
Berlin, State of Berlin, 14050
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927
GSK Investigational Site
Hanover, Lower Saxony, 30625
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Parallel Study to Assess the Safety, Tolerability,Pharmacodynamics and Steady State Pharmacokinetics of Repeated Doses of GW856553 in Patients With COPD
The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.
- Being tested
- GW856553
- Keywords
- Pharmacodynamics, Pharmacokinetics, Tolerability, 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.
GW856553Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study.
Measured: 14 days
Secondary outcomes (2)
Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing.
Measured: after 7 and 14 days of dosing
Concentration of the drug in the blood after 1, 3, 7, 10 and 14 days of dosing.
Measured: after 1, 3, 7, 10 and 14 days of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 30 participants (actual)
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
- NCT00392587
- Sponsor's protocol ID
- MKI106209
- Status last verified
- Mar 2011
- First submitted
- 24 Oct 2006
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang S, Lukey P, Beerahee M, Hoke F. Population pharmacokinetics of losmapimod in healthy subjects and patients with rheumatoid arthritis and chronic obstructive pulmonary diseases. Clin Pharmacokinet. 2013 Mar;52(3):187-98. doi: 10.1007/s40262-012-0025-6.
PubMed 23254770
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 Randomised, Double-blind, Placebo-controlled Parallel Study to Assess the Safety, Tolerability,Pharmacodynamics and Steady State Pharmacokinetics of Repeated Doses of GW856553 in Patients With COPD
- ClinicalTrials.gov ID
- NCT00392587
- Acronym / sponsor ID
- MKI106209
- Keywords
- Pharmacodynamics, Pharmacokinetics, Tolerability, COPD, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- First posted
- 26 Oct 2006 (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.
The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.
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 (4 listed)
- Women of childbearing potential
- Established history of COPD
- Cigarette smoking history greater than 10 pack years
- FEV1 between 40 and 80% of predicted normal for height, age and sex.
Key exclusion criteria (5 listed)
- Morbidly obese patients (body mass index >40)
- Hospitalisation or treatment for worsening of COPD in past 6 weeks
- History of increased liver function tests
- hypersensitivity to salbutamol or ipratropium bromide
- Blood pressure > 155/95
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 |
|---|---|---|
| GW856553 | Drug | – |
Primary outcome
Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study.
Time frame: 14 days
2 secondary outcomes
Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing.
Time frame: after 7 and 14 days of dosing
Concentration of the drug in the blood after 1, 3, 7, 10 and 14 days of dosing.
Time frame: after 1, 3, 7, 10 and 14 days of dosing
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.
- Derived from this study: PubMed 23254770Yang S, Lukey P, Beerahee M, Hoke F. Population pharmacokinetics of losmapimod in healthy subjects and patients with rheumatoid arthritis and chronic obstructive pulmonary diseases. Clin Pharmacokinet. 2013 Mar;52(3):187-98. doi: 10.1007/s40262-012-0025-6.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW856553 in people with Pulmonary Disease, Chronic Obstructive and Chronic Obstructive Pulmonary Disease (COPD), run by GlaxoSmithKline at 3 sites in Germany.
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 4 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 3 sites in Germany. 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?
Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00392587, which also lists 1 linked publication.
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.