Last updated: 11/04/2018 09:15:34
A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: 14 days
Secondary outcomes:
Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing.
Timeframe: after 7 and 14 days of dosing
Concentration of the drug in the blood after 1, 3, 7, 10 and 14 days of dosing.
Timeframe: after 1, 3, 7, 10 and 14 days of dosing
Interventions:
Drug: GW856553
Enrollment:
30
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
losmapimod
Collaborators
Not applicable
Study date(s)
August 2006 to December 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
40 - 75 years
Accepts healthy volunteers
No
- Women of childbearing potential
- Established history of COPD
- Morbidly obese patients (body mass index >40)
- Hospitalisation or treatment for worsening of COPD in past 6 weeks
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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 location(s)
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
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
Not applicable
Actual study completion date
2006-20-12
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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