Last updated: 11/04/2018 10:23:37
Prednisolone Novel Endpoint Study in Patients with Chronic Obstructive Pulmonary Disease (COPD)
GSK study ID
RES106087
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomized, double-blind study of treatment with a known anti-inflammatory (prednisolone) to evaluate novel endpoints in patients with chronic obstructive pulmonary disease (COPD)
Trial description: Prednisolone will be used as a model medication to identify new clinical outcomes for future evaluation of new therapies in short-term studies (up to 4 weeks) in patients with Chronic Obstructive Pulmonary Disease (COPD).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
90
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
March 2006 to May 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- An established clinical history of COPD
- COPD exacerbation requiring steroid and/or antibiotics in the last month
- Taking oral or inhaled steroids for more than 14 days in the last 6 months
Inclusion and exclusion criteria
Inclusion criteria:
- An established clinical history of COPD
- Evidence of bronchitis
- Current or ex-smoker
Exclusion criteria:
- COPD exacerbation requiring steroid and/or antibiotics in the last month
- Taking oral or inhaled steroids for more than 14 days in the last 6 months
- Unable to withhold salbutamol/albuterol for a 6 hour period
- History of alcohol, substance or drug abuse within the last year.
- Other significant medical condition e.g. diabetes
- Cancer that has not been in complete remission for at least 5 years
- As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.
Trial location(s)
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500691
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-03-05
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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