Last updated: 11/03/2018 00:31:57
Pharmacovigilance study to evaluate safety of SERETIDE in participants with Chronic Obstructive Pulmonary Disease (COPD)
GSK study ID
104246
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A 2-year Observational study to evaluate safety of Seretide 50/500μg twice daily administered by DISKUS, in patients with COPD
Trial description: Primary objective: Evaluation of the safety of Seretide discus administration in subjects with COPD. Treatment duration: 2 years. Study has 3 phases: Screening phase (visit 1), treatment phase (visits 2-5. In the case of AE, there will be another visit (visit 6) as a follow up visit - follow up phase.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria)
Timeframe: 104 weeks
Secondary outcomes:
Trough FEV1, FVC and FEV1/ FVC ratio
Timeframe: every 26 weeks
Health status as determined using the St George’s Respiratory Questionnaire (SGRQ)
Timeframe: every 26 weeks
Laboratory assessment including levels of appropriate cardiovascular markers (e.g. CRP, Fibrinogen, PAI-1) and established risk factors, as well as detection of microalbuminuria
Timeframe: every 26 weeks
Interventions:
Drug: Salmeterol/Fluticasone propionate
Enrollment:
762
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
June 2004 to December 2008
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Subject should fulfill criteria for the subscription of SERETIDE as these are mentioned in SPC.
- Hypersensitivity to Salmeterol + Fluticasone or any of its excipients
- Pregnancy, lactation or scheduled pregnancy during the observational period of the study
Inclusion and exclusion criteria
Inclusion criteria:
- Subject should fulfill criteria for the subscription of SERETIDE as these are mentioned in SPC.
Exclusion criteria:
- Hypersensitivity to Salmeterol + Fluticasone or any of its excipients
- Pregnancy, lactation or scheduled pregnancy during the observational period of the study
- Serious illness/disease, not adequately controlled, or with a potential to interfere with the patients’ participation in the present study, according to the investigator/physician's judgment.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2008-22-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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