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
NCT00662805
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    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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