Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00662805
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : January 20, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Salmeterol/Fluticasone propionate

Study Type : Observational
Actual Enrollment : 762 participants
Time Perspective: Prospective
Official Title: A 2-year Observational Study to Evaluate Safety of Seretide 50/500μg Twice Daily Administered by DISKUS, in Patients With COPD
Study Start Date : June 2004
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
U.S. FDA Resources

Group/Cohort Intervention/treatment
Salmeterol/Fluticasone propionate (50/500 μg)
Open label, 6 visits, single arm study
Drug: Salmeterol/Fluticasone propionate
Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI)

Primary Outcome Measures :
  1. The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria) [ Time Frame: 104 weeks ]
    Evaluate adverse events, vital sign reporting, and concomitant medications

Secondary Outcome Measures :
  1. Trough FEV1, FVC and FEV1/ FVC ratio [ Time Frame: every 26 weeks ]
  2. Health status as determined using the St George's Respiratory Questionnaire (SGRQ) [ Time Frame: every 26 weeks ]
  3. Laboratory assessment including levels of appropriate cardiovascular markers (e.g. CRP, Fibrinogen, PAI-1) and established risk factors, as well as detection of microalbuminuria [ Time Frame: every 26 weeks ]

Biospecimen Retention:   Samples Without DNA
Participants will undergo physical examination and blood pressure measurement. A complete medical history will be taken, as well as blood and urine samples.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Planned: 1000 / Recruited: 771 / Analyzed: 771 A target enrolment of approximately 1000 subjects is planned, at outpatient sites. Any subject with COPD who has an indication to receive Salmeterol + Fluticasone 50/500mcg twice daily at the discretion of the investigator and has met all the inclusion criteria, may take part in the study.

Inclusion criteria

  • Outpatient diagnosed with COPD (Criteria of the British Thoracic Society or NHLBI/WHO Global initiative for Chronic Obstructive Lung Disease)
  • FEV1 < 50% of the one predicted at treatment start and/or
  • History of repetitive COPD exacerbations and/or
  • Patient remains symptomatic despite regular bronchodilator therapy

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00662805

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00662805     History of Changes
Other Study ID Numbers: 104246
Seretide-pv/GR ( Other Identifier: GlaxoSmithKline )
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: January 2014

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists