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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00662805
First received: April 14, 2008
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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 Intervention
Pulmonary Disease, Chronic Obstructive
Drug: Salmeterol/Fluticasone propionate

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria) [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    Evaluate adverse events, vital sign reporting, and concomitant medications


Secondary Outcome Measures:
  • Trough FEV1, FVC and FEV1/ FVC ratio [ Time Frame: every 26 weeks ] [ Designated as safety issue: No ]
  • Health status as determined using the St George's Respiratory Questionnaire (SGRQ) [ Time Frame: every 26 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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.


Enrollment: 762
Study Start Date: June 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Genders Eligible for Study:   Both
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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662805

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00662805     History of Changes
Other Study ID Numbers: 104246, Seretide-pv/GR
Study First Received: April 14, 2008
Last Updated: January 16, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by GlaxoSmithKline:
pharmacovigilance
COPD

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Fluticasone
Salmeterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 22, 2014