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
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:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Salmeterol
Fluticasone
Fluticasone, salmeterol drug combination
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on April 23, 2014