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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salmeterol/fluticasone propionate

Drug

Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI)

Primary outcomes

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 outcomes

Trough FEV1, FVC and FEV1/ FVC ratio

Time frame: every 26 weeks
Health status as determined using the St George's Respiratory Questionnaire (SGRQ)

Time frame: 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

Time frame: every 26 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A 2-year Observational Study to Evaluate Safety of Seretide 50/500μg Twice Daily Administered by DISKUS, in Patients With COPD

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Apr 21, 2008
Registry last updated: Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed