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

NCT00662805 | Completed

• 2 other identifiers: 104246Seretide-pv/GR
• Study Type: observational
• Target: 762
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

pharmacovigilance; COPD

Outcome Measures

Primary Outcomes (1)

• The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria)

  Evaluate adverse events, vital sign reporting, and concomitant medications

  104 weeks

Secondary Outcomes (3)

• Trough FEV1, FVC and FEV1/ FVC ratio

  every 26 weeks

• Health status as determined using the St George's Respiratory Questionnaire (SGRQ)

  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

  every 26 weeks

Study Arms (1)

Salmeterol/Fluticasone propionate (50/500 μg)

Open label, 6 visits, single arm study

Drug: Salmeterol/Fluticasone propionate

Interventions

Salmeterol/Fluticasone propionate DRUG

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

Salmeterol/Fluticasone propionate (50/500 μg)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Subject should fulfill criteria for the subscription of SERETIDE as these are mentioned in SPC.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 21, 2008
• Study Start: June 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 20, 2014

Record last verified: 2014-01