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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662805
• Other study ID #: 104246
• Secondary ID: Seretide-pv/GR
• Status: Completed
• Phase: N/A
• First received: April 14, 2008
• Last updated: January 16, 2014
• Start date: June 2004
• Est. completion date: September 2008

Study information

• Verified date: January 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 762
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Trough FEV1, FVC and FEV1/ FVC ratio		every 26 weeks	No
Secondary	Health status as determined using the St George's Respiratory Questionnaire (SGRQ)		every 26 weeks	No
Secondary	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	No