Overview

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

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Salmeterol Xinafoate
Xhance
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.