Pharmacovigilance Study To Evaluate Safety Of SERETIDE Administration In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: A Pharmacovigilance Study to Evaluate Safety of Seretide 50/500µg Administered Twice Daily Through the Discus Device, for 104 Weeks, to Subjects With COPD
Study design: Prospective
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject should fulfill criteria for the subscription of SERETIDE as these are
mentioned in SPC.
Exclusion Criteria:
- Subject should not enter the study if he has a known hypersensitivity to any of the
SERETIDE ingredients
- Is a pregnant or or lactating woman, or a woman who plans to be pregnant
- Suffers from a serious disease which is not satisfactorily controlled/treated or,
according to investigator´s judgment will intervene with subject compliance with the
protocol
Locations and Contacts
GSK Clinical Trials call center, Athens 115 26, Greece
GSK Clinical Trials call center, Patras 26500, Greece
GSK Clinical Trials call center, Athens 155 62, Greece
Additional Information
Starting date: June 2004
Ending date: September 2008
Last updated: April 16, 2008
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