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...
Date First Received: April 14, 2008
Last Updated: April 16, 2008
Verified by: GlaxoSmithKline, April 2008
Clinical Trial Phase: Phase 4 | Start Date: June 2004
Overall Status: Active, not recruiting
Estimated Enrollment: 1000
Brief Summary
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”
Condition Keyword(s):
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.
Study Type: Observational
Study Design: Prospective
Study Primary Completion Date: September 2008
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00662805
Study ID Number: 104246
ClinicalTrials.gov Identifier: NCT00662805
Health Authority: Greece: National Organization of Medicines
Clinical Trials Authorship and Review
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