Pharmacovigilance Study To Evaluate Safety Of SERETIDE Administration In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study is ongoing, but not recruiting participants.

First Received: April 14, 2008 Last Updated: October 13, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00662805

Purpose

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.

Condition
Chronic Obstructive Pulmonary Disease (COPD)

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
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

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	1000
Study Start Date:	June 2004
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662805

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104246, Seretide-pv/GR
Study First Received:	April 14, 2008
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00662805 History of Changes
Health Authority:	Greece: National Organization of Medicines

Keywords provided by GlaxoSmithKline:

COPD
pharmacovigilance

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009