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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2008 by GlaxoSmithKline. Recruitment status was Active, not recruiting

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

Sponsor:	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)

Study Type:	Observational
Study Design:	Time Perspective: 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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

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

Keywords provided by GlaxoSmithKline:

COPD
pharmacovigilance

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Fluticasone, salmeterol drug combination
Glucocorticoids

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012