Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00355342

Purpose

This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits will include lung function tests and scans of your bones. The purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with Chronic Obstructive Pulmonary Disease (COPD).

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD) Osteoporosis Osteopenia	Drug: fluticasone propionate/salmeterol powder Drug: salmeterol powder	Phase IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Minerals Osteoporosis

Drug Information available for: Fluticasone Fluticasone propionate Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
Official Title:	A Randomized, Double-Blind, Parallel-Group Clinical Trial Evaluating the Effect of the Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID Via DISKUS Versus Salmeterol 50mcg BID Via DISKUS on Bone Mineral Density in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Bone mineral density measured at the lumbar spine.

Secondary Outcome Measures:

Bone mineral density measured at the total hip.

Estimated Enrollment:	180
Study Start Date:	April 2004

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Established clinical history of COPD.
Baseline FEV1 <70% predicted normal, and FEV1/FVC ratio of less than 70%.
Smoking history of at least 10 pack-years, where both current and former smokers will be eligible.
Must have at least one native, evaluable hip.

Exclusion criteria:

History of or evidence for metabolic bone diseases other than osteoporosis or osteopenia.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355342

Show 32 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SCO40041
Study First Received:	July 19, 2006
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00355342
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Chronic Obstructive Pulmonary Disease
COPD
Osteoporosis
Osteopenia
Bone Mineral Density

Study placed in the following topic categories:

Lung Diseases, Obstructive
Salmeterol
Musculoskeletal Diseases
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Fluticasone
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Anti-Allergic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009