Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: July 19, 2006
Last updated: March 1, 2013
Last verified: March 2013

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
Pulmonary Disease, Chronic Obstructive
Chronic Obstructive Pulmonary Disease (COPD)
Drug: fluticasone propionate/salmeterol powder
Drug: salmeterol powder
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:

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
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fluticasone propionate/salmeterol powder Drug: salmeterol powder
    Other Names:
    • fluticasone propionate/salmeterol powder
    • salmeterol powder

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00355342

  Show 32 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00355342     History of Changes
Other Study ID Numbers: SCO40041
Study First Received: July 19, 2006
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Bone Mineral Density
Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bone Diseases
Bone Diseases, Metabolic
Disease Attributes
Musculoskeletal Diseases
Respiratory Tract Diseases
Pathologic Processes
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents processed this record on October 07, 2015