Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.

• Status: Completed
• Trial end date: 2007-09-06
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Salmeterol Xinafoate; Xhance

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.