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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Salmeterol 50 mcg BID; Device: DISKUS inhaler; Drug: Fluticasone Propionate/Salmeterol 250/50 mcg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT00355342

SCO40041

Details and patient eligibility

About

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).

Enrollment: 186 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 2 patient groups

Salmeterol 50 mcg BID

Experimental group

Description:

Participants randomized to this arm received salmeterol 50 microgram (mcg), formulated with lactose via the DISKUS™ inhaler one inhalation twice daily (BID) one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. DISCUS is registered trademark product of GlaxoSmithKline.

Treatment:

Drug: Salmeterol 50 mcg BID

Device: DISKUS inhaler

Fluticasone Propionate/Salmeterol 250/50 mcg BID

Experimental group

Description:

Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.

Treatment:

Drug: Fluticasone Propionate/Salmeterol 250/50 mcg BID

Device: DISKUS inhaler