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

Study Overview
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Brief Summary
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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).

Official Title
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A Randomized, Double-Blind, Parallel-Group Clinical Trial Evaluating the Effect of the Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Twice Daily Via DISKUS® Inhaler Versus Salmeterol 50mcg Twice Daily Via DISKUS® Inhaler on Bone Mineral Density in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Salmeterol 50 mcg BID
* Drug: Fluticasone Propionate/Salmeterol 250/50 mcg BID
* Device: DISKUS inhaler


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salmeterol 50 mcg BID<br>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. | Drug: Salmeterol 50 mcg BID<br>* Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.<br>* Other names: GR33343G;Device: DISKUS inhaler<br>* Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.<br>|
| Experimental: Fluticasone Propionate/Salmeterol 250/50 mcg BID<br>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. | Drug: Fluticasone Propionate/Salmeterol 250/50 mcg BID<br>* Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.<br>* Other names: CCI18781/GR33343G;Device: DISKUS inhaler<br>* Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4 | BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms). BMD at the lumber spine (L1-L4) was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on Day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value. | Baseline and Week 26, 52, 78, 104, 130, and 156 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in BMD at the Total Hip | BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms).BMD at the total hip was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value. | Baseline and Week 26, 52, 78, 104, 130, and 156 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Bone Mineral Density, Osteopenia, Chronic Obstructive Pulmonary Disease, COPD