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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355342
• Other study ID #: SCO40041
• Status: Completed
• Phase: Phase 4
• Start date: April 28, 2004
• Est. completion date: September 6, 2007

Study information

• Verified date: March 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: September 6, 2007
• Est. primary completion date: September 6, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Salmeterol 50 mcg BID
Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.
• Fluticasone Propionate/Salmeterol 250/50 mcg BID
Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening.

Device:
• DISKUS inhaler
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.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Bellingham	Washington
United States	GSK Investigational Site	Berkeley	California
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Bronxville	New York
United States	GSK Investigational Site	Cadillac	Michigan
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Corsicana	Texas
United States	GSK Investigational Site	Fort Collins	Colorado
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fullerton	California
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Hartford	Connecticut
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Kingsport	Tennessee
United States	GSK Investigational Site	Milan	Tennessee
United States	GSK Investigational Site	North Chicago	Illinois
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Rancho Mirage	California
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Saint Charles	Missouri
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Simpsonville	South Carolina
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Tamarac	Florida
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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