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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00355342
First Posted: July 21, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
July 19, 2006
July 21, 2006
October 12, 2017
April 2004
September 2007   (Final data collection date for primary outcome measure)
Bone mineral density measured at the lumbar spine.
Same as current
Complete list of historical versions of study NCT00355342 on ClinicalTrials.gov Archive Site
Bone mineral density measured at the total hip.
Same as current
Not Provided
Not Provided
 
Bone Mineral Density Study In Patients With Chronic Obstructive Pulmonary Disease. DISKUS® Inhaler is a Trademark of the GSK Group of Companies.
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)
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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: fluticasone propionate/salmeterol powder
  • Drug: salmeterol powder
    Other Name: fluticasone propionate/salmeterol powder
Experimental: Arm 1
Interventions:
  • Drug: fluticasone propionate/salmeterol powder
  • Drug: salmeterol powder
This study has not been published in the scientific literature.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
September 2007
September 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00355342
SCO40041
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP