Last updated: 11/07/2018 04:47:13
A 16-Week Study to Evaluate the Effect of Advair DISKUS™ 250/50mcg on Arterial Stiffness in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, Parallel-Group, 16-Week Study to Evaluate the Effect of Fluticasone Propionate/Salmeterol DISKUS® 250/50mcg BID and Placebo on Arterial Stiffness in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The purpose of this study is to evaluate in patients with Chronic Obstructive Pulmonary Disease (COPD) if Advair DISKUS™ 250/50mcg BID modifies arterial stiffness which is a measure associated with risk of heart disease.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean Change From Baseline in Aortic Pulse Wave Velocity (aPWV) at the 12-Week Endpoint
Timeframe: Baseline and the 12-Week Endpoint (up to Week 12)
Secondary outcomes:
Mean Change From Baseline in Augmentation Index (AIx) at the 12-Week Endpoint
Timeframe: Baseline and the 12-Week Endpoint (up to Week 12)
Mean Change from Baseline in Forced Expiratory Volume in One Second (FEV1) at the 12-Week Endpoint
Timeframe: Baseline and the 12-Week Endpoint (up to Week 12)
Interventions:
Drug: ADVAIR DISKUS™ 250/50mcg
Other: Placebo
Enrollment:
249
Observational study model:
Not applicable
Primary completion date:
2010-03-03
Time perspective:
Not applicable
Clinical publications:
Dransfield MT, Cockcroft JR, Townsend RR, Coxson HO, Sharma SS, Rubin DB, Emmett AH, Cicale MJ, Crater GD, Martinez FJ. Effect of fluticasone propionate/salmeterol on arterial stiffness in patients with COPD. Respir Med. 2011 Sep;105(9):1322-30
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
GSK
Study date(s)
March 2009 to March 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
No
- Signed and dated written informed consent obtained from the subject and/or subject’s legally acceptable representative prior to study participation.
- Males or females greater then or equal to 50 years of age.
- A current diagnosis of asthma
- A body mass index (BMI) of > or equal to 35kg/m2
Inclusion and exclusion criteria
Inclusion criteria:
- Signed and dated written informed consent obtained from the subject and/or subject’s legally acceptable representative prior to study participation.
- Males or females greater then or equal to 50 years of age.
- A post-albuterol FEV1/FVC ratio of < or equal to 0.70
- A post-albuterol FEV1 < 80% of predicted normal.
- Patients can be current or fomer smoker and must have a cigarette smoking history of > greater then or equal to 10 pack-years .
Exclusion criteria:
- A current diagnosis of asthma
- A body mass index (BMI) of > or equal to 35kg/m2
- A respiratory diagnosis other than COPD (e.g., lung cancer, bronchiectasis, sarcoidosis, tuberculosis, lung fibrosis).
Trial location(s)
Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90505
Status
Study Complete
Location
GSK Investigational Site
Hartford, Connecticut, United States, 06105
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
Downington, Pennsylvania, United States, 19335
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55407
Status
Study Complete
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Morgantown, West Virginia, United States, 26505
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Chesterfield, Missouri, United States, 63017
Status
Study Complete
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37601
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103-8415
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85006
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-03-03
Actual study completion date
2010-03-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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