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)

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GSK study ID
112355
See study documents
Clinicaltrials.gov ID
NCT00857766
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2010-03-03
    Observational study model:
    Not applicable
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Gaffney, South Carolina, United States, 29340
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Spartanburg, South Carolina, United States, 29303
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Torrance, California, United States, 90505
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hartford, Connecticut, United States, 06105
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35294
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Downington, Pennsylvania, United States, 19335
    Status
    Study Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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