Last updated: 11/07/2018 09:02:14
A study to compare the Impact of fulticasone furoate/vilanterol vs. Tiotropium on arterial stiffness in COPD
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 12 week study to evaluate the effect of fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler (NDPI) on arterial stiffness compared with Tiotropium bromide 18 mcg delivered once daily via a HandiHaler in subjects with chronic obstructive pulmonary disease (COPD).
Trial description: This study is designed to evaluate the effect of fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) Inhalation Powder once daily (QD) on arterial stiffness compared with Tiotropium QD over 12 week treatment period in subjects with COPD and aortic pulse wave velocity (aPWV) > 12.0 m/s at Visit 1. Arterial stiffness will be measured as aPWV. This is a comparator, randomised, double-blind, double-dummy, parallel group, multi-centre study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be an approximate 7-day Follow-up period after the treatment period.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the end of the 12-week Treatment Period (Day 84)
Timeframe: Baseline to Day 84 (Early Withdrawal)
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
260
Primary completion date:
2012-06-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Pepin JL, Cockcroft JR, Midwinter D, Sharma S, Rubin DB, Andreas S.Long-acting bronchodilators and arterial stiffness in patients with COPD: a comparison of fluticasone furoate/vilanterol with tiotropium.Chest.2014;146(6):1521-530doi: 10.1378/chest.13-2859
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, tiotropium bromide, vilanterol
Collaborators
Not applicable
Study date(s)
June 2011 to August 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- Type of subject: Outpatient
- Informed consent: Subjects must give their signed and dated written informed consent to participate.
- Body Mass Index of less then or equal to 35
Inclusion and exclusion criteria
Inclusion criteria:
- Type of subject: Outpatient
- Informed consent: Subjects must give their signed and dated written informed consent to participate. -Gender: Male or female subjects. -Age: greater then or equal to 40 years of age at Screening (Visit 1) -COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society (ATS) /European Respiratory Society(ERS). -Subjects with a current or prior history ofgreater then or equal to 10 pack-years of cigarette smoking at Screening (Visit 1). -Subjects with a measured post-albuterol/salbutamol FEV1 less then 70% of predicted at Screening (Visit 1). -Subjects with a measured post-albuterol/salbutamol FEV1/FVC ratio of less then or equal to 0.70 at Screening (Visit 1). -Exacerbation History: Subjects who have been hospitalised or have been treated with oral corticosteroids or antibiotics for their COPD within the last 3 years prior to Screening (V1). -Baseline aPWV: subjects with a measured aPWV greater then 12.0 m/s at Screening (Visit 1).
Exclusion criteria:
- Body Mass Index of less then or equal to 35
Trial location(s)
Location
GSK Investigational Site
Vladivostok, Primorskiy Kray, Russia, 690022
Status
Study Complete
Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
Showing 1 - 6 of 54 Results
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
Study complete
Actual primary completion date
2012-06-08
Actual study completion date
2012-06-08
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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