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
Completed
Completed
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:
Drug: fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI)
Drug: Tiotropium
Enrollment:
260
Observational study model:
Not applicable
Primary completion date:
2012-06-08
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
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
Status
Study Complete
Location
GSK Investigational Site
Cassano Murge (BA), Puglia, Italy, 70020
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000JKR
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1056ABJ
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1424BSF
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
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.
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