Phase 3
Completed N=279
A Study to Compare the Impact of Fulticasone Furoate/Vilanterol vs. Tiotropium on Arterial Stiffness in COPD
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01395888 ↗
Enrolled (actual)
279
Serious AEs
5.8%
Results posted
Aug 2013
Primary outcomePrimary: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84) — -0.859; -1.118 meters per second (m/sec) — p=0.484
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84) |
-0.859; -1.118 | 0.484 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01395888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.