| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01395888 | A Study to Compare the Impact of Fulticasone Furoate/Vilanterol vs. Tiotropium on Arterial Stiffness in COPD | PHASE3 | COMPLETED | 260 | — | — | Jun 30, 2011 | Aug 6, 2012 | Feb 15, 2018 | 55 | Argentina, France +5 |
| NCT00950807 | GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease | PHASE2 | COMPLETED | 176 | — | — | Sep 1, 2009 | Mar 15, 2010 | Nov 8, 2017 | 19 | United States, Germany |
| NCT00325169 | SERETIDE Plus Tiotropium Versus Individual Components | PHASE2 | COMPLETED | 41 | — | — | Dec 1, 2005 | Aug 1, 2006 | Oct 21, 2016 | 5 | Belgium, United Kingdom |
PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of Eh/2pR, where E is Young's modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and p is the blood density. Change from Baseline was calculated as the Day 84 value minus the Baseline value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking status at screening, geographical region, Baseline aPWV, and interaction terms of Baseline by visit and treatment by visit.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis were performed using a mixed model with covariates of mean Baseline, period Baseline, treatment and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.
| Arm | Type | Description |
|---|---|---|
| Relovair | EXPERIMENTAL | Inhaled long-acting bronchodilator and corticosteroid combination |
| Tiotropium | ACTIVE_COMPARATOR | Inhaled long-acting anticholinergic |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Arm 1 | EXPERIMENTAL | GSK573719 1000mcg once daily |
| Arm 2 | EXPERIMENTAL | GSK573719 500mcg once daily |
| Arm 3 | EXPERIMENTAL | GSK573719 250mcg once daily |
| Arm 4 | EXPERIMENTAL | GSK573719 125mcg once daily |
| Arm 5 | EXPERIMENTAL | GSK573719 62.5 mcg once daily |
| Arm 6 | EXPERIMENTAL | GSK573719 250mcg twice daily |
| Arm 7 | EXPERIMENTAL | GSK573719 125mcg twice daily |
| Arm 8 | EXPERIMENTAL | GSK573719 62.5mcg twice daily |
| Name | Type | Description |
|---|---|---|
| fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI) | DRUG | fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler (NDPI) |
| Tiotropium | DRUG | • Tiotropium (18 mcg) administered QD via a HandiHaler |
| Placebo | DRUG | Inactive/ excipients only |
| GSK573179 | DRUG | GSK573179 investigational drug |
| Tiotropium + SERETIDE 50/500 | DRUG | - |
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 clinic...