A Study to Compare the Impact of Fulticasone Furoate/Vilanterol vs. Tiotropium on Arterial Stiffness in COPD

NCT01395888 | Completed Phase 3 Results

• 1 other identifier: 115247
• Study Type: interventional
• Target: 260
• Locations: 7 countries
• Sites: 55

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84)

  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.

  Baseline to Day 84 (Early Withdrawal)

Study Arms (2)

Relovair

EXPERIMENTAL

Inhaled long-acting bronchodilator and corticosteroid combination

Drug: fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI)

Tiotropium

ACTIVE COMPARATOR

Inhaled long-acting anticholinergic

Drug: Tiotropium

Interventions

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)

Relovair

Tiotropium DRUG

• Tiotropium (18 mcg) administered QD via a HandiHaler

Tiotropium

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Body Mass Index of less then or equal to 35

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (55)

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1056ABJ, Argentina

Location

GSK Investigational Site

Rosario, Santa Fe Province, S2000JKR, Argentina

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GSK Investigational Site

Buenos Aires, C1424BSF, Argentina

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GSK Investigational Site

Buenos Aires, C1425BEN, Argentina

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GSK Investigational Site

Buenos Aires, C1426ABP, Argentina

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GSK Investigational Site

Mendoza, 5500, Argentina

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GSK Investigational Site

Mendoza, M5500CCG, Argentina

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GSK Investigational Site

San Juan, 5400, Argentina

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GSK Investigational Site

San Miguel de Tucumán, 4000, Argentina

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GSK Investigational Site

San Miguel de Tucumán, T4000DGF, Argentina

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GSK Investigational Site

Béthune, 62408, France

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GSK Investigational Site

Grenoble, 38043, France

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GSK Investigational Site

Lille, 59000, France

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GSK Investigational Site

Montpellier, 34295, France

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GSK Investigational Site

Reims, 51092, France

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GSK Investigational Site

Saint-Michel, 16470, France

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GSK Investigational Site

Immenhausen, Hesse, 34376, Germany

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GSK Investigational Site

Hanover, Lower Saxony, 30159, Germany

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GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19055, Germany

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GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

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GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

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GSK Investigational Site

Geesthacht, Schleswig-Holstein, 21502, Germany

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GSK Investigational Site

Berlin, 10787, Germany

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GSK Investigational Site

Berlin, 10789, Germany

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GSK Investigational Site

Berlin, 13125, Germany

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GSK Investigational Site

Hamburg, 20354, Germany

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GSK Investigational Site

Cassano Murge (BA), Apulia, 70020, Italy

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GSK Investigational Site

Eboli (SA), Campania, 84025, Italy

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GSK Investigational Site

Bologna, Emilia-Romagna, 40138, Italy

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GSK Investigational Site

Crema, Lombardy, 26013, Italy

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GSK Investigational Site

Pavia, Lombardy, 27100, Italy

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GSK Investigational Site

Bergen, 5017, Norway

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GSK Investigational Site

Bergen, N-5021, Norway

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GSK Investigational Site

Drammen, 3004, Norway

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GSK Investigational Site

Fredrikstad, 1606, Norway

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GSK Investigational Site

Skedsmokorset, N-2020, Norway

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GSK Investigational Site

Chita, 672000, Russia

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GSK Investigational Site

Kemerovo, 650002, Russia

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GSK Investigational Site

Kokhma, 153511, Russia

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GSK Investigational Site

Moscow, 105077, Russia

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GSK Investigational Site

Moscow, 115093, Russia

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GSK Investigational Site

Penza, 440067, Russia

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GSK Investigational Site

Saint Petersburg, 197022, Russia

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GSK Investigational Site

Saratov, 410053, Russia

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GSK Investigational Site

Vladivostok, Primorskiy Kray, 690022, Russia

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GSK Investigational Site

Voronezh, 394018, Russia

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GSK Investigational Site

Yaroslavl, 150003, Russia

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GSK Investigational Site

Yaroslavl, 150062, Russia

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GSK Investigational Site

Cherkassy, 18009, Ukraine

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GSK Investigational Site

Donetsk, 83099, Ukraine

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GSK Investigational Site

Kharkiv, 61035, Ukraine

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GSK Investigational Site

Kiev, 03680, Ukraine

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GSK Investigational Site

Kyiv, 03038, Ukraine

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GSK Investigational Site

Kyiv, 03049, Ukraine

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GSK Investigational Site

Yalta, 98603, Ukraine

Location

Related Publications (1)

• 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 Dec;146(6):1521-1530. doi: 10.1378/chest.13-2859.

  PMID: 25058845 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

fluticasone furoate; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: June 30, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 6, 2012
• Last Updated: February 15, 2018
• Results First Posted: August 9, 2013

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

IT (5); DE (10); AR (10); FR (6); NO (5); UA (7); RU (12)