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Pulmonary Disease, Chronic ObstructivePhase 3NCT01395888

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

A Phase 3 study testing fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI) and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 55 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI) and Tiotropium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
55 sitesin 7 countries
Study dates
30 Jun 2011to 6 Aug 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 10Show fewer
  • 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).

Who cannot join

  • Body Mass Index of less then or equal to 35

Trial locations and contacts

55 sites in 7 countries.

55 sites in 7 countries

Russia12 sites

  • GSK Investigational Site

    Chita, 672000

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Kokhma, 153511

  • GSK Investigational Site

    Moscow, 105077

  • GSK Investigational Site

    Moscow, 115093

  • GSK Investigational Site

    Penza, 440067

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Saratov, 410053

  • GSK Investigational Site

    Vladivostok, Primorskiy Kray, 690022

  • GSK Investigational Site

    Voronezh, 394018

  • GSK Investigational Site

    Yaroslavl, 150003

  • GSK Investigational Site

    Yaroslavl, 150062

Other trials in Russia

Argentina10 sites

  • GSK Investigational Site

    Buenos Aires, C1424BSF

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Buenos Aires, C1426ABP

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1056ABJ

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Mendoza, M5500CCG

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000JKR

  • GSK Investigational Site

    San Juan, 5400

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

  • GSK Investigational Site

    San Miguel de Tucumán, T4000DGF

Other trials in Argentina

Germany10 sites

  • GSK Investigational Site

    Berlin, 10787

  • GSK Investigational Site

    Berlin, 10789

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Geesthacht, Schleswig-Holstein, 21502

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Hamburg, 20354

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Immenhausen, Hesse, 34376

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Schwerin, Mecklenburg-Vorpommern, 19055

Other trials in Germany

Ukraine7 sites

  • GSK Investigational Site

    Cherkassy, 18009

  • GSK Investigational Site

    Donetsk, 83099

  • GSK Investigational Site

    Kharkiv, 61035

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kyiv, 03038

  • GSK Investigational Site

    Kyiv, 03049

  • GSK Investigational Site

    Yalta, 98603

Other trials in Ukraine

France6 sites

  • GSK Investigational Site

    Béthune, 62408

  • GSK Investigational Site

    Grenoble, 38043

  • GSK Investigational Site

    Lille, 59000

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Reims, 51092

  • GSK Investigational Site

    Saint-Michel, 16470

Other trials in France

Italy5 sites

  • GSK Investigational Site

    Bologna, Emilia-Romagna, 40138

  • GSK Investigational Site

    Cassano Murge (BA), Apulia, 70020

  • GSK Investigational Site

    Crema, Lombardy, 26013

  • GSK Investigational Site

    Eboli (SA), Campania, 84025

  • GSK Investigational Site

    Pavia, Lombardy, 27100

Other trials in Italy

Norway5 sites

  • GSK Investigational Site

    Bergen, 5017

  • GSK Investigational Site

    Bergen, N-5021

  • GSK Investigational Site

    Drammen, 3004

  • GSK Investigational Site

    Fredrikstad, 1606

  • GSK Investigational Site

    Skedsmokorset, N-2020

Other trials in Norway

About this study

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).

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.

Read the detailed description

This is a Phase IIIb comparator, double-blind, double-dummy, randomised (1:1), parallel group, multi-centre study. At Visit 1 (Screening Visit), subjects who meet the pre-defined Inclusion Criteria and none of the Exclusion Criteria will enter a 2-week, single-blind placebo Run-in Period. The purpose of the Run-In Period is to monitor albuterol/salbutamol use at baseline, and to ensure that subjects' COPD is at a stable stage at randomization. Subject's adherence with study procedures, diary completion will also be evaluated during the Run-In Period. At the end of the Run-in period, subjects will be assessed and those who meet the randomisation criteria will receive one of the following two double-blind treatments for 12 weeks:

  • FF (100 mcg)/VI (25 mcg) administered QD via a NDPI in the morning
  • Tiotropium (18 mcg) administered QD via a HandiHaler in the morning

To ensure blinding of the treatments and to ensure a double-dummy design matching NDPI and HandiHaler will be utilised. Each subject will be instructed to self administer blinded study drug during the double blind treatment period as follows:

  • Each morning take 1 inhalation from NDPI containing FF (100 mcg)/VI (25 mcg) followed by 1 inhalation from placebo capsule delivered via HandiHaler.
  • Each morning take 1 inhalation from matching placebo NDPI followed by 1 inhalation from a capsule containing tiotropium 18 mcg delivered via HandiHaler.

An inhaled short acting beta2-receptor agonist, salbutamol/albuterol will be provided to subjects to use as needed throughout the Run-in and Treatment periods for relief of COPD symptoms. Ipratropium bromide is permitted if the subject is on a stable dose from Screening (Visit 1) and remains on the stable dose throughout the study. Subjects who experience an exacerbation of their COPD (which requires medication in addition to an increase in rescue medication) or a lower respiratory tract infection (LRTI) during the run-in period are not eligible to enter the treatment period. Any subject who experiences a similar COPD exacerbation (sec 4.4) or LRTI at any time on therapy will be withdrawn from the study. The aPWV will be measured at Screening and clinic Visits 3-5. Disease specific health status will be evaluated using the St. George's Respiratory Questionnaire (SGRQ-C), Euro Qol Questionnaire (EQ-5D) for COPD patients and the COPD Assessment Test (CAT) at Visit 2 (Day 1) and at Visit 5 (Weeks 12). The 12-lead ECG will be evaluated at Visit 1 (Screening) only. Vital signs (blood pressure and pulse rate), spirometry measurements, and clinical laboratory tests (hematology and chemistry) and other study-specific safety assessments will be obtained at selected clinic visits. A follow-up phone call will occur approximately 7 days after the last clinic visit. The overall study duration from Screening to Follow-up for each subject is approximately 15 weeks. Subjects will be considered to have completed the study upon completion of assessments and procedures up to and including completion of Follow-up Phone Contact (7 ± 2 days post Visit 5).

Being tested
fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI), Tiotropium
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • TiotropiumDrug

    • Tiotropium (18 mcg) administered QD via a HandiHaler
Study groups in NCT01395888
Study groupRoleWhat they receive
RelovairExperimentalInhaled long-acting bronchodilator and corticosteroid combination
Receives: Drug: fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI)
TiotropiumActive comparatorInhaled long-acting anticholinergic
Receives: Drug: Tiotropium

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Day 84 (Early Withdrawal)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2011 (estimated)
  2. Study start30 Jun 2011
  3. Primary completion1 Aug 2012
  4. Study completion6 Aug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01395888
Sponsor's protocol ID
115247
Status last verified
Jan 2018
First submitted
14 Jul 2011
Last updated
15 Feb 2018
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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

    PubMed 25058845

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI) and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 55 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Russia, Argentina, Germany, Ukraine, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84) (time frame: Baseline to Day 84 (Early Withdrawal)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01395888, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.

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