Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease

October 9, 2017 updated by: GlaxoSmithKline

A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate /Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once-Daily Via a Novel Dry Powder Inhaler Compared With Tiotropium Bromide Inhalation Powder 18mcg Delivered Once-Daily Via the HandiHaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Who Have or Are at Risk for Co-morbid Cardiovascular Disease

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind, double-dummy, multi-center, parallel-group study. Subjects who meet the eligibility criteria at Screening and at the end of a 2-week Run-In Period will enter a 12-week Treatment Period. There will be a 7-day Follow-up Period after the Treatment Period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
623

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • GSK Investigational Site
    • Nova Scotia
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5V 2T3
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2W 1T8
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H4N 3C5
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • GSK Investigational Site
      • St-Charles-Borromée, Quebec, Canada, J6E 2B4
        • GSK Investigational Site
      • St-Romuald, Quebec, Canada, G6W 5M6
        • GSK Investigational Site
  • Czechia
      • Kralupy nad Vltavou, Czechia, 278 01
        • GSK Investigational Site
      • Kromeriz, Czechia, 767 55
        • GSK Investigational Site
      • Teplice, Czechia, 415 10
        • GSK Investigational Site
      • Trebic, Czechia, 674 01
        • GSK Investigational Site
      • Zamberk, Czechia, 564 01
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • GSK Investigational Site
      • Berlin, Germany, 10717
        • GSK Investigational Site
      • Berlin, Germany, 10787
        • GSK Investigational Site
      • Berlin, Germany, 10789
        • GSK Investigational Site
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03050
        • GSK Investigational Site
      • Ruedersdorf, Brandenburg, Germany, 15562
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
        • GSK Investigational Site
      • Neu-Isenburg, Hessen, Germany, 63263
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01069
        • GSK Investigational Site
      • Leipzg, Sachsen, Germany, 04109
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39112
        • GSK Investigational Site
    • Schleswig-Holstein
      • Grosshansdorf, Schleswig-Holstein, Germany, 22927
        • GSK Investigational Site
  • Poland
      • Bialystok, Poland
        • GSK Investigational Site
      • Czestochowa, Poland, 42-200
        • GSK Investigational Site
      • Dzialdowo, Poland, 13-200
        • GSK Investigational Site
      • Krakow, Poland, 31-024
        • GSK Investigational Site
      • Piekary Slaskie, Poland, 41-940
        • GSK Investigational Site
      • Slupsk, Poland, 76-200
        • GSK Investigational Site
      • Tarnow, Poland, 33-100
        • GSK Investigational Site
  • Romania
      • Bucharest, Romania, 050159
        • GSK Investigational Site
      • Bucharest, Romania, 020125
        • GSK Investigational Site
      • Bucharest, Romania, 030317
        • GSK Investigational Site
      • Bucuresti, Romania, 70000
        • GSK Investigational Site
      • Cluj Napoca, Romania, 400371
        • GSK Investigational Site
      • Cluj-Napoca, Romania, 400371
        • GSK Investigational Site
      • Constanta, Romania, 900002
        • GSK Investigational Site
      • Iasi, Romania, 700115
        • GSK Investigational Site
      • Suceava, Romania, 720284
        • GSK Investigational Site
      • Timisoara, Romania, 300310
        • GSK Investigational Site
  • United States
    • California
      • Newport Beach, California, United States, 92663
        • GSK Investigational Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • GSK Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97404
        • GSK Investigational Site
    • South Carolina
      • Gaffney, South Carolina, United States, 29340
        • GSK Investigational Site
      • Greenville, South Carolina, United States, 29615
        • GSK Investigational Site
      • Seneca, South Carolina, United States, 29678
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
      • Union, South Carolina, United States, 29379
        • GSK Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed and dated written informed consent
  • Male or females ≥ 40 years of age
  • Females must be post-menopausal or using a highly effective method for avoidance of pregnancy
  • Established clinical history of COPD by ATS/ERS definition
  • Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≥30 to ≤ 70% of predicted normal (NHANES III)
  • Former or current smoker ≥10 pack years
  • A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following:
  • Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD)
  • Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD)
  • Previous stroke
  • Objectively confirmed transient ischemic attack (TIA) (i.e., transient neurological deficit documented by a health-care professional)
  • Previous myocardial infarction (MI) (Note: An MI within 6 months prior to Visit 1 is exclusionary)

OR

  • Presence of one of the following cardiovascular risk factors (in addition to being a former/current smoker):
  • Current diagnosis of hypertension
  • Current diagnosis of hypercholesterolemia
  • Diabetes mellitus treated with pharmacotherapy

Exclusion Criteria:

  • Current diagnosis of asthma
  • Subjects with other respiratory disorders including α1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
  • Lung volume reduction surgery within previous 12 months
  • Clinically significant abnormalities not due to COPD by chest X-ray or CT scan
  • Hospitalized for poorly controlled COPD within 12 weeks of Screening
  • Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician
  • Lower respiratory infection requiring antibiotics 6 weeks prior to Screening
  • A moderate or severe COPD exacerbation and/or a lower respiratory tract infection (including pnuemonia) during the Run-In Period
  • An abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization
  • An abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization
  • An abnormal, clinically significant Holter finding at Screening (Visit 1) or upon repeat prior to randomization (sub-set of subjects)
  • Historical or current evidence of clinically significant (in opinion of the Investigator) and unstable disease such as cardiovascular (e.g., patients requiring ICD, pacemaker requiring a ventricular pace rate set at >60 bpm, uncontrolled hypertension, New York Heart Association Class IV (New York Heart Association,1994), known left ventricular ejection fraction <30%), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities
  • Carcinoma not in complete remission for at least 5 years
  • History of allergy or hypersensitivity to any of the study medications (e.g., anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate) or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subject's participation will also be excluded
  • Known/suspected history of alcohol or drug abuse in the last 2 years
  • Women who are pregnant or lactating or plan to become pregnant
  • Subjects medically unable to withhold albuterol /salbutamol for 4 hours prior to spirometry testing at each study visit
  • Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)
  • Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day
  • Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study
  • Failure to demonstrate adequate compliance defined as completion of the Diary Card (completed all diary entries on at least 4 of the last 7 consecutive days), the ability to withhold COPD medications and to keep clinic visit appointments
  • Non-compliance or inability to comply with study procedures or scheduled visits
  • History of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
  • Affiliation with investigator site
  • Women who are pregnant or lactating or are planning on becoming pregnant during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: fluticasone furoate/vilanterol
inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA)
Drug: fluticasone furoate/vilanterol 100/25mcg
inhalation powder
Active Comparator: tiotropium bromide
anticholinergic
Drug: tiotropium bromide 18mcg
inhalation powder
Other Names:
  • Spiriva

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84
Time Frame: Baseline and Day 84
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.
Baseline and Day 84

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Onset on Treatment Day 1
Time Frame: Baseline and Day 1
Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 minutes (min), 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. Time to onset was analyzed using a log-rank test, stratified by exacerbation history and reversibility stratum.
Baseline and Day 1
Change From Baseline in Trough FEV1 at Treatment Day 84
Time Frame: Baseline and Day 84
Pulmonary function was measured by FEV1. Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 84. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an ANCOVA model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.
Baseline and Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 115805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Informed Consent Form
    Information identifier: 115805
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: 115805
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: 115805
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: 115805
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: 115805
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: 115805
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistical Analysis Plan
    Information identifier: 115805
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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