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A Randomised Effectiveness St...

A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)

Last Updated: 2017-05-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2802 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-13

Study Completion Date

2015-11-24

Brief Summary

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This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444)) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing COPD maintenance therapy over twelve months in subjects diagnosed with COPD. This is a Phase III multi-centre, randomised open label study. Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period.

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Detailed Description

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This is a Phase III multi-centre, randomised open label study performed in subjects followed in primary care who have a diagnosis of and receive regular treatment for COPD in a localised geographical region of the UK

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FF/VI

once daily via a Novel Dry Powder Inhaler

Group Type EXPERIMENTAL

FF/VI

Intervention Type DRUG

FF/VI

Existing Maintenance Therapy

Existing Maintenance Therapy:

* Long acting bronchodilator therapy alone
* ICS alone or in combination with a long acting bronchodilator
* Triple maintenance therapy

Group Type OTHER

Existing Maintenance Therapy

Intervention Type OTHER

Existing Maintenance Therapy:

* Long acting bronchodilator therapy alone
* ICS alone or in combination with a long acting bronchodilator
* Triple maintenance therapy

Interventions

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FF/VI

Intervention Type DRUG

Existing Maintenance Therapy

Existing Maintenance Therapy:

* Long acting bronchodilator therapy alone
* ICS alone or in combination with a long acting bronchodilator
* Triple maintenance therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Subjects eligible for enrolment in the study must meet all of the following criteria:

1. Type of subject: Subjects with documented GP diagnosis of COPD, and currently receiving maintenance therapy
2. Informed consent: Subjects must be able to provide informed consent, have their consent signed and dated. Subjects must be able to complete the electronic subject questionnaires or allow a proxy to do so on their behalf.
3. Gender and Age: Male or female subjects aged ≥40 years of age at Visit 1 A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH \> 40MIU/ml and estradiol \<40pg/ml (\<140 pmol/L) is confirmatory. Or child bearing potential has a negative urine pregnancy test at Visit 2, and agrees to one of the highly effective and acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - Visit 2 to the end of the study).
4. Subjects with Exacerbation History
5. Current COPD Maintenance Therapy

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in the study:

1. Subjects with any life threatening condition (e.g. low probability (in the opinion of the GP/Investigator) of 12 month survival due to severity of COPD or co-morbid condition) at the point of entry into the study.
2. Other diseases/abnormalities: Subjects with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the GP/ Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
3. Subjects with unstable COPD, defined as the occurrence of the following in the 2 weeks prior to Visit 2:

\- Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician.
4. Chronic user of oral corticosteroids: Subjects who, in the opinion of the GP/Investigator, are considered to be a chronic user of oral corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening)
5. Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the GP/ Investigator, contraindicates the subject's participation will also be excluded.
6. Investigational Medications: A subject must not have used any investigational drug treatment within 30 days prior to Visit 2 or within five half-lives (t½) of the prior investigational study (whichever is the longer of the two).
7. Subjects who plan to move away from the geographical area where the study is being conducted during the study period and/or if subjects have not consented to their medical records being part of the electronic medical records database that is operational in the Salford area.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Altrincham, Cheshire, United Kingdom

Site Status

GSK Investigational Site

Altrincham, Cheshire, United Kingdom

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GSK Investigational Site

Altrincham, Cheshire, United Kingdom

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GSK Investigational Site

Altrincham, Cheshire, United Kingdom

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GSK Investigational Site

Altrincham, Cheshire, United Kingdom

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GSK Investigational Site

Bowdon, Cheshire, United Kingdom

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GSK Investigational Site

Cheadle, Cheshire, United Kingdom

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GSK Investigational Site

Cheadle Hulme, Cheshire, United Kingdom

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GSK Investigational Site

Edgeley, Cheshire, United Kingdom

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GSK Investigational Site

Gatley, Cheshire, United Kingdom

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GSK Investigational Site

Heald Green, Cheshire, United Kingdom

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GSK Investigational Site

Sale, Cheshire, United Kingdom

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GSK Investigational Site

Sale, Cheshire, United Kingdom

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GSK Investigational Site

Sale, Cheshire, United Kingdom

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GSK Investigational Site

Sale, Cheshire, United Kingdom

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GSK Investigational Site

Stockport, Cheshire, United Kingdom

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GSK Investigational Site

Timperley, Cheshire, United Kingdom

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GSK Investigational Site

Timperley, Cheshire, United Kingdom

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GSK Investigational Site

Altrincham, Greater Manchester, United Kingdom

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GSK Investigational Site

Altrincham, Greater Manchester, United Kingdom

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GSK Investigational Site

Broadway, Davyhulme, Greater Manchester, United Kingdom

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GSK Investigational Site

Irlam, Greater Manchester, United Kingdom

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