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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01551758
First received: March 1, 2012
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: FF/VI
Other: Existing Maintenance Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-month, Open Label, Randomised, Effectiveness Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler (NDPI) Compared With the Existing COPD Maintenance Therapy Alone in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean annual rate of moderate and severe exacerbations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A moderate exacerbation is defined by the subject receiving an exacerbation-related prescription of oral corticosteroids and/ or antibiotic (with NHS contact) not requiring hospitalisation. A severe exacerbation is defined as an exacerbation-related hospitalisation.


Secondary Outcome Measures:
  • Variety of healthcare utilisation endpoints [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Healthcare utilisation

  • Serious Adverse Events and non- serious Adverse Drug Reactions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency and type of Serious Adverse Events and non- serious Adverse Drug Reactions

  • Patient reported outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient reported outcomes


Estimated Enrollment: 2798
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FF/VI
once daily via a Novel Dry Powder Inhaler
Drug: FF/VI
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
Other: Existing Maintenance Therapy

Existing Maintenance Therapy:

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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551758

  Hide Study Locations
Locations
United Kingdom
GSK Investigational Site
Altrincham, Cheshire, United Kingdom, WA14 5PF
GSK Investigational Site
Altrincham, Cheshire, United Kingdom, WA14 5ET
GSK Investigational Site
Altrincham, Cheshire, United Kingdom, WA14 5GR
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Altrincham, Cheshire, United Kingdom, WA14 5NH
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Altrincham, Cheshire, United Kingdom, WA14 2NW
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Cheadle, Cheshire, United Kingdom, SK8 6LQ
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Cheadle Hulme, Cheshire, United Kingdom, SK8 5EG
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Edgeley, Cheshire, United Kingdom, SK3 9LQ
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Gatley, Cheshire, United Kingdom, SK84NG
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Heald Green, Cheshire, United Kingdom, SK8 3QA
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Sale, Cheshire, United Kingdom, M33 4BR
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Sale, Cheshire, United Kingdom, M33 2RH
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Sale, Cheshire, United Kingdom, M33 2UP
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Sale, Cheshire, United Kingdom, M33 7SS
GSK Investigational Site
Stockport, Cheshire, United Kingdom, SK3 9NX
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Timperley, Cheshire, United Kingdom, WA15 7DD
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Timperley, Cheshire, United Kingdom, WA15 7UN
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Altrincham, Greater Manchester, United Kingdom, WA14 2DW
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Altrincham, Greater Manchester, United Kingdom, WA15 6PH
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Broadway, Davyhulme, Greater Manchester, United Kingdom, M41 7WJ
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Irlam, Greater Manchester, United Kingdom, M44 5LH
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Irlam, Manchester, Greater Manchester, United Kingdom, M44 5LH
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Manchester, Greater Manchester, United Kingdom, M20 6WF
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Manchester, Greater Manchester, United Kingdom, M33 3HF
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Manchester, Greater Manchester, United Kingdom, M41 0TY
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Manchester, Greater Manchester, United Kingdom, M33 2TB
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Manchester, Greater Manchester, United Kingdom, M33 7SS
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Manchester, Greater Manchester, United Kingdom, M27 9LB
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Manchester, Greater Manchester, United Kingdom, M41 5AA
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Manchester, Greater Manchester, United Kingdom, M20 1EB
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Manchester, Greater Manchester, United Kingdom, M32 0PA
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Manchester, Greater Manchester, United Kingdom, M23 1JP
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Manchester, Greater Manchester, United Kingdom, WA15 7UN
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Manchester, Greater Manchester, United Kingdom, M41 0SE
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Manchester, Greater Manchester, United Kingdom, M22 5DW
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Manchester, Greater Manchester, United Kingdom, M41 0NA
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Manchester, Greater Manchester, United Kingdom, M33 4WB
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Manchester, Greater Manchester, United Kingdom, M22 4DH
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Manchester, Greater Manchester, United Kingdom, M41 7WJ
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Manchester, Greater Manchester, United Kingdom, M22 5RX
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Manchester, Greater Manchester, United Kingdom, M20 2DN
GSK Investigational Site
Manchester, Greater Manchester, United Kingdom, M22 9UE
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Manchester, Greater Manchester, United Kingdom, M41 7FN
GSK Investigational Site
Manchester, Greater Manchester, United Kingdom, M33 5PN
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Manchester, Greater Manchester, United Kingdom, M32 0DF
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Manchester, Greater Manchester, United Kingdom, M41 9DL
GSK Investigational Site
Manchester, Greater Manchester, United Kingdom, M20 2RN
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Manchester, Greater Manchester, United Kingdom, M20 3BG
GSK Investigational Site
Manchester, Greater Manchester, United Kingdom, M23 9AB
GSK Investigational Site
Manchester, Greater Manchester, United Kingdom, M33 5JD
GSK Investigational Site
Manchester, Greater Manchester, United Kingdom, M32 0RW
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Manchester, Greater Manchester, United Kingdom, M22 5RB
GSK Investigational Site
Newall Green, Greater Manchester, United Kingdom, M23 2SY
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Northern Moor, Greater Manchester, United Kingdom, M23 0BX
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Pendlebury, Greater Manchester, United Kingdom, M27 8HP
GSK Investigational Site
Pendlebury, Manchester, Greater Manchester, United Kingdom, M27 8HP
GSK Investigational Site
Salford, Greater Manchester, United Kingdom, M7 1RD
GSK Investigational Site
Salford, Greater Manchester, United Kingdom, M6 5PW
GSK Investigational Site
Salford, Greater Manchester, United Kingdom, M6 7HL
GSK Investigational Site
Salford, Greater Manchester, United Kingdom, M6 6ES
GSK Investigational Site
Salford, Manchester, Greater Manchester, United Kingdom, M7 4TP
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Stretford, Greater Manchester, United Kingdom, M32 9BD
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Timperley, Greater Manchester, United Kingdom, WA15 6PH
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Withington, Greater Manchester, United Kingdom, M20 1EY
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Wythenshawe, Greater Manchester, United Kingdom, M22 0EP
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Wythenshawe, Greater Manchester, United Kingdom, M22 5RX
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Wythenshawe, Greater Manchester, United Kingdom, M22 5RN
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Cadishead, Manchester, United Kingdom, M44 5DD
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Cheadle, United Kingdom, SK8 5BB
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Eccles, United Kingdom, M30 0TU
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Eccles, Manchester, United Kingdom, M30 8QD
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Eccles, Manchester, United Kingdom, M30 9PS
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Eccles, Manchester, United Kingdom, M30 7NA
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Eccles, Manchester, United Kingdom, M30 8JA
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Eccles, Manchester, United Kingdom, M30 0LS
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Eccles, Manchester, United Kingdom, M30 0NU
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Eccles, Manchester, United Kingdom, M30 7JW
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Eccles, Manchester, United Kingdom, M30 0TU
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Eccles, Manchester, United Kingdom, M30 8AR
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Eccles, Manchester, United Kingdom, M30 0EA
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Eccles, Manchester, United Kingdom, M30 0PF
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Eccles, Manchester, United Kingdom, M30 0EJ
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Ellenbrook, Manchester, United Kingdom, M28 1PB
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Irlam, Manchester, United Kingdom, M44 6FN
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Irlam, Manchester, United Kingdom, M44 6FE
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Irlam, Manchester, United Kingdom, M44 5LH
GSK Investigational Site
Irlam, Manchester, United Kingdom, M44 6BL
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Irlam, Manchester, United Kingdom, M44 6AJ
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Irlam, Salford, United Kingdom, M44 6ZS
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Irlam, Salford, United Kingdom, M44 6DP
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Little Hulton, Manchester, United Kingdom, M38 9RS
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Little Hulton, Manchester, United Kingdom, M38 9WX
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Little Hulton, Manchester, United Kingdom, M28 0AY
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Little Hulton, Manchester, United Kingdom, M38 9GH
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Little Hulton, Manchester, United Kingdom, M38 9LQ
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Little Hulton, Manchester, United Kingdom, M38 9GR
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Little Hulton, Manchester, United Kingdom, M28 0BA
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Manchester, United Kingdom, M33 4DX
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Manchester, United Kingdom, M41 8TW
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Manchester, United Kingdom, M41 9NU
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Manchester, United Kingdom, M22 4QN
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Manchester, United Kingdom, M22 4HD
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Manchester, United Kingdom, M32 9PA
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Manchester, United Kingdom, M41 9SB
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Manchester, United Kingdom, M33 3JS
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Manchester, United Kingdom, M41 9FD
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Manchester, United Kingdom, M20 4SS
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Manchester, United Kingdom, M41 8GY
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Manchester, United Kingdom, M23 1JX
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Manchester, United Kingdom, M33 7XZ
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Manchester, United Kingdom, M41 5BG
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Manchester, United Kingdom, M32 8AQ
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Manchester, United Kingdom, M7 4PF
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Manchester, United Kingdom, M28 1PB
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Pendlebury, Manchester, United Kingdom, M27 6EW
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Salford, United Kingdom, M7 4LZ
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Salford, United Kingdom, M6 5FX
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Salford, United Kingdom, M6 6ES
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Salford, United Kingdom, M6 5PP
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Salford, United Kingdom, M6 5QQ
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Salford, United Kingdom, M6 5JG
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Salford, United Kingdom, M7 3SE
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Salford, United Kingdom, M6 3PH
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Salford, United Kingdom, M5 3PH
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Salford, United Kingdom, M5 4BS
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Salford, United Kingdom, M7 4TP
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Salford, Manchester, United Kingdom, M7 1QE
GSK Investigational Site
Salford, Manchester, United Kingdom, M6 5WW
GSK Investigational Site
Salford, Manchester, United Kingdom, M5 3TP
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Salford, Manchester, United Kingdom, M6 8HA
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Salford, Manchester, United Kingdom, M5 5JR
GSK Investigational Site
Salford, Manchester, United Kingdom, M6 5FX
GSK Investigational Site
Salford, Manchester, United Kingdom, M6 5JA
GSK Investigational Site
Salford, Manchester, United Kingdom, M6 7HL
GSK Investigational Site
Salford, Manchester, United Kingdom, M6 5PH
GSK Investigational Site
Salford, Manchester, United Kingdom, M7 1UD
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Salford, Manchester, United Kingdom, M5 5HJ
GSK Investigational Site
Salford, Manchester, United Kingdom, M3 6BY
GSK Investigational Site
Salford, Manchester, United Kingdom, M7 3SE
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Salford, Manchester, United Kingdom, M7 4UF
GSK Investigational Site
Salford, Manchester, United Kingdom, M5 4QU
GSK Investigational Site
Salford, Manchester, United Kingdom, M6 5WN
GSK Investigational Site
Salford, Manchester, United Kingdom, M6 5JS
GSK Investigational Site
Salford, Manchester, United Kingdom, M6 8NR
GSK Investigational Site
Salford, Manchester, United Kingdom, M6 7GU
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Salford, Manchester, United Kingdom, M3 6AF
GSK Investigational Site
Salford, Manchester, United Kingdom, M6 8LE
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Salford, Manchester, United Kingdom, M7 1RD
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Salford, Manchester, United Kingdom, M7 4AE
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Salford, Manchester, United Kingdom, M7 4AS
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Stockport, United Kingdom, SK2 7EY
GSK Investigational Site
Stockport, United Kingdom, SK8 3QA
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Stockport, United Kingdom, SK8 3JD
GSK Investigational Site
Stockport, United Kingdom, SK3 9AD
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Stockport, United Kingdom, SK8 5LL
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Swinton, United Kingdom, M27 8HP
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Swinton, United Kingdom, M27 4BJ
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Swinton, Manchester, United Kingdom, M27 0NA
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Swinton, Manchester, United Kingdom, M27 4BH
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Swinton, Manchester, United Kingdom, M27 0EW
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Swinton, Manchester, United Kingdom, M27 4AF
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Walkden, Manchester, United Kingdom, M28 3AT
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Walkden, Manchester, United Kingdom
GSK Investigational Site
Walkden, Manchester, United Kingdom, M28 3BT
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Walkden, Manchester, United Kingdom, M28 3EZ
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Walkden, Manchester, United Kingdom, M28 3DR
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Walkden, Manchester, United Kingdom, M28 3ZD
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Worsley, Manchester, United Kingdom, M28 3AT
GSK Investigational Site
Worsley, Manchester, United Kingdom, M28 1LZ
GSK Investigational Site
Worsley, Manchester, United Kingdom, M28 1FB
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01551758     History of Changes
Other Study ID Numbers: 115151
Study First Received: March 1, 2012
Last Updated: November 13, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Respiratory
Exacerbation
Adult
COPD

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Bronchodilator Agents
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014