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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01551758
First received: March 1, 2012
Last updated: September 25, 2014
Last verified: September 2014

March 1, 2012
September 25, 2014
January 2012
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01551758 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)
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)

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: FF/VI
    FF/VI
  • 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
  • Experimental: FF/VI
    once daily via a Novel Dry Powder Inhaler
    Intervention: 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
    Intervention: Other: Existing Maintenance Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2798
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
United Kingdom
 
NCT01551758
115151
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP