Last updated: 11/28/2018 22:02:33
A Randomised Effectiveness Study Comparing fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) with Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Mean Annual Rate of Moderate or Severe COPD Exacerbations
Timeframe: Up to 54 weeks
Secondary outcomes:
Number of participants with serious adverse events (SAEs) of pneumonia during the study
Timeframe: Up to 58 weeks
Mean number of serious adverse events of pneumonia during the study
Timeframe: Up to 58 weeks
Time to the first serious adverse event of pneumonia occuring in a year
Timeframe: Up to 52 weeks
Number of COPD-related secondary care contacts expressed as Least Square Mean
Timeframe: Up to 54 weeks
Number of COPD-related primary care contacts expressed using Least Square Mean
Timeframe: Up to 54 weeks
Number of all secondary care contacts expressed using Least Square Mean
Timeframe: Up to 54 weeks
Number of all primary care contacts expressed using Least Square Mean
Timeframe: Up to 54 weeks
Time to an event of discontinuation of initial therapy occurring in a year
Timeframe: Up to 364 days
Time to the addition of a further COPD controller medication occurring in a year
Timeframe: Up to 364 days
Time to first moderate/severe exacerbations occurring in a year
Timeframe: Up to 364 days
Time to first moderate/severe exacerbations on initial therapy occurring in a year
Timeframe: Up to 364 days
Time to first severe exacerbations occurring in a year
Timeframe: Up to 364 days
Number of participants with Fatal serious adverse events of pneumonia
Timeframe: Upto 58 weeks
Number of participants with non-serious adverse drug reactions (ADR)
Timeframe: Up to 54 weeks
Number of participants with serious adverse events
Timeframe: Up to 56 weeks
Number of participants with serious adverse drug reactions
Timeframe: Upto 12 months
Interventions:
Enrollment:
2802
Primary completion date:
2015-24-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Jørgen Vestbo, David Leather, Nawar Diar Bakerly, John New, J. Martin Gibson, Sheila McCorkindale, Susan Collier, Jodie Crawford, Lucy Frith, Catherine Harvey, Henrik Svedsater, Ashley Woodcock. Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice. N Engl J Med. 2016;375:1253-1260.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, vilanterol
Collaborators
Not applicable
Study date(s)
March 2012 to November 2015
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- 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
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Manchester, Greater Manchester, United Kingdom, M20 2DN
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Salford, Manchester, United Kingdom, M7 1RD
Status
Study Complete
Location
GSK Investigational Site
Little Hulton, Manchester, United Kingdom, M38 9GH
Status
Study Complete
Location
GSK Investigational Site
Manchester, United Kingdom, M41 8TW
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Worsley, Manchester, United Kingdom, M28 1LZ
Status
Study Complete
Location
GSK Investigational Site
Ellenbrook, Manchester, United Kingdom, M28 1PB
Status
Terminated/Withdrawn
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Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2015-24-11
Actual study completion date
2015-24-11
Plain language summaries
Summary of results in plain language
Available language(s): English (UK)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
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