Pulmonary Disease, Chronic Obstructive Clinical Trial
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)
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.
| Status | Completed |
| Enrollment | 2802 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | GSK Investigational Site | Altrincham | Cheshire |
| United Kingdom | GSK Investigational Site | Altrincham | Cheshire |
| United Kingdom | GSK Investigational Site | Altrincham | Cheshire |
| United Kingdom | GSK Investigational Site | Altrincham | Cheshire |
| United Kingdom | GSK Investigational Site | Altrincham | Cheshire |
| United Kingdom | GSK Investigational Site | Altrincham | Greater Manchester |
| United Kingdom | GSK Investigational Site | Altrincham | Greater Manchester |
| United Kingdom | GSK Investigational Site | Bowdon | Cheshire |
| United Kingdom | GSK Investigational Site | Broadway, Davyhulme | Greater Manchester |
| United Kingdom | GSK Investigational Site | Cadishead, Manchester | |
| United Kingdom | GSK Investigational Site | Cheadle | |
| United Kingdom | GSK Investigational Site | Cheadle | Cheshire |
| United Kingdom | GSK Investigational Site | Cheadle Hulme | Cheshire |
| United Kingdom | GSK Investigational Site | Eccles | |
| United Kingdom | GSK Investigational Site | Eccles, Manchester | |
| United Kingdom | GSK Investigational Site | Eccles, Manchester | |
| United Kingdom | GSK Investigational Site | Eccles, Manchester | |
| United Kingdom | GSK Investigational Site | Eccles, Manchester | |
| United Kingdom | GSK Investigational Site | Eccles, Manchester | |
| United Kingdom | GSK Investigational Site | Eccles, Manchester | |
| United Kingdom | GSK Investigational Site | Eccles, Manchester | |
| United Kingdom | GSK Investigational Site | Eccles, Manchester | |
| United Kingdom | GSK Investigational Site | Eccles, Manchester | |
| United Kingdom | GSK Investigational Site | Eccles, Manchester | |
| United Kingdom | GSK Investigational Site | Eccles, Manchester | |
| United Kingdom | GSK Investigational Site | Eccles, Manchester | |
| United Kingdom | GSK Investigational Site | Edgeley | Cheshire |
| United Kingdom | GSK Investigational Site | Ellenbrook, Manchester | |
| United Kingdom | GSK Investigational Site | Gatley | Cheshire |
| United Kingdom | GSK Investigational Site | Heald Green | Cheshire |
| United Kingdom | GSK Investigational Site | Irlam | Greater Manchester |
| United Kingdom | GSK Investigational Site | Irlam, Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Irlam, Manchester | |
| United Kingdom | GSK Investigational Site | Irlam, Manchester | |
| United Kingdom | GSK Investigational Site | Irlam, Manchester | |
| United Kingdom | GSK Investigational Site | Irlam, Manchester | |
| United Kingdom | GSK Investigational Site | Irlam, Manchester | |
| United Kingdom | GSK Investigational Site | Irlam, Salford | |
| United Kingdom | GSK Investigational Site | Irlam, Salford | |
| United Kingdom | GSK Investigational Site | Little Hulton, Manchester | |
| United Kingdom | GSK Investigational Site | Little Hulton, Manchester | |
| United Kingdom | GSK Investigational Site | Little Hulton, Manchester | |
| United Kingdom | GSK Investigational Site | Little Hulton, Manchester | |
| United Kingdom | GSK Investigational Site | Little Hulton, Manchester | |
| United Kingdom | GSK Investigational Site | Little Hulton, Manchester | |
| United Kingdom | GSK Investigational Site | Little Hulton, Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Newall Green | Greater Manchester |
| United Kingdom | GSK Investigational Site | Northenden | Greater Manchester |
| United Kingdom | GSK Investigational Site | Northern Moor | Greater Manchester |
| United Kingdom | GSK Investigational Site | Pendlebury | Greater Manchester |
| United Kingdom | GSK Investigational Site | Pendlebury, Manchester | |
| United Kingdom | GSK Investigational Site | Pendlebury, Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Sale | Cheshire |
| United Kingdom | GSK Investigational Site | Sale | Cheshire |
| United Kingdom | GSK Investigational Site | Sale | Cheshire |
| United Kingdom | GSK Investigational Site | Sale | Cheshire |
| United Kingdom | GSK Investigational Site | Salford | Greater Manchester |
| United Kingdom | GSK Investigational Site | Salford | Greater Manchester |
| United Kingdom | GSK Investigational Site | Salford | Greater Manchester |
| United Kingdom | GSK Investigational Site | Salford | Greater Manchester |
| United Kingdom | GSK Investigational Site | Salford | |
| United Kingdom | GSK Investigational Site | Salford | |
| United Kingdom | GSK Investigational Site | Salford | |
| United Kingdom | GSK Investigational Site | Salford | |
| United Kingdom | GSK Investigational Site | Salford | |
| United Kingdom | GSK Investigational Site | Salford | |
| United Kingdom | GSK Investigational Site | Salford | |
| United Kingdom | GSK Investigational Site | Salford | |
| United Kingdom | GSK Investigational Site | Salford | |
| United Kingdom | GSK Investigational Site | Salford | |
| United Kingdom | GSK Investigational Site | Salford | |
| United Kingdom | GSK Investigational Site | Salford | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | Greater Manchester |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Salford, Manchester | |
| United Kingdom | GSK Investigational Site | Stockport | |
| United Kingdom | GSK Investigational Site | Stockport | |
| United Kingdom | GSK Investigational Site | Stockport | |
| United Kingdom | GSK Investigational Site | Stockport | |
| United Kingdom | GSK Investigational Site | Stockport | |
| United Kingdom | GSK Investigational Site | Stockport | Cheshire |
| United Kingdom | GSK Investigational Site | Stretford | Greater Manchester |
| United Kingdom | GSK Investigational Site | Swinton | |
| United Kingdom | GSK Investigational Site | Swinton | |
| United Kingdom | GSK Investigational Site | Swinton, Manchester | |
| United Kingdom | GSK Investigational Site | Swinton, Manchester | |
| United Kingdom | GSK Investigational Site | Swinton, Manchester | |
| United Kingdom | GSK Investigational Site | Swinton, Manchester | |
| United Kingdom | GSK Investigational Site | Timperley | Greater Manchester |
| United Kingdom | GSK Investigational Site | Timperley | Cheshire |
| United Kingdom | GSK Investigational Site | Timperley | Cheshire |
| United Kingdom | GSK Investigational Site | Walkden, Manchester | |
| United Kingdom | GSK Investigational Site | Walkden, Manchester | |
| United Kingdom | GSK Investigational Site | Walkden, Manchester | |
| United Kingdom | GSK Investigational Site | Walkden, Manchester | |
| United Kingdom | GSK Investigational Site | Walkden, Manchester | |
| United Kingdom | GSK Investigational Site | Walkden, Manchester | |
| United Kingdom | GSK Investigational Site | Withington | Greater Manchester |
| United Kingdom | GSK Investigational Site | Worsley, Manchester | |
| United Kingdom | GSK Investigational Site | Worsley, Manchester | |
| United Kingdom | GSK Investigational Site | Worsley, Manchester | |
| United Kingdom | GSK Investigational Site | Wythenshawe | |
| United Kingdom | GSK Investigational Site | Wythenshawe | Greater Manchester |
| United Kingdom | GSK Investigational Site | Wythenshawe | Greater Manchester |
| United Kingdom | GSK Investigational Site | Wythenshawe | Greater Manchester |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean annual rate of moderate and severe exacerbations | A moderate exacerbation is defined by the subject receiving an exacerbation-related prescription of oral corticosteroids and/ or antibiotic (with or without NHS contact) not requiring hospitalisation. A severe exacerbation is defined as an exacerbation-related hospitalisation. | 12 months | No |
| Secondary | COPD-related secondary care contacts | All contacts are defined as any encounter the subject may have with a doctor, nurse or other healthcare professionals working as part of the NHS (including telephone calls). COPD-related contacts are defined as COPD-related if the most prominent signs and symptoms the patient was presenting were, as a direct result of the patient's COPD. | 12 months | No |
| Secondary | COPD-related primary care contacts | All contacts are defined as any encounter the subject may have with a doctor, nurse or other healthcare professionals working as part of the NHS (including telephone calls). These contacts do not include protocol-defined study-related visits/contacts. COPD-related contacts are defined as COPD-related if the most prominent signs and symptoms the patient was presenting were, as a direct result of the patient's COPD. | 12 months | No |
| Secondary | All secondary care contacts | All contacts are defined as any encounter the subject may have with a doctor, nurse or other healthcare professionals working as part of the NHS (including telephone calls). | 12 months | No |
| Secondary | All primary care contacts | All contacts are defined as any encounter the subject may have with a doctor, nurse or other healthcare professionals working as part of the NHS (including telephone calls). These contacts do not include protocol-defined study-related visits/contacts | 12 months | No |
| Secondary | Time to discontinuation of initial therapy | Time to discontinuation of initial therapy (i.e. therapy the subject is randomised to) | 12 months | No |
| Secondary | Time to addition of a further COPD controller medication | Time to addition of a further COPD controller medication | 12 months | No |
| Secondary | Time to first moderate/severe exacerbation | A moderate exacerbation is defined as the subject receiving an exacerbation-related prescription of oral corticosteroids and/ or antibiotic with or without NHS contact not requiring hospitalisation. | 12 months | No |
| Secondary | Time to first severe exacerbation (i.e. hospitalisation) | A severe exacerbation is defined as an exacerbation-related hospitalisation | 12 months | No |
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