Subjects with Chronic Obstructive Pulmonary Disease (COPD). MedDRA version: 18.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 1798
Exclusion criteria
Exclusion criteria: 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. Patients with an exacerbation (defined by treatment with oral corticosteroids and/or antibiotic) with an onset within 2 weeks of V2 must not be randomised. Randomisation should be delayed until at least 2 weeks after the onset of an exacerbation and until the exacerbation has resolved 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 and South Manchester area 8. Subjects whose current medications include RELVAR are not eligible to enter the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to compare the effectiveness and safety of fluticasone furoate (FF)/vilanterol (VI) Inhalation Powder 100mcg/25mcg with other maintenance therapy over twelve months in a large UK primary care population of subjects with COPD. FF/VI will be administered once-daily (QD) in the morning via the Novel Dry Powder Inhaler (NDPI).; Secondary Objective: The secondary objective of this study is to compare the incidence of serious adverse events of pneumonia in patients receiving fluticasone furoate (FF)/vilanterol (VI) Inhalation Powder 100mcg/25mcg with patients receiving their existing COPD maintenance therapy over twelve months. We will also compare the incidence of serious pneumonia in patients receiving fluticasone furoate (FF)/vilanterol (VI) Inhalation Powder 100mcg/25mcg to the incidence on those who continued existing COPD maintenance therapy which includes an ICS and on those continuing FP/salmeterol (the most frequently used ICS/LABA at baseline). ; Primary end point(s): The primary endpoint is the mean annual rate of moderate or severe exacerbations, where - A moderate exacerbation is defined as: • the subjects receiving an exacerbation-related prescription1 of oral corticosteroids and/or antibiotics with or without NHS contact2,3,4,5 not requiring hosptialisation - A severe exacerbation is defined as an exacerbation-related hospitalisation2,6 ;Timepoint(s) of evaluation of this end point: Moderate and severe exacerbations occurring during the entire study | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Endpoint data will be captured during the entire study.; Secondary end point(s): • COPD-related secondary care contacts1,3 • COPD-related primary care contacts1,2,3 • All secondary care contacts1 • All primary care contacts1,2 • Time to discontinuation of initial therapy (i.e. therapy the subject is randomised to) • Time to addition of a further COPD controller medication • Time to first moderate/severe exacerbation • Time to first severe exacerbation (i.e. hospitalisation) | — |
Countries
United Kingdom
Contacts
Public ContactClincial Trials Helpdesk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed