Asthma MedDRA version: 18.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: 1. 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. 2. Type of subject: Subjects with documented GP diagnosis of asthma as their primary respiratory disease. 3. Current Anti-Asthma Therapy: All subjects must be prescribed maintenance therapy and receiving ICS with or without LABA (either a fixed combination or via separate inhalers), and for at least 4 weeks prior to Visit 2. • Other background asthma medication such as anti-leukotrienes are permitted 4. All subjects on ICS monotherapy or ICS/LABA combination (this can be a fixed dose combination or an ICS alone or LABA alone in separate inhalers) must have had symptoms in the past week prior to Visit 2. Symptoms are defined by daytime symptoms more than twice per week, use of short-acting beta2-agonist bronchodilator more than twice per week, any limitation of activities, or any nocturnal symptoms/awakening. (The symptoms are based on subject’s recall and are consistent with the GINA and in principal with the BTS/SIGN guidelines). 5. Subject questionnaires: Subjects must be able to complete the electronic subject questionnaires as well as those questionnaires that are completed by phone or provide a proxy e.g. a partner/relative/a friend who can do so on their behalf 6. Gender and Age: Male or female subjects aged ?18 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 300
Exclusion criteria
Exclusion criteria: 1. Recent history of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 6 months. 2. COPD Respiratory Disease: A subject must not have current evidence or GP diagnosis of chronic obstructive pulmonary disease. 3. 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. 4. Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta2-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. 5. Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 2 or within five half-lives (t½) of the prior investigational study (whichever is longer of the two), (if unsure discuss with the medical monitor prior to screening) 6. Chronic user of systemic corticosteroids: A subject who, in the opinion of the GP/Investigator, is considered to be a chronic user of systemic corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening) 7. Subjects who are using LABA without an ICS as asthma maintenance therapy. 8. 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. 9. 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 of fluticasone furoate(FF)/vilanterol (VI) Inhalation Powder (FF 100mcg/VI 25mcg or FF 200mcg/VI 25mcg) with usual asthma maintenance therapy over twelve months in a large UK primary care population of subjects with Asthma. FF/VI will be administered once-daily (QD) via the Novel Dry Powder Inhaler (NDPI). ; Secondary Objective: The secondary objective is to compare the incidence of serious adverse events of pneumonia during the study of fluticasone furoate (FF)/vilanterol (VI) Inhalation Powder (FF 100mcg/VI 25mcg or FF 200mcg/VI 25mcg) with usual asthma maintenance therapy over twelve months. ; Primary end point(s): The primary endpoint is defined as the percentage of subjects who have either an ACT total score of = 20 or an increase from baseline of = 3 in ACT total score at Week 24 (6th month) assessment. ;Timepoint(s) of evaluation of this end point: Week 24 (Visit 4, Month 6) of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will include; • Percentage of subjects with asthma control (ACT total score = 20) at Weeks 12, 24, 40 and 52. • Mean change from baseline in ACT total score at Weeks 12, 24, 40 and 52. • Asthma-related secondary care contacts 1,2,5,6 • Asthma-related primary care contacts 1,2,3,4 • All secondary care contacts1 • All primary care contacts1, 3 • Mean annual rate of severe asthma exacerbations. A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids 4 (tablets, suspension, or injection) or antibiotics, an inpatient hospitalisation, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics2, 4, 6. •Number of salbutamol inhalers (adjusted to equivalence of 200 actuations) collected by the subjects from study-enrolled community pharmacies over the entire treatment period. •Time to discontinuation or modification of initial therapy (i.e. therapy the subject is randomised to at Visit 2). •Percentage of subjects who have an increase from baseline of = 0.5 in AQLQ(s) total score at Week 52. •Percentage of subjects who have an increase from baseline of = 0.5 in AQLQ(s) environmental stimuli domain score at Week 52. Notes defining secondary endpoints: 1. All contacts are defined as any encounter the subject may have with a doctor or nurse or other healthcare professionals working as part of the NHS (including telephone calls). 2. Contacts with the NHS or hospitalisation are defined as exacerbation-related contacts if these contacts were a direct result of an acute worsening of asthma symptoms. 3. These contacts do not include protocol-defined study-related visits/contacts defined as | — |
Countries
United Kingdom
Contacts
Public ContactClincial Trials Helpdesk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed