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 Compared With Usual Maintenance Therapy in Subjects With Asthma
Overview
- Phase
- Phase 3
- Intervention
- fluticasone furoate + vilanterol
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 4233
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma. 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.
Detailed Description
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 asthma in a localised geographical region of the UK
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •Informed consent: Subjects must be able to provide informed consent, have their consent signed and dated.
- •Type of subject: Subjects with documented GP diagnosis of asthma as their primary respiratory disease.
- •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
- •Other background asthma medication such as anti-leukotrienes are permitted
- •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
- •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).
- •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
- •Gender and Age: Male or female subjects aged ≥18 years of age at Visit
- •A female is eligible to enter and participate in the study if she is of:
Exclusion Criteria
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •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.
- •COPD Respiratory Disease: A subject must not have current evidence or GP diagnosis of chronic obstructive pulmonary disease.
- •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.
- •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.
- •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)
- •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)
- •Subjects who are using LABA without an ICS as asthma maintenance therapy.
- •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.
Arms & Interventions
FF/VI
fluticasone furoate (FF) + vilanterol (VI) once daily via a Novel Dry Powder Inhaler
Intervention: fluticasone furoate + vilanterol
FF/VI
fluticasone furoate (FF) + vilanterol (VI) once daily via a Novel Dry Powder Inhaler
Intervention: inhaled corticosteroid with or without a long acting beta2-agonist
ICS or ICS/LABA maintenance therapy
inhaled corticosteroid (ICS) alone or in combination with a long acting beta2-agonist (LABA)
Intervention: inhaled corticosteroid with or without a long acting beta2-agonist
Outcomes
Primary Outcomes
Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24.
Time Frame: Baseline (Day 0) and Week 24
The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of \<=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and \>=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The primary efficacy analysis (PEA) Population is defined as all Intent-to-Treat (ITT) participants (that is, all participants who were randomized and received at least one prescription of study medication) who have an ACT total score of \<20 at Baseline (Day 0). The percentage of responders that is participants with an ACT total score \>=20 or an increase from Baseline of \>=3 has been presented
Secondary Outcomes
- Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52.(Weeks 12, 24, 40 and 52)
- Annual Rate of Asthma-related Secondary Care Contacts(Up to Week 52)
- Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.(Weeks 12, 24, 40 and 52)
- Annual Rate of Asthma-related Primary Care Contacts(Up to Week 52)
- Annual Rate of All On-treatment Primary Care Contacts(Up to Week 52)
- Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52.(Baseline (Day 0) and Weeks 12, 40 and 52)
- Number of Participants With Time to First Asthma-related Primary Care Contact(Up to Week 52)
- Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52.(Baseline (Day 0) and Weeks 12, 24, 40 and 52)
- Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.(Baseline (Day 0) and Weeks 12, 24, 40 and 52)
- Number of Participants With Time to First Primary Care Contact(Up to Week 52)
- Time to Modification of Initial Therapy(Up to Week 52)
- Annual Rate of All On-treatment Secondary Care Contacts(Up to Week 52)
- Mean Annual Rate of Severe Asthma Exacerbations(Up to Week 52)
- Percentage of Participants Who Have an Increase From Baseline of >=0.5 in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] Total Score at Week 52.(Baseline (Day 0) and Week 52)
- Percentage of Participants Who Have an Increase From Baseline of >=0.5 in AQLQ(S) Environmental Stimuli Domain Score at Week 52.(Baseline (Day 0) and Week 52)
- Time to First SAE of Pneumonia(Up to Week 52)
- Number of Participants With SAEs(Up to Week 52)
- Time to First Severe Asthma Exacerbation.(Up to Week 52)
- Mean Number of Salbutamol Inhalers Prescribed for Each Participant Over the 12 Month Treatment Period.(Up to 12 months)
- Percentage of Participants With Serious Adverse Event (SAE) of Pneumonia(Up to Week 52)
- Number of Participants With Fatal SAEs of Pneumonia(Up to Week 52)
- Number of Participants With Adverse Drug Reactions (ADRs)(Up to Week 52)