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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,233
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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 (<147 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).
排除标准
- •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.
研究组 & 干预措施
FF/VI
fluticasone furoate (FF) + vilanterol (VI) once daily via a Novel Dry Powder Inhaler
干预措施: fluticasone furoate + vilanterol (Drug)
FF/VI
fluticasone furoate (FF) + vilanterol (VI) once daily via a Novel Dry Powder Inhaler
干预措施: inhaled corticosteroid with or without a long acting beta2-agonist (Drug)
ICS or ICS/LABA maintenance therapy
inhaled corticosteroid (ICS) alone or in combination with a long acting beta2-agonist (LABA)
干预措施: inhaled corticosteroid with or without a long acting beta2-agonist (Drug)
结局指标
主要结局
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.
时间窗: 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
次要结局
- 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)