A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Multi-centre Study to Evaluate the Efficacy and Safety of Inhaled Fluticasone Furoate in the Treatment of Persistent Asthma in Adults and Adolescents Not Currently Receiving Inhaled Corticosteroids
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period
研究概览
简要总结
A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids
详细描述
This will be a multi-centre, randomised, placebo controlled (with rescue medication), double-blind, parallel group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period. Subjects failing screening will not be eligible for re-screening. During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom score and rescue albuterol/salbutamol use. At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised to either inhaled Fluticasone Furoate 50 mcg or inhaled placebo. In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms. Subjects will attend 4 on-treatment visits at Visits 3, 4, 5, and 6 (Weeks 2, 4, 8 and 12 respectively). Subjects will receive treatment for 84 days (12 weeks). A follow-up contact will be performed 1-week after completing study medication (Visit 7). Subjects will participate in the study for up to a maximum of 15 weeks (including screening, treatment and follow-up contact).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks before first visit
- •Both genders; females of child bearing potential must be willing to use appropriate contraception during the study
- •Pre-bronchodilator FEV1 of at least 60% predicted
- •FEV1 reversibility of at least 12% and 200mls
- •Current asthma therapy that includes a non-corticosteroid controller and/or short-acting beta agonist
排除标准
- •History of life-threatening asthma exacerbation within the past 10 years
- •Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months
- •Current or recent respiratory infection or current oral candida infection
- •Presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome
- •Known or suspected allergy to study drug or materials
- •Taking another investigational medication or prohibited medication during the study
- •Previous treatment with inhaled fluticasone furoate in a phase II or III study
- •Current smokers or former smokers with significant tobacco exposure
- •Children in Care
研究组 & 干预措施
Fluticasone furoate 50mcg
Inhalation powder delivered by Novel Dry Powder Inhaler
干预措施: Fluticasone furoate 50mcg (Drug)
Placebo
Inhalation powder delivered by Novel Dry Powder Inhaler
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period
时间窗: Baseline and Week 12
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 12 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.
次要结局
- Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 12-week Treatment Period(From Baseline up to Week 12)
- Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 12-week Treatment Period(From Baseline up to Week 12)
- Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period(From Baseline up to Week 12)
- Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period(From Baseline up to Week 12)
- Number of Participants Who Withdrew Due to a Lack of Efficacy During the 12-week Treatment Period(From the first dose of the study medication until Week 12/Early Withdrawal)