A 12-Week, Randomized, Open-Label, Parallel-Group Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® (160/4.5 and 320/9 mcg) as Compared With SYMBICORT® TURBOHALER® (200/6 and 400/12 mcg) as Treatment for Adult Patients With Asthma (The Easy Low Instruction Over Time [ELIOT] Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 74
- 主要终点
- Stage 1: Percentage of Participants Achieving Device Mastery
研究概览
简要总结
This study is conducted to assess whether training participants on proper use of BF SPIROMAX and Symbicort TURBOHALER will improve their device-handling technique and potentially improve their treatment outcome, that is, better asthma control.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has a diagnosis of asthma in accordance with Global Initiative for Asthma (GINA) criteria as evidenced by a United Kingdom (UK) quality outcome framework approved Read code (UK diagnostic coding system).
- •The participant is receiving step 3 or 4 therapy for asthma as defined by the British Thoracic Society (BTS) guidelines (daily doses of beclomethasone dipropionate [BDP]-equivalent ICS) ≥800 mcg to 2000 μg as part of fixed- or free combinations with long-acting β2-agonists (LABA).
- •If participant is a female of childbearing potential (post-menarche or less than 2 years post-menopausal or not surgically sterile), the participant must be willing to commit to using a medically accepted method of contraception for the duration of study and 30 days after discontinuing study drug.
- •The participant, as judged by the investigator, must be willing and able to understand risks and benefits of study participation to give informed consent and to comply with all study requirements as specified in this protocol for the entire duration of their study participation.
- •The participant is SPIROMAX and TURBOHALER naïve (no use of a SYMBICORT TURBOHALER device in the last 6 months, minimizing carryover from prior device use).
- •If female and of childbearing potential, the participant must have a negative urine pregnancy test.
- •other criteria apply, please contact the investigator for additional information.
排除标准
- •The participant has any clinically significant uncontrolled medical condition (treated or untreated) that, in the judgment of the investigator, will cause participation in the study to be detrimental to the participant.
- •The participant has participated in a Teva-sponsored clinical study with BF SPIROMAX in the last 6 months.
- •The participant is a pregnant, attempting to become pregnant, or breast feeding. (Any woman becoming pregnant during the study will be withdrawn from the study.)
- •The participant has used a clinical trial investigational drug within 1 month before the screening visit.
- •The participant has an ongoing asthma exacerbation or has received OCS and/or antibiotics for a lower respiratory condition (proxy measure for identifying an asthma exacerbation and/or lower respiratory infection, suggestive of altered inspiratory capabilities) in the 2 weeks preceding visit
- •The participant is currently receiving any OCS (including long or short courses).
- •The participant has a significant chronic lower respiratory tract disease other than asthma (for example chronic obstructive pulmonary disease [COPD], cystic fibrosis or interstitial lung disease). Conditions that are not predominant, such as minor degrees of bronchiectasis, are not a reason for exclusion.
- •The participant has a known allergy or severe sensitivity to the constituents of the study drugs (SPIROMAX or TURBOHALER),for example, to lactose or to milk protein.
- •other criteria apply, please contact the investigator for additional information.
研究组 & 干预措施
Stage 2: BF Spiromax
Participants who have currently received 800 to 1000 micrograms (μg) beclomethasone-equivalent inhaled corticosteroid (ICS) per day will receive budesonide/formoterol twice daily using the BF Spiromax 160/4.5 device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax will be 640 μg and 18 μg, respectively. Participants who have currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax will be 1280 μg and 36 μg, respectively.
干预措施: Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX (Drug)
Stage 2: Symbicort Turbohaler
Participants who have currently received 800 to 1000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler will be 800 μg and 24 μg respectively. Participants who have currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler will be 1600 μg and 48 μg respectively.
干预措施: SYMBICORT TURBOHALER budesonide and formoterol fumarate (Drug)
结局指标
主要结局
Stage 1: Percentage of Participants Achieving Device Mastery
时间窗: Baseline (Day 1)
Device mastery was defined as absence of healthcare professional (HCP)-observed errors by the end of Step 3 of a 6-step standardized device training protocol for empty Spiromax compared to empty Turbohaler. The 6 steps of device training protocol were: Step 1 - Intuitive use; Step 2 - Patient information leaflet; Step 3 - Instructional video; Step 4 - HCP tuition; Step 5 - HCP tuition (1st repeat); Step 6 - HCP tuition (2nd repeat).
Stage 2: Percentage of Participants Maintaining Device Mastery
时间窗: Baseline up to Week 12
Maintenance of device mastery was defined as absence of HCP-observed errors after 12 weeks of device use.
次要结局
- Composite Endpoint: Stage 2: Total Number of Observed Errors (Nurse and Technology [Vitalograph Pneumotrac Spirometer])(Baseline up to Week 12)
- Stage 2: Total Number of Handling Errors(Baseline up to Week 12)
- Stage 2: Change in Handling Errors From Stage 1 to Stage 2(Baseline (Day 1), Week 12)
- Stage 2: Number of Participants With Severe Asthma Exacerbations(Week 12)
- Stage 1: Percentage of Participants Achieving Device Mastery by Step 1(Day 1)
- Stage 2: Number of Participants In Pre-specified Treatment Adherence Categories (Assessed by Device Dose Counters)(Baseline up to Week 12)
- Stage 2: Change From Baseline in 6-Item Asthma Control Questionnaire (ACQ) (Excluding Forced Expiratory Volume in 1 Second [FEV1] Question) Score at Weeks 4, 8, and 12(Baseline, Weeks 4, 8, and 12)
- Stage 2: Impact of Maintaining Device Mastery on Asthma Control Questionnaire Score(Baseline Up to Week 12)
- Stage 1: Percentage of Participants Achieving Device Mastery by Step 2(Day 1)
- Stage 1: Number of Nurse-Observed Errors(Day 1)
- Stage 2: Time to First Treatment Failure(Baseline up to Week 12)
- Stage 1: Number of Steps Taken to Achieve Device Mastery(Baseline (Day 1))
- Stage 1: Patient Satisfaction and Preference Questionnaire (PASAPQ) Total Score(Baseline (Day 1))
- Stage 2: Number of Technology-Observed Errors (Vitalograph Pneumotrac Spirometer)(Week 12)
- Stage 2: Change From Baseline in 7-Item ACQ(Baseline, Week 12)
- Stage 2: Impact of Maintaining Device Mastery on Time to Treatment Failure(Baseline Up to Week 12)
- Number of Participants With Adverse Events (AEs)(Baseline up to Week 12)