An Exploratory, Double-blind, Randomised, Multicenter, Psychopharmacological Study in Adult Patients With Moderate to Severe Asthma to Compare Two Pressurised Metered-Dose Inhalers (pMDIs) on Patients' Perception of Asthma Symptoms
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 20
- 主要终点
- Change from baseline in rescue medication use
研究概览
简要总结
The CLI-01535AA02-2 Study is an exploratory study designed to compare two pressurised metered Dose inhalers on subject's perception of asthma symptoms.
详细描述
Outpatients attending the hospital clinics/study centers will be recruited. Moderate to severe asthma adult subjects will be recruited. A total of 75 subjects will be enrolled. The whole study will last approximately 6 weeks for each subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Exploratory, double-blind, randomised, multicenter, 2x2 cross-over study
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
- •Subject's and/or subject legal representative's written informed consent obtained prior to any study related procedure.
- •Age: ≥18 and ≤75 years of age.
- •Established diagnosis of permanent asthma for at least 6 months prior to screening/randomisation visit
- •Subject on maintenance therapy treated by Foster® (CHF1535 100/6 µg pMDI) for at least 6 months prior to screening/randomisation visit
- •Asthma Control Test (ACT) ≥ 20 at screening/randomisation visit.
- •Subject must have a cooperative attitude and the ability to be trained to use correctly the diary and answer the Visual Analogue Scale (VAS)
- •Subject willing and able to download the application on their personal electronic device to fill in the study e-diary.
- •Female subject of non-childbearing potential defined as physiologically incapable of becoming pregnant or female subject + male Partner must be willing to use a highly effective birth control method from the signature of the informed consent and until Visit 4
排除标准
- •Pregnant or lactating woman
- •History of 'at risk' asthma
- •Recent exacerbation
- •Non-permanent asthma
- •Asthma requiring more than 1 inhaler for maintenance treatment and more than 1 inhaler for reliever treatment.
- •Asthma requiring use of biologics
- •Respiratory disorders
- •Lower tract respiratory infection
- •Current smoker or ex-smoker with a smoking current use/history of ≥ 10 pack-years
- •Cardiovascular diseases
- •subject with historical or current evidence of uncontrolled concurrent disease such as but not limited to hyperthyroidism, diabetes mellitus or other endocrine disease; haematological disease; autoimmune disorders
- •Alcohol/drug abuse
结局指标
主要结局
Change from baseline in rescue medication use
时间窗: After 14 days of treatment
To be summarised on the "Intention To Treat" set by treatment group by descriptive statistics. Baseline value is defined as the average value (puffs/day) collected during the baseline period.
Percentages of subjects (for questions with categorical outcome) to evaluate patients' perception of inhalers changes at Day 43 (Visit 4)
时间窗: At Day 43 (Visit 4)
Questions covering patients' preference of device and outcome assessments will be reported on the ITT and PP set by treatment group. This analysis will be applied on questions not collected daily. Each question will be analysed separately.
Summary measures (for questions with continuous outcome) to report patients' expectations of their symptoms change at Day 29 (Visit 3)
时间窗: At Day 29 (Visit 3)
Assessed by Visual Analogue Scale (VAS) that ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome. Each question will be analysed separately.
Summary measures (for questions with continuous outcome) to report patients' expectations of their symptoms change at Day 15 (Visit 2)
时间窗: At Day 15 (Visit 2)
Assessed by Visual Analogue Scale (VAS) that ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome. Each question will be analysed separately.
Summary measures (for questions with continuous outcome) to report patients' expectations of their symptoms change at Day 43 (Visit 4)
时间窗: At Day 43 (Visit 4)
Assessed by Visual Analogue Scale (VAS) that ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome. Each question will be analysed separately.
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) score
时间窗: After 14 days of treatment
There are 32 questions in the AQLQ that are divided in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). Answers are done on a 7-point scale (7 = not impaired at all - 1 = severely impaired), with higher scores indicating better quality of life.
Percentages of subjects (for questions with categorical outcome) to evaluate patients' preference of device at Day 43 (Visit 4)
时间窗: At Day 43 (Visit 4)
Questions covering patients' preference of device and outcome assessments will be reported on the ITT and PP set by treatment group. This analysis will be applied on questions not collected daily. Each question will be analysed separately.
Change from baseline in average Visual Analogic Scale score of subjects' perceptions of asthma symptoms after 14 days of treatment
时间窗: After 14 days of treatment
Visual Analogue Scale (VAS) ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome.
Change from baseline in average Visual Analogic Scale score of subjects' perceptions of asthma symptoms after the first 7 days of treatment
时间窗: After the first 7 days of treatment
Visual Analogue Scale (VAS) ranges from 0 to 100. When question refers to symptom improvement, higher score means better outcome. When question refers to symptoms worsening, higher score means worse outcome.
次要结局
- Occurrence of Treatment Emergent Adverse Event (TEAEs), adverse drug reactions (ADRs), severe ADRs, serious ADRs, serious TEAEs (Serious Adverse Events), non-serious TEAEs, severe TEAEs(From date of the first study drug intake unil date of study treatment, or date of death or up to 14 days after date of the last study drug intake, whichever came first)