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
- 10
- 主要终点
- Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #3
研究概览
简要总结
This study assessed the influence of pink vs. white pressurized metered-dose inhaler (pMDI) actuators on asthma symptoms perception. There was no prespecified primary objective. The following objectives were assessed:
- Change from baseline in average visual analog scale (VAS) score of the perception of asthma symptoms and burden over the first 7 days and all 14 days in each treatment period (Questions 3-6);
- Change from baseline in AQLQ score after 14 days of treatment in each period;
- Summary measures of psychopharmacological aspects (Questions 7-10);
- Patients' preference and perception of the devices (Questions 11-16);
- Change from baseline in reliever medication use over 14 days of treatment in each period (Question 2).
For both treatment periods, "baseline" for the questionnaire data was the 14-day period prior to the first treatment period, and for AQLQ was the value recorded at Visit 2.
详细描述
This was a phase IIIb, exploratory, double-blind, randomised, multicentre, psychopharmacological, 2x2 cross-over study in adult subjects with moderate to severe asthma.
A total of 78 randomised subjects in 10 actives centres were involved. The study focused on the psychopharmacological aspects, particularly on the subjects' preference for the device and on the impact of the device's features on subjects' perception of asthma symptoms. Subjects were informed that the study treatments were the same medication they had received before enrolment as maintenance therapy (i.e. Foster® 100/6 µg pMDI), but with differing device characteristics.
The study lasted approximately 6 weeks for each subject and comprised four visits (Visit [V] 1 to V4), including:
- Two face-to-face clinic visits: V1 (Day 1, screening/randomisation visit) and V4 (Day 43);
- Two remote video contact visits: V2 (Day 15) and V3 (Day 29).
After signing the ICF, subjects were screened at the investigational site during the screening/randomisation visit (V1). On the same day, and after checking all inclusion and exclusion criteria, eligible subjects were randomised to one of two study treatment sequences and followed the study treatment sequence as follows:
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 and autoimmune disorders
- •Alcohol/drug abuse
- •Participation in an investigational trial within the last 30 days (60 days for biologics) or a more appropriate time as determined by the Investigator
- •Contra-indications to Foster® constituted an exclusion criterion
- •History of hypersensitivity to Foster® or any of its components or a history of any other allergy that in the opinion of the Investigator contra-indicated the subject's participation
- •Subject mentally or legally incapacitated or subject accommodated in an establishment as a result of an official or judicial order
- •Blind, colour-blind subject or any other dyschromatopsia
- •Known psychiatric disorders that may have interfered with successful completion of this protocol according to the Investigator's judgment including schizophrenia, bipolar disorders and psychoses.
研究组 & 干预措施
Sequence Inhaler A - Inhaler B (Period 1)
Participants in this group first received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler A (white actuator) for a 14-day treatment period. They were instructed to take two puffs twice daily (morning and evening), for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator.
After completing the first treatment period, participants switched to Inhaler B (pink actuator) for another 14 days. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate + 12 µg Formoterol fumarate.
There was no washout period between treatments, as the crossover design allowed a direct switch from one inhaler to the other without interruption.
干预措施: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A) (Drug)
Sequence Inhaler A - Inhaler B (Period 1)
Participants in this group first received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler A (white actuator) for a 14-day treatment period. They were instructed to take two puffs twice daily (morning and evening), for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator.
After completing the first treatment period, participants switched to Inhaler B (pink actuator) for another 14 days. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate + 12 µg Formoterol fumarate.
There was no washout period between treatments, as the crossover design allowed a direct switch from one inhaler to the other without interruption.
干预措施: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B) (Drug)
Sequence Inhaler B - Inhaler A (Period 2)
Participants in this group first received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler B (pink actuator) for a 14-day treatment period. They were instructed to take two puffs twice daily (morning and evening), for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator.
After completing the first treatment period, participants switched to Inhaler A (white actuator) for another 14-day treatment period. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate + 12 µg Formoterol fumarate.
There was no washout period between treatments, as the crossover design allowed a direct switch from one inhaler to the other without interruption.
干预措施: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A) (Drug)
Sequence Inhaler B - Inhaler A (Period 2)
Participants in this group first received Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg pressurized metered-dose inhaler (CHF1535 100/6 µg pMDI) using Inhaler B (pink actuator) for a 14-day treatment period. They were instructed to take two puffs twice daily (morning and evening), for a total daily dose of 200 µg Beclomethasone dipropionate and 12 µg Formoterol fumarate. The medication was administered as a metered-dose inhalation of a pressurized solution using a standard actuator.
After completing the first treatment period, participants switched to Inhaler A (white actuator) for another 14-day treatment period. The dosage and administration remained identical to the first phase: two puffs twice daily for a total daily dose of 200 µg Beclomethasone dipropionate + 12 µg Formoterol fumarate.
There was no washout period between treatments, as the crossover design allowed a direct switch from one inhaler to the other without interruption.
干预措施: Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B) (Drug)
结局指标
主要结局
Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #3
时间窗: Baseline and Treatment Day 14 within each treatment period
A study-specific questionnaire was developed to evaluate medication use, asthma symptoms, and treatment perception. It consisted of 16 questions, completed by subjects via an e-Diary. Some were answered daily from V1 (Day 2) to V4 (Day 43), others only at V2 (Day 15), V3 (Day 29), and V4 (Day 43). The questionnaire included Visual Analogue Scale (VAS) ratings, numerical responses, and multiple-choice questions, with VAS primarily used to assess symptom perception and psychopharmacological effects. Question #3 (How would you score your asthma symptoms yesterday?) was recorded daily, each morning, from V1 (Day 2) to V4 (Day 43), with subjects rating their asthma symptoms from the previous day on a VAS scale from 0=no symptoms to 100=very symptomatic, with lower scores corresponding to better health. The overall value for each treatment period was defined as the average of the VAS scores collected over the two weeks of treatment within each period. Adjusted means are reported.
次要结局
未报告次要终点