Efficacy of Ectoin® Inhalation Solution EIL07 as Supportive Treatment for Children and Adult With Mild to Moderate Asthma: a Post-Market Clinical Follow-up (PMCF) Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 204
- 试验地点
- 10
- 主要终点
- Change in Morning Peak Expiratory Flow
研究概览
简要总结
The goal of this multi-centre, prospective, open-label, single-arm, post-market clinical follow-up study is to further strengthen the already existing clinical evidence for supportive treatment and symptoms alleviation in asthma by evaluating the clinical efficacy of Ectoin® Inhalation Solution in paediatric and adults patients with mild to moderate asthma.
详细描述
A multi-centre, prospective, open-label, post-market follow-up study according to Article 61 and Part-B Annex XIV Medical Device Regulation (MDR 2017/745) and conforming to International Organization for Standardization - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020) requirements.
Study participation will be offered to patients with clinically diagnosed Asthma for which the Ectoin Inhalation Solution is indicated. The enrollment will be subject to an invitation by the investigators of the study sites among their paediatric and adult outpatients coming in for the consultation about asthma. Participation in the study will be, however, based on compliance with all the inclusion criteria and subsequent signed informed consent (ICF) including assent where applicable.
The duration of participation in the clinical study will be 42±2 days (6 weeks) from enrollment). The clinical investigation comprises 4 visits and 1 telephone call. During the study, Ectoin® Inhalation Solution will be used from Visit V2 onwards until V3 (3 weeks) according to the Instruction for Use (IFU). V3 marks the end-of-treatment. However, a follow-up will be conducted at V4 which will mark the end-of-study/ end-of-follow-up.
Visit 1: (D1): Screening, enrollment and training. The first visit will be used for acquiring ICF as per age requirements. Subsequently, the final screening assessment and training of PEF recording will be performed. Also, the Asthma Control Questionnaire (ACQ-7) to be filled out by enrolled patients on the day.
Minimum 3 days of training following V1 the morning Peak Expiratory Flow (mPEF) is to be measured in the morning upon awakening before taking any asthma controller/rescue medication. The evening Peak Expiratory Flow (ePEF) is to be measured at bedtime.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged≥ 6 years to 60 (included)
- •A documented clinical history of asthma for a period of at least 6 months
- •Baseline mild to moderate uncontrolled asthma, defined as meeting at least one of the following:
- •Forced Expiratory Volume in 1 Second (FEV1): 60%<FEV1 <95% predicted
- •Asthma Control Questionnaire (ACQ-7): Score ≥1.5
- •In case of routine treatment with Inhaled Corticosteroids (ICS), maintenance therapy for 8 weeks or longer (stable dose ≥4 weeks before screening)
- •Patient who qualifies for EIL07 treatment according to the approved indication and in physician's opinion the participant will benefit from this treatment.
- •Able to use the Smart Peakflow meter (with the help of a caregiver in case of minors, if needed)
- •Signed informed consent from legally designated representatives (for minors) / adult patients
- •Signed assent from minors if applicable
- •Willingness of the participants to actively participate in the study and to come to the scheduled visits.
排除标准
- •Treatment with Ectoin® for respiratory conditions (in past 8 weeks)
- •Pregnant or breastfeeding women
- •Participation in any other clinical study within the last 4 weeks prior to screening.
- •Experienced a respiratory tract infection in the 4 weeks prior to Visit
- •Experienced an acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalisation within 8 weeks of Visit
- •Any use of oral/parenteral corticosteroid within 8 weeks of Visit
- •Surgery to the lower respiratory tract.
- •Hypersensitivity to Ectoin® or any of the other ingredients
结局指标
主要结局
Change in Morning Peak Expiratory Flow
时间窗: Baseline (week 1) upto week 4
Change in mPEF during the treatment period from baseline will be analysed using a model for repeated measurements (MMRM) with time (week), mPEF baseline value and age class (\<12 and ≥12 years) as fixed factors and patient as a random effect. The morning PEF is to be measured in the morning upon awakening before taking any asthma controller/rescue medication. The PEF is defined as the maximum speed of expiration as measured with the Smart Peakflow (best of 3 measurements). The baseline measurement is represented by the mean of the 7 daily values recorded during the run-in period (week 1) and the end-of-treatment measurement is the mean of morning PEF during week 4 (at least 7 days, V3)
次要结局
- Change in Morning/Evening Peak Expiratory Flow(Week 4 to week 5)
- Change Morning PEF(Baseline (week 1) to each treatment week (week 2 and week3))
- Rescue medication(Week 5)
- Change in Evening Peak Expiratory Flow(Baseline (week 1) to week 2, week 3 and week 4)
- FeNO (fractional exhaled nitric oxide) assessment(Week 4 to week 5)
- Change in Asthma control questionnaire (ACQ-7)(Week 4 to week 5)
- Quality of life questionnaire PAQLQ or AQLQ+12(Week 2 upto week 5)