Multicentre Post-market Study of Ectoin® Inhalation Solution in Treatment of Asthma.

Overview

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.

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. The baseline measurement will be represented by the mean of the 7 daily values recorded during the run-in period (week 1) and only after the aforesaid 3 days of training. The subject will measure mPEF and ePEF for at least 7 days and complete the patient diary as applicable (also mentioning asthma attack and exacerbation reporting, rescue medication if any). The V2 will be scheduled to respect this period of 7 days minimum for the baseline value of mPEF value. Visit 2 (V2) - (Day 11-D13): EIL07 treatment start. Completion of Paediatric Asthma Quality of Life Questionnaire (PAQLQ), ACQ-7 and Asthma Quality of Life Questionnaire (AQLQ+12) questionnaires as applicable and Fractional exhaled Nitric Oxide (FeNO) assessment. From V2 to V3 patients will have to comply with daily treatment with EIL07, twice daily measurements of peak inspiratory flow, and daily completion of the diary (asthma attack and asthma exacerbation reporting, rescue medication, adverse event/incident linked to EIL07 intake). A Telephone call (D21±2) will be initiated by the study clinics for updates (if any) and to check patient compliance. Visit 3 (V3) - (Day 33- D37): End of Treatment. The end-of-treatment assessment will be the mean of mPEF at end of week 4 along with a repeat of all on-site questionnaires and assessments performed at V2. Completion of PAQLQ, ACQ-7and AQLQ+12 questionnaires and FeNO assessment. \*\*However, no mean will be performed at the visit and will be calculated after the end-of-study to establish the secondary endpoint. From V3 to V4 patients will have to continue to record twice-daily measurements of mPEF and ePEF as well as daily completion of the diary (asthma attack and asthma exacerbation reporting, rescue medication if any) Visit 4 (V4) - (Day 40- Day 45): End of study/end of follow-up. As a follow-up, all applicable PEFs will be repeated/recorded. Completion of ACQ-7 questionnaire and FeNO assessment. The primary endpoint is the change of the mPEF from baseline to the end-of-treatment period (in 3 weeks' time). The Peak Expiratory Flow (applicable for both mPEF and ePEF) is defined as the maximum speed of expiration as measured with the Smart Peakflow (best of 3 measurements) Secondary Endpoints: * Change in weekly mean evening Peak Expiratory Flow (ePEF). * Change in weekly mean morning Peak Expiratory Flow (mPEF). * Evolution of the mean number of days with rescue medication intakes. * Change of quality of life questionnaires, Paediatric Asthma Quality of Life Questionnaire (PAQLQ) score is applicable for children up to 12 years and Asthma Quality of Life Questionnaire (AQLQ+12) is applicable for patients aged 12-years and older * Change of asthma control questionnaire (ACQ-7)

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Outcomes