AsthmaEIL-ASTNCT05699941
Multicentre Post-market Study of Ectoin® Inhalation Solution in Treatment of Asthma.
A study testing Ectoin® Inhalation Solution in people with Asthma, run by Bitop AG at 5 sites in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Ectoin® Inhalation Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 5 sitesPoland
- Study dates
- 13 Jan 2023to 25 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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.
Who cannot join
- 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 1.
- Experienced an acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalisation within 8 weeks of Visit 1.
- Any use of oral/parenteral corticosteroid within 8 weeks of Visit 1.
- Surgery to the lower respiratory tract.
- Hypersensitivity to Ectoin® or any of the other ingredients
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
Site 5
Bialystok, 15-430
Site 1
Lublin, 20-095
Site 4
Poznan, 61-578
Site 2
Rzeszów, 35-612
Site 3
Warsaw, 04-314
About this study
Official title: 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.
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.
Read the detailed description
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)
- Conditions
- Asthma
- Being tested
- Ectoin® Inhalation Solution
- Keywords
- Asthma in children, Asthma in adults
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ectoin® Inhalation SolutionDevice
Ectoin Inhalation Solution (Class-IIa Medical Device Directive (MDD) legacy medical device) is an isotonic, aqueous solution containing Ectoin 1.3 % and sea salt 0.6%. It is used for moistening the lung epithelium by the Ectoin hydro complex and supports the barrier function of the lung epithelium. The inhalation solution can be administered with jet, mesh, and ultrasound nebulizers.
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Ectoin® Containing Inhalation Solution (EIL07) (Class-IIa MDD legacy medical device).
Taken twice daily over the period of 3 weeks (treatment) Inhalation of the content of EIL07 single dose (2.5 mL) by using a mesh nebulizer device. Receives: Device: Ectoin® Inhalation Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Morning Peak Expiratory Flow
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)
Measured: Baseline (week 1) upto week 4
Secondary outcomes (10)
Change in Evening Peak Expiratory Flow
Change in weekly mean evening peak expiratory flow (PEF). The evening PEF is to be measured in the evening at bedtime.
Measured: Baseline (week 1) to week 2, week 3 and week 4
Change in Morning/Evening Peak Expiratory Flow
Change in weekly mean evening peak expiratory flow (PEF). The evening PEF is to be measured in the evening at bedtime.
Measured: Week 4 to week 5
Change Morning PEF
Change in weekly mean morning peak expiratory flow (PEF). The morning PEF is to be measured in the morning upon awakening before taking any asthma controller/rescue medication.
Measured: Baseline (week 1) to each treatment week (week 2 and week3)
Rescue medication
Evolution of the mean number of days with rescue medication
Measured: Baseline (week 1) upto week 4
Rescue medication
Evolution of the mean number of days with rescue medication follow-up.
Measured: Week 5
FeNO (fractional exhaled nitric oxide) assessment
Change of fractional exhaled nitric oxide for a sub-group of patients performed on-site over study visit at selected study sites.
Measured: Baseline (week 1) upto week 4
FeNO (fractional exhaled nitric oxide) assessment
Change of fractional exhaled nitric oxide for a sub-group of patients performed on-site over study visit at selected study sites follow-up.
Measured: Week 4 to week 5
Quality of life questionnaire PAQLQ or AQLQ+12
Change of quality of life assessed by the change of Paediatric Asthma Quality of Life Questionnaire score for children up to 12 years (PAQLQ) and by change of the Asthma Quality of Life Questionnaire for patients 12-year-old and older (AQLQ+12) score for adolescent and adult patients.
Measured: Week 2 upto week 5
Change in Asthma control questionnaire (ACQ-7)
Change of asthma control questionnaire (ACQ-7) Mean scores of <= 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma).
Measured: Baseline (week 1) upto week 4
Change in Asthma control questionnaire (ACQ-7)
Change of asthma control questionnaire (ACQ-7) follow-up Mean scores of <= 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma).
Measured: Week 4 to week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start13 Jan 2023
- Primary completion16 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrzej EMERYK, MD, PhD, Principal investigator, Alergotest, Lublin, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699941
- Sponsor's protocol ID
- btph-046-2021-EIL07
- Acronym
- EIL-AST
- Status last verified
- Jun 2024
- First submitted
- 16 Dec 2022
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05699941
- Acronym / sponsor ID
- EIL-AST / btph-046-2021-EIL07
- Conditions
- Asthma
- Keywords
- Asthma in children, Asthma in adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Device: Ectoin® Inhalation SolutionEctoin® Containing Inhalation Solution (EIL07) (Class-IIa MDD legacy medical device). Taken twice daily over the period of 3 weeks (treatment) Inhalation of the content of EIL07 single dose (2.5 mL) by using a mesh nebulizer device. |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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 1.
- Experienced an acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalisation within 8 weeks of Visit 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ectoin® Inhalation SolutionEctoin Inhalation Solution (Class-IIa Medical Device Directive (MDD) legacy medical device) is an isotonic, aqueous solution containing Ectoin 1.3 % and sea salt 0.6%. It is used for moistening the lung epithelium by the Ectoin hydro complex and supports the barrier function of the lung epithelium. The inhalation solution can be administered with jet, mesh, and ultrasound nebulizers. | Device | treatment arm |
Primary outcome
Change in Morning Peak Expiratory Flow
Time frame: 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)
10 secondary outcomes
Change in Evening Peak Expiratory Flow
Time frame: Baseline (week 1) to week 2, week 3 and week 4
Change in Morning/Evening Peak Expiratory Flow
Time frame: Week 4 to week 5
Change Morning PEF
Time frame: Baseline (week 1) to each treatment week (week 2 and week3)
Rescue medication
Time frame: Baseline (week 1) upto week 4
Rescue medication
Time frame: Week 5
FeNO (fractional exhaled nitric oxide) assessment
Time frame: Baseline (week 1) upto week 4
FeNO (fractional exhaled nitric oxide) assessment
Time frame: Week 4 to week 5
Quality of life questionnaire PAQLQ or AQLQ+12
Time frame: Week 2 upto week 5
Change in Asthma control questionnaire (ACQ-7)
Time frame: Baseline (week 1) upto week 4
Change in Asthma control questionnaire (ACQ-7)
Time frame: Week 4 to week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrzej EMERYK, MD, PhD principal investigator
Alergotest, Lublin, Poland
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ectoin® Inhalation Solution in people with Asthma, run by Bitop AG at 5 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Morning Peak Expiratory Flow (time frame: Baseline (week 1) upto week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.