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

NCT05699941 | Completed DMC

• 1 other identifier: btph-046-2021-EIL07
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 5

Brief 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 adults patients with mild to moderate asthma.

Conditions

Asthma

Keywords

Asthma in children; Asthma in adults

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline (week 1) upto week 4

Secondary Outcomes (10)

• Change in Evening Peak Expiratory Flow

  Baseline (week 1) to week 2, week 3 and week 4

• 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

  Baseline (week 1) upto week 4

• Rescue medication

  Week 5

Study Arms (1)

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.

Device: Ectoin® Inhalation Solution

Interventions

Ectoin® Inhalation Solution DEVICE

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.

treatment arm

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (5)

Site 5

Bialystok, 15-430, Poland

Location

Site 1

Lublin, 20-095, Poland

Location

Site 4

Poznan, 61-578, Poland

Location

Site 2

Rzeszów, 35-612, Poland

Location

Site 3

Warsaw, 04-314, Poland

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Andrzej EMERYK, MD, PhD

  Alergotest, Lublin, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 26, 2023
• Study Start: January 13, 2023
• Primary Completion: October 16, 2023
• Study Completion: October 25, 2023
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5)