MedTrace Logo

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

NCT05699941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2024-06-20

No results posted yet for this study

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

Interventions

DEVICE

Ectoin® Inhalation Solution

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.

Sponsors & Collaborators

  • Bitop AG

    lead INDUSTRY

Principal Investigators

  • Andrzej EMERYK, MD, PhD · Alergotest, Lublin, Poland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-13
Primary Completion
2023-10-16
Completion
2023-10-25

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05699941 on ClinicalTrials.gov