Multicentre Post-market Study of Ectoin® Inhalation Solution in Treatment of Asthma. (NCT05699941) | Clinical Trial Compass
CompletedNot Applicable
Multicentre Post-market Study of Ectoin® Inhalation Solution in Treatment of Asthma.
Poland204 participantsStarted 2023-01-13
Plain-language 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.
Who can participate
Age range6 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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)
Exclusion criteria
✕0. Treatment with Ectoin® for respiratory conditions (in past 8 weeks)
✕1. Pregnant or breastfeeding women
✕2. Participation in any other clinical study within the last 4 weeks prior to screening.
✕3. Experienced a respiratory tract infection in the 4 weeks prior to Visit 1.