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Enrolling By Invitation
NCT05699941
Multicentre Post-market Study of Ectoin® Inhalation Solution in Treatment of Asthma.
Conditions: Asthma
Sex: All
Ages: 6 Years – 60 Years
Phase: NA
Enrollment: 210
Sponsor: Bitop AG
Location: Poland
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.
Eligibility Criteria
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 monthsBaseline mild to moderate uncontrolled asthma, defined as meeting at least one of the following:Forced Expiratory Volume in 1 Second (FEV1): 60%<FEV1 <95% predictedAsthma Control Questionnaire (ACQ-7): Score ≥1.5In 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 patientsSigned assent from minors if applicableWillingness of the participants to actively participate in the study and to come to the scheduled visits.Exclusion Criteria:Treatment with Ectoin® for respiratory conditions (in past 8 weeks)Pregnant or breastfeeding womenParticipation 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
Source: ClinicalTrials.gov (NCT05699941). StuddyBuddy aggregates publicly available trial information.
