Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT06786767
Eligibility Criteria:
Inclusion Criteria:
1. Physician-confirmed clinical diagnosis of asthma according to GINA guidelines and treated for at least 3 years before inclusion
2. Patients ≥ 18 years of age in ambulatory care
3. Patients who are eligible for the use of Trimbow 172/5/9 μg pMDI according to the SmPC
1. patients who experienced one or more asthma exacerbation in the previous year AND
2. patients not adequately controlled according to the physician's clinical assessment despite the use of b1) LABA and high dose ICS OR b2) LABA and high-dose ICS + LAMA multi-inhaler triple therapy. FEV1\<80% at baseline. (spirometry performed at the visit 1 independently of the study or up to 30 days before the enrolment or within 3 days after Visit 1 is acceptable).
5\. Inhaled asthma therapy was changed to Trimbow 172/5/9 μg pMDI no more than 2 weeks prior to OR on the day of study inclusion 6. Patient provided written, informed consent to study participation
Exclusion Criteria:
1. Participation in any clinical trial within 30 days prior to enrolment
2. Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment.
3. Diagnosis of COPD.
4. Tuberculosis (active or anamnestic)
5. Actual or previous use of biologics for asthma treatment in the past 12 months
6. All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC
7. Hypersensitivity to the active substances or to any of the excipients listed in the SmPC
8. Pregnancy and lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06786767
Study Brief:
Protocol Section:
NCT06786767