Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (NCT06786767) | Clinical Trial Compass
CompletedNot Applicable
Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting
Bulgaria281 participantsStarted 2025-02-01
Plain-language summary
The mainstay of asthma treatment are ICSs, mostly and usually combined with LABA. In the past decade LAMA had been accepted as an add-on treatment for patients on GINA treatment Steps 4 and 5. Recently, RCTs proved the efficacy and safety of fixed triple combinations of moderate and high dose of ICS and LABA, LAMA in a very selected asthmatic population, resulting in the market authorization of these products. However, there is a lack of evidence on the real-world effectiveness of these therapies, especially with regards to improvement in symptom scores and quality of life.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Physician-confirmed clinical diagnosis of asthma according to GINA guidelines and treated for at least 3 years before inclusion
✓. Patients ≥ 18 years of age in ambulatory care
✓. Patients who are eligible for the use of Trimbow 172/5/9 μg pMDI according to the SmPC
✓. patients who experienced one or more asthma exacerbation in the previous year AND
✓. 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).
Exclusion criteria
✕. Participation in any clinical trial within 30 days prior to enrolment
✕. Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment.