Effectiveness of BDP/FF/G 172/5/9 Fixed Triple Combination on Symptom Scores in Asthma Patients After 6 Months Treatment
The mainstay of asthma treatment are ICSs, mostly 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 authorisation 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. Also, there is scarcity of data regarding the phenotypes of asthmatics who benefit the most from the use of fixed triple combinations.
• 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
• Uncontrolled asthma according to the physician's clinical assessment despite the use of
‣ LABA - high dose ICS OR
⁃ LABA - high-dose ICS + LAMA multi-inhaler triple therapy for a minimum of three months.
• Patients who are eligible for the use of Trimbow 172/5/9 μg pMDI according to the SmPC and the financing protocol for asthma
‣ At least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months
⁃ Uncontrolled asthma (ACT≤15)
⁃ FEV1\<80% at baseline
• Inhaled asthma therapy was changed to Trimbow 172/5/9 μg pMDI no more than 1 week prior to OR on the day of study inclusion
• Patient provided written, informed consent to study participation