A Prospective Non-Interventional Real-world Study Assessing the Effectiveness of Extrafine BDP/FF/G HS Single Inhaler Triple Therapy (SITT) 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 at GINA 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 adherence.
• 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 and high dose ICS or
⁃ LABA and 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 :
‣ at least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months
⁃ uncontrolled asthma (ACT≤15) or partially controlled asthma (15\<ACT\<20)
⁃ 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