Effectiveness of Extrafine BDP/FF/G Single Inhaler Triple Therapy on Asthma Symptoms Over 6 Months in a Real-World Setting

What this Trial Is About

Researchers are evaluating the real-world effectiveness of a fixed triple inhaled combination therapy called Trimbow 172/5/9 g pMDI in adults with asthma. This study focuses on patients with severe asthma who have been treated for at least three years but still have uncontrolled symptoms despite using other inhaled therapies. The research aims to assess improvements in asthma symptom scores over six months after switching to Trimbow, as well as treatment adherence and lung function. The study is a multicenter, national, prospective, non-interventional design where patients are observed after their doctors independently decide to switch their inhaled therapy to Trimbow 172/5/9 g pMDI. The recommended dose is two inhalations twice daily. Participants will be followed for six months, with assessments at enrollment, one month, and six months. If their asthma treatment changes away from Trimbow during the study, they are excluded. Other asthma medications and reliever inhalers are allowed as usual. Participants will attend three visits during routine clinical care where researchers will collect information on demographics, medical history, asthma control test (ACT) scores, lung function (if available), medication adherence using a questionnaire, and any changes in asthma treatment. The main measure is the change in ACT score over six months. Secondary measures include lung function improvement and adherence to treatment. Safety and treatment changes are monitored throughout the study, which is expected to run from November 2024 to June 2026.

Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)