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Real-World Study of Fixed Triple Inhaler Therapy Trimbow 17259 g Assessing Symptom Improvement in Adults with Uncontrolled Asthma

Led by Chiesi Hungary Ltd. · Updated on 2024-11-22

800

Participants Needed

45

Research Sites

43 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the real-world effectiveness of a fixed triple inhaled combination treatment called Trimbow 17259 cg pMDI in patients with asthma. This treatment combines beclometasone dipropionate, formoterol fumarate, and glycopyrronium to improve symptom scores and quality of life. The study focuses on patients with severe asthma who have uncontrolled symptoms despite previous treatments, aiming to understand which asthma types benefit most from this therapy. The study is a multicenter, national, non-interventional, prospective trial enrolling about 800 patients who have already been switched to Trimbow by their pulmonologist. Patients will receive two inhalations twice daily of the fixed triple combination. Data will be collected at four visits enrollment, one month, six months, and twelve months after starting the treatment. Researchers will observe treatment effects during routine clinical care without altering prescribed therapies unless medically necessary. Participants will attend regular outpatient visits where demographic data, medical history, asthma control tests, lung function, quality of life questionnaires, and treatment adherence will be recorded. Use of rescue medications and prescription refills may also be monitored. The main measure is the Asthma Control Test score after six months. Additional assessments include lung function, adherence, and health-related quality of life. Long-term follow-up at twelve months will evaluate exacerbation rates. The study will conclude by August 31, 2027.

CONDITIONS

Brief Title

Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life Setting

Research Team

A

András Keglevich, Dr.

B

Balázs Sánta, Dr.

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