NCT05743608

NEXThaleR Real-world Study Assessing the EffectivenesS of BDP/FF/G Fixed triPle cOmbiNation on Symptom scorEs in COPD Patients

Non-interventional, Open-label, Prospective Study to Assess the Effectiveness of BDP/FF/G Fixed Triple Inhalation Powder on Symptom Scores in Moderate to Severe COPD Patients, Uncontrolled With Inhaled Dual Therapies (LABA/LAMA or ICS/LABA)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,336 (actual)
• Sponsor: Chiesi Hungary Ltd. · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to measure improvement in health related quality of life in moderate to severe COPD patients treated with Trimbow inhalation powder. The main question\[s\] it aims to answer are: * Treatment's effect on quality of life * Treatment's effect on lung function Participants will be assessed according to routine clinica practice, without any additional intervention.

Detailed description

COPD is a severe and very common disease affecting a large proportion of smokers (and even non-smokers) all around the world. With the large prevalence and wide spectrum of disease presentation (from limited obstruction to life threatening conditions) there is a need for differentiated, targeted approach to therapy. For this purpose, plenty of inhaler devices had been developed. Chiesi is the only company which provides fix triple combinations in both DPI and pMDI formulations. While there is ample data from multiple studies on the real-world effectiveness of the pMDI, there is a relevant gap in our knowledge on the RWE effectiveness of the DPI device Trimbow dry powder inhaler is a novel extrafine, single inhaler triple therapy, in a state of the art dry powder inhaler, which is easy to use and may provide additional benefit to a large proportion of COPD patients. However, there are only a limited number of studies assessing its effectiveness, especially in patients with moderate airflow obstruction. Providing more real-world evidence that Trimbow® dry powder inhaler is an effective and preferred treatment option in reducing symptoms and improving lung function in all COPD patients, would help pulmonologists choose the most suitable treatment option for a very wide array of patients.

Conditions

• COPD

Timeline

• Start date: 2023-03-29
• Primary completion: 2024-10-31
• Completion: 2025-05-05
• First posted: 2023-02-24
• Last updated: 2025-09-09

Locations

39 sites across 1 country: Hungary