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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,336
COPD Assessment Test (CAT)
Change in symptom scores (COPD Assessment Test - CAT) after six months of treatment. On a scale of 0-40
Time frame: 6 months
Lung function - Forces Expiratory flow in 1 second (FEV1)
Change in FEV1 values after inhalation during 6 months of treatment compared to baseline.
Time frame: 6 months
Lung function Forced Vital Capacity (FVC)
Change in FVC values after inhalation during 6 months of treatment compared to baseline.
Time frame: 6 months
Responders
Percentage of patients with a change from baseline 2\< in CAT after 6 months of treatment compared to baseline (assessment of response to therapy).
Time frame: 6 months
Health Related Quality of Life (HRQoL) - questions
To assess changes in quality of life in EQ-5D-3L domains after 6 months of treatment compared to baseline. Scale on a level of three
Time frame: 6 months
HRQoL - VAS
To assess changes in quality of life in EQ-5D visual analogue scale (VAS) after 6 months of treatment compared to baseline. Scale from 0-100
Time frame: 6 months
Symptoms
To assess changes in frequency of cough and sputum production after 6 months of treatment compared to baseline.
Time frame: 6 months
Saturation
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Albert Schweitzer Kórház és Rendelőintézet Tüdőbeteggondozó
Aszód, Hungary
Bajai Szent Rókus Kórház, Tüdőbeteggondozó Intézet
Baja, Hungary
National Korányi Institute of Pulmonology
Budapest, Hungary
Bajcsy -Zsilinszky Kórház és Rendelőintézet
Budapest, Hungary
Józsefvárosi Szent Kozma Egészségügyi Központ Tüdőgyógyászat és Gondozó
Budapest, Hungary
Kispesti Egészségügyi Intézet Tüdőgondozó, Ernyőképszűrő állomás
Budapest, Hungary
Szent Kristóf Szakrendelő Tüdőgondozó
Budapest, Hungary
Toldy Ferenc Kórház és Rendelőintézet I. Tüdőgondozó
Cegléd, Hungary
Csornai Margit Kórház Tüdőbeteggondozó Intézet
Csorna, Hungary
Debreceni Egyetem Klinikai Központ, Kenézy Gyula Campus Pulmonológiai részleg
Debrecen, Hungary
...and 29 more locations
To assess changes in arterial oxygenation compared to baseline oxigen saturation (SpO2) after 6 months of treatment.
Time frame: 6 months
Adherence
To assess changes in adherence to inhaler treatment according to the TAI (Test of adherence to inhalers) questionnaire after 6 months of treatment compared to baseline. Scale is from 12-54
Time frame: 6 months
Night-time symptoms
To assess changes in the frequency of night-time symptoms after 6 months of treatment compared to baseline.
Time frame: 6 months
mMRC
To assess changes in dyspnoea severity using the mMRC (modified Medical Research Council) questionnaire after 6 months of treatment compared to baseline. Scale from 1-4
Time frame: 6 months