NEXThaleR Real-world Study Assessing the EffectivenesS of BDP/FF/G Fixed triPle cOmbiNation on Symptom scorEs in COPD Patients
- Conditions
- COPD
- Registration Number
- NCT05743608
- Lead Sponsor
- Chiesi Hungary Ltd.
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1336
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method COPD Assessment Test (CAT) 6 months Change in symptom scores (COPD Assessment Test - CAT) after six months of treatment. On a scale of 0-40
- Secondary Outcome Measures
Name Time Method Responders 6 months Percentage of patients with a change from baseline 2\< in CAT after 6 months of treatment compared to baseline (assessment of response to therapy).
Health Related Quality of Life (HRQoL) - questions 6 months 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
Symptoms 6 months To assess changes in frequency of cough and sputum production after 6 months of treatment compared to baseline.
Saturation 6 months To assess changes in arterial oxygenation compared to baseline oxigen saturation (SpO2) after 6 months of treatment.
HRQoL - VAS 6 months 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
Night-time symptoms 6 months To assess changes in the frequency of night-time symptoms after 6 months of treatment compared to baseline.
mMRC 6 months 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
Lung function - Forces Expiratory flow in 1 second (FEV1) 6 months Change in FEV1 values after inhalation during 6 months of treatment compared to baseline.
Lung function Forced Vital Capacity (FVC) 6 months Change in FVC values after inhalation during 6 months of treatment compared to baseline.
Adherence 6 months 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
Trial Locations
- Locations (39)
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
Scroll for more (29 remaining)Albert Schweitzer Kórház és Rendelőintézet Tüdőbeteggondozó🇭🇺Aszód, Hungary