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

Study Overview
=================
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.

Official Title
-----------------
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)

Conditions
-----------------
COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient had been diagnosed with COPD for over a year by a pulmonologists specialist Patients ≥ 35 years of age outpatient Having had a spirometry test performed maximum 1 month prior to inclusion OR on the day of study inclusion Eligibility to Trimbow 88/5/9 µg inhalation powder treatment according to SmPC: having a moderate or severe obstruction (30%≤FEV1<80%) uncontrolled despite fixed dual combination treatment (LABA/LAMA or ICS/LABA): at least 1 severe or 2 moderate exacerbations (requiring hospital admission) in the past 12 months symptomatic patient (CAT≥10 and/or mMRC ≥2) Therapy was changed to Trimbow® 88/5/9 µg inhalation powder maximum 1 week prior to or on the day of study inclusion and irrespective of study entry (escalation of symptomatic patient to fixed triple combination as per treatment protocol) Patient provided informed consent to study participation and related data collected Patient with no functional disability Exclusion criteria: Participation in any clinical trial, 30 days prior to inclusion Ongoing severe exacerbation (requiring hospitalisation) or severe exacerbation within the last 4 weeks Diagnosis of asthma (asthma/COPD co-occurrence - ACO not allowed!) Continuous use of oral corticosteroids or oxygen therapy Patients with other important diseases of the respiratory system or other organ systems that may significantly contribute to COPD symptoms (such as untreated heart failure, symptomatic anaemia, etc.) Any additional contraindications listed in the SmPC for Trimbow® 88/5/9 µg inhalation powder and any other provision in the SmPC that would prevent the patient from receiving fixed triple combination therapy The patient is unable to complete the part of the questionnaire(s) relevant to him/her

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderate to severe COPD patients receiving Trimbow dry powder inhaler<br>Patients above the age of 35 years, who had been diagnosed with COPD for over a year by a pulmonologists specialist. Having a moderate or severe obstruction (30%≤FEV1<80%) and are uncontrolled despite fixed dual combination treatment (LABA/LAMA or ICS/LABA). Therapy was changed to Trimbow® 88/5/9 µg inhalation powder maximum 1 week prior to or on the day of study inclusion and irrespective of study entry (escalation of symptomatic patient to fixed triple combination as per treatment protocol) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COPD Assessment Test (CAT) | Change in symptom scores (COPD Assessment Test - CAT) after six months of treatment. On a scale of 0-40 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function - Forces Expiratory flow in 1 second (FEV1) | Change in FEV1 values after inhalation during 6 months of treatment compared to baseline. | 6 months | 
| Lung function Forced Vital Capacity (FVC) | Change in FVC values after inhalation during 6 months of treatment compared to baseline. | 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). | 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 | 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 | 6 months | 
| Symptoms | To assess changes in frequency of cough and sputum production after 6 months of treatment compared to baseline. | 6 months | 
| Saturation | To assess changes in arterial oxygenation compared to baseline oxigen saturation (SpO2) after 6 months of treatment. | 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 | 6 months | 
| Night-time symptoms | To assess changes in the frequency of night-time symptoms after 6 months of treatment compared to baseline. | 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 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAT, COPD, Fixed-dose triple inhaled therapy