Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)

Study Overview
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Brief Summary
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The mean objectives are to evaluate the impact of BDP/FF/G fixed combination on health-status and adherence

Official Title
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The Impact on the Health Status and Adherence in a Real-life Setting of Italian Patients With Chronic Obstructive Pulmonary Disease in Treatment With Trimbow® pMDI b.i.d.: a 12-month Prospective Observational Study

Conditions
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COPD

Intervention / Treatment
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* Drug: BDP/FF/G fixed combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent to participate in the study; Adult patients of either sex aged ≥ 40 years; Patients with diagnosis of moderate to very severe COPD according to Gold Initiative for Chronic Obstructive Lung Disease (GOLD) updated 2019 (GOLD Stage 2-4); COPD assessment test (CAT) score ≥ 10 at initiation of BDP/FF/G fixed combination; History of >1 moderate or severe COPD exacerbation during the previous year. Patients in treatment with BDP/FF/G as per local clinical practice and according to Trimbow® Summary of Product Characteristics (SmPC). Exclusion Criteria: According on Investigator's judgement, patients unable to comply with the requirements of the study (e.g. inability to attend all the planned study visits according to the time limits included) or patients with poorly controlled concomitant severe diseases or conditions that could interfere with the study participation; Participation in an interventional clinical trial within 30 days prior to enrolment into the present study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient in treatment with BDP/FF/G fixed combination<br> | Drug: BDP/FF/G fixed combination<br>* Fixed combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium (G).<br>* Other names: Trimbow;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in COPD Assessment Test (CAT) score | CAT consists of 8 items scored on a scale of 1 to 5, with a total score range of 0-40. A higher score denotes a more severe impact of COPD on the patient's life. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in COPD Assessment Test (CAT) score | CAT consists of 8 items scored on a scale of 1 to 5, with a total score range of 0-40. A higher score denotes a more severe impact of COPD on the patient's life. | 6 months | 
| Change in 12-item Test of Adherence to Inhalers (TAI-12) score | TAI comprises a patient domain (including 10 items) and a healthcare professional domain (including 2 items). Each item ranges from 1 (lowest adherence) to 5 (highest adherence) points. The patient domain score ranges from 10 to 50. Adherence is rated as good (score =50), intermediate (score = 46-49), or poor (score ≤45). The questions for healthcare professionals are scored with 1 or 2 points (poor or good knowledge of the regimen and/or inhalation technique). | 6 and 12 months | 
| Change in COPD and Asthma Sleep Impact Scale (CASIS) score | It is a self-administered 7-item scale scored on a five-point scale ranging from 0 if the item never applies, to 4 if the item applies very often. A total raw score is produced from the sum of the seven individual scores which is then linearly transformed to a 0-100 total scale score. Higher scores representing greater sleep deterioration in the previous week. | 6 and 12 months | 
| Change in EuroQoL score | Il consists of 2 pages, a descriptive system and a visual Analogue scale. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.The VAS records the respondent's self-rated health on a 10 cm vertical VAS with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. | 6 and 12 months | 
| Change of an 8-item questionnaire on satisfaction and usability of the device score from baseline (Visit 1) | it contains 8 questions, each scored on a 0-5 Likert scale, which range from 0 (fully disagree) to 5 (fully agree), for a total maximum score of 40. Higher scores indicate a higher ease of use and satisfaction with the inhaler | 6 and 12 months | 
| Forced Expiratory Volume in the first second (FEV1, L) |  | Baseline, 6 and 12 months | 
| Forced Vital Capacity (FVC, L) |  | Baseline, 6 and 12 months | 
| Mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75) | Taken from the test with the highest values of FEV1 and FVC | Baseline, 6 and 12 months | 
| Ratio FEV1/FVC | Derived from these highest values of each parameter | Baseline, 6 and 12 months | 
| Use of rescue medication | Use of rescue medication | Baseline, 6 and 12 months | 
| Exacerbations | Moderate to severe exacerbations | Baseline, 6 and 12 months | 
| Adverse events | Number of adverse events | Baseline, 6 and 12 months | 
| Economic resources consumption | Number of hospitalizations, ER access, unscheduled visits | Baseline, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Adherence, HRQoL determinants