Observational Study on Therapy Pathways of Asthamics Treated With ICS/LABA/LAMA Therapy in a Real-world Setting

Study Overview
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Brief Summary
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TriMaximize is a non-interventional study aimed to collect prospective data from asthmatic patients under routine care, for whom their treating physician has decided to prescribe BDP/FF/G (beclomethasone/formoterol/glycopyrronium).

Official Title
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Multicentre, Prospective, Non-interventional Study Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes

Conditions
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Asthma

Intervention / Treatment
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* Drug: BDP/FF/G


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years of age; Patients with confirmed leading diagnosis of asthma with or without concomitant COPD; Physician decision to start fixed triple therapy with ICS/LABA/LAMA (BDP/FF/G) MS or HS according to its current authorised indication and current reimbursement conditions within the Italian National Health System. The treatment decision must be made independently from participation in this study and may have started within the previous 4 weeks (maximum); Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study. Exclusion Criteria: Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.

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 |
| --- | --- |
| Asthma patients<br>Adult patients with a diagnosis of moderate to severe asthma treated with BDP/FF/G medium strength or high strength as per clinical practice. | Drug: BDP/FF/G<br>* BDP/FF/G is an extrafine single inhaler triple therapy available in two dosage strengths: Medium strength (MS) containing 100 µg of beclomethasone dipropionate, 6 µg of formoterol fumarate dihydrate and 10 µg of glycopyrronium (as 12.5 µg glycopyrronium bromide); High strength (HS) containing 200 µg of beclomethasone dipropionate, 6 µg of formoterol fumarate dihydrate and 10 µg of glycopyrronium (as 12.5 µg glycopyrronium bromide).<br>* Other names: Trimbow;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient demographics |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of asthma control using Asthma Control Test (ACT) | Change from baseline in ACT scores. The ACT is a self-report questionnaire with scores ranging from 5-25 (higher is better). Scores of 20-25 are classified as well-controlled; 16-19 as not well-controlled; and 5-15 as very poorly controlled asthma. The minimum clinically important difference is considered to be 3 point. | 12 months | 
| Assessment of quality of life using Mini Asthma Quality of Life Questionnaire (Mini AQLQ) | Change from baseline in MiniAQLQ scores. The MiniAQLQ is a disease specific questionnaire that consists of 15 asthma-related questions. Participants respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated better quality of life. A change in the score greater than 0.5 can be considered clinically important. | 12 months | 
| Assessment of adherence to treatment using 12-item Test of Adherence to Inhalers (TAI-12) | Change from baseline in TAI-12 score. The 12-item TAI comprises a patient domain (10 items) and a healthcare professional domain (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). | 12 months | 
| Incidence of asthma exacerbations | Number of exacerbations | 12 months | 
| Asthma exacerbations | Occurrence of asthma exacerbations | 12 months | 
| Adverse events | Number of AEs | 12 months | 
| Adverse drug reactions to BDP/FF/G | Number of ADRs | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Triple Therapy, Beclomethasone, Formoterol, Glycopyrronium, Real-world, Single-Inhaler, Quality of life, Control of asthma, Adherence