An Observational Prospective Study to Characterize Patients Initiating Enerzair® Breezhaler®, With or Without Sensor, as a Maintenance Treatment for Asthma

Study Overview
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Brief Summary
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This is an observational, descriptive, open-label, prospective, 6-month study including a group of patients with a first prescription of IND/GLY/MF with sensor and a group with a first prescription of IND/GLY/MF without sensor.

Detailed Description
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Patients will be invited prospectively and sequentially to participate in the study when attending a participating community pharmacy with a first prescription of IND/GLY/MF with sensor or IND/GLY/MF without sensor. Therefore, the invitation for the patient to participate in the study will occur only after the therapeutic decision has taken place

Official Title
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Sensor: ENhancing aSthma carE - An Observational Prospective Study to Characterize Patients Initiating Indacaterol + Glycopyrronium Bromide + Mometasone Furoate (Enerzair® Breezhaler®), With or Without Sensor, as a Maintenance Treatment for Asthma

Conditions
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Asthma

Intervention / Treatment
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* Other: IND/GLY/MF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged ≥18 years Self-reported diagnosis of asthma Individual filling a first prescription of IND/GLY/MF with or without sensor in a participating community pharmacy for himself/herself (excluding caregivers). Individual capable and willing to perform the study assessments. Exclusion Criteria: No exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| IND/GLY/MF with sensor<br>Patients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate with sensor | Other: IND/GLY/MF<br>* Prospective observational cohort study. There is no treatment allocation. Patients will be invited to participate in the study when attending participating community pharmacies with a first prescription of IND/GLY/MF with sensor or IND/GLY/MF without sensor<br>* Other names: Enerzair® Breezhaler®;|
| IND/GLY/MF without sensor<br>Patients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate without sensor | Other: IND/GLY/MF<br>* Prospective observational cohort study. There is no treatment allocation. Patients will be invited to participate in the study when attending participating community pharmacies with a first prescription of IND/GLY/MF with sensor or IND/GLY/MF without sensor<br>* Other names: Enerzair® Breezhaler®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline sociodemographic - living status | Assess if the patient lives alone: Yes No Don't know/ Don't answer | Baseline | 
| Baseline sociodemographic - household income | Patient's household net income level: <665 € [665€ to 1000€[ [1000€ to 1200€[ [1400€ to 1700€[ [1700€ to 2000€[ [2000€ to 2700€[ ≥2700€ Don't know/Don't answer | Baseline | 
| Baseline sociodemographic - educational level | Patient's highest completed educational level: None I - Basic education (4 years) II - Basic education (6 years) III - Basic education (9 years) Upper secondary education or equivalent (12 years) Bachelor/ University Degree Don't know/Don't answer | Baseline | 
| Baseline sociodemographic - employment status | Patient Employment status: Employed. Number of hours per week. Unemployed Student Retired Other. Specify. Don't know/Don't answer | Baseline | 
| clinical characteristics - body mass index | body mass index will be provided | Baseline | 
| clinical characteristics - smoking status | Patient smoking status: Never smoked Ex-smoker Smoker Don't know/Don't answer | Baseline | 
| clinical characteristics - comorbidities | Patient comorbidities: Allergic rhinitis Rhinosinusitis Allergic conjunctivitis Sleep disorders Anxiety Depression Other. Specify | Baseline | 
| clinical characteristics - duration of disease | duration of disease will be provided | Baseline | 
| clinical characteristics - age at asthma diagnosis | Age when asthma was diagnosed: Years Unknown/cannot remember | Baseline | 
| clinical characteristics - asthma-related hospitalizations | Number of hospitalizations: n of hospitalizations Don't know/Don't answer | Baseline | 
| clinical characteristics - emergency admissions and non-scheduled visits in the previous 12 months | Number of appointments: number of scheduled asthma physician's appointments number of unscheduled asthma physician's appointments Don't know/Don't answer | Baseline | 
| clinical characteristics - ACT score | The Asthma Control Test (ACT) contains 5 questions that are related to the frequency of both asthma symptoms and required rescue medication use during the previous 4 weeks. The scores in the ACT range from 5 (worse control) to 25 (total control) | Baseline | 
| clinical characteristics - TAI score | The TAI questionnaire was developed to measure self-reported adherence to inhaler devices and help clinicians to evaluate non-adherence barriers related to inhaled therapy in adult patients with asthma or chronic obstructive pulmonary disease. The interpretation of adherence based on the 10-item TAI, scoring is that an overall score of 50 points highlights good adherence, while a score of between 46 to 49 points denotes intermediate adherence. A total score ≤ 45 points indicates poor adherence | Baseline | 
| clinical characteristics - last asthma treatment | International Nonproprietary Name (INN) of Last asthma medication | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in self-reported adherence - TAI questionnaire score | The TAI questionnaire was developed to measure self-reported adherence to inhaler devices and help clinicians to evaluate non-adherence barriers related to inhaled therapy in adult patients with asthma or chronic obstructive pulmonary disease. The interpretation of adherence based on the 10-item TAI, scoring is that an overall score of 50 points highlights good adherence, while a score of between 46 to 49 points denotes intermediate adherence. A total score ≤ 45 points indicates poor adherence | Baseline, month 3, month 6 | 
| Changes from baseline in self-reported adherence - asthma control test (ACT) score | The Asthma Control Test (ACT) contains 5 questions that are related to the frequency of both asthma symptoms and required rescue medication use during the previous 4 weeks. The scores in the ACT range from 5 (worse control) to 25 (total control) | Baseline, month 3, month 6 | 
| Adherence from the app (percentage) | Adherence over last month to be measured using a scale from 0 to 100 | Month 3, month 6 | 
| Asthma control from the app (category) | Asthma control over last month: Well controlled Not properly controlled Poorly controlled Unknown | Month 3, month 6 | 
| Rescue medication from the app | Rescue medication over last month (n days): N days N days over the night period | Month 3, Month 6 | 
| Percentage of patients in treatment | Percentage of patients in treatment will be provided | month 3, month 6 | 
| Reasons for discontinuation and treatment switch | Reason for treatment discontinuation: Tolerability Loss of efficacy Price Problems with medication use Following emergency/ hospitalization Condition improved Other. Specify. Don't know/Don't answer | month 3, month 6 | 
| Change from baseline in number of hospitalizations | Number of hospitalizations and nights: n of hospitalizations n of nights Don't know/Don't answer | Baseline, month 3, month 6 | 
| Change from baseline in number of emergency room visits | Number of emergency room visits: n (visits) Don't know/don't answer | Baseline, month 3, month 6 | 
| Change from baseline in number of scheduled and non-scheduled medical visits | Number of appointments: n of scheduled appointments n of unscheduled appointments Don't know/ Don't answer | Baseline, month 3, month 6 | 
| Change from baseline in number of work hours/days missed | How many hours/days the patient missed work or was delayed: n (days) Not applicable | Baseline, month 3, month 5 | 
| Percentage of patients by level of treatment satisfaction | Treatment satisfaction: Very satisfied Satisfied Not Satisfied/unsatisfied Unsatisfied Very Unsatisfied | month 3, month 6 | 
| Percentage of patients who downloaded the app in the group of IND/GLY/MF with sensor. | Patient downloaded the app: Yes No | month 3, month 6 | 
| percentage of patients with a valid app report in the group of IND/GLY/MF with sensor. | Number of patients that downloaded the app | month 3, month 6 | 
| percentage of patients reporting ease to use and understand how to use the sensor and the app in the group of IND/GLY/MF with sensor | Ease to use the app/sensor: Yes No Don't know/Don't answer | month 3, month 6 | 
| percentage of patients reporting usefulness of the sensor/app reports in asthma control and treatmen in the group of IND/GLY/MF with sensor.t | Usefulness of the app report in learning about their asthma: Yes No Don't know/Don't answer | month 3, month 6 | 
| Percentage of patients with desire to continue using sensor/app in the group of IND/GLY/MF with sensor. | Desire to continue using the app: Yes No Don't know/Don't answer | month 3, month 6 | 
| Percentage of patients with fair acquisition value for sensor/app in the group of IND/GLY/MF with sensor | Fair acquisition value of sensor/app: 0 € 1 to 5 € 6 to 10€ 11 to 15 € 16 to 20 € More than 20 € | month 3, month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, SENSE study, Enerzair, Breezhaler, maintenance treatment