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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Asthma
• Intervention / Treatment: Other: IND/GLY/MF

Detailed Description

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

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a first prescription of IND/GLY/MF with sensor and a group of patients with a first prescription of IND/GLY/MF without sensor at a community pharmacy setting.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IND/GLY/MF with sensor; Patients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate with sensor	Other: IND/GLY/MF; 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; Other Names: Enerzair® Breezhaler®
IND/GLY/MF without sensor; Patients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate without sensor	Other: IND/GLY/MF; 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; Other Names: Enerzair® Breezhaler®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2022
• Primary Completion (Anticipated): May 15, 2023
• Study Completion (Anticipated): May 15, 2023

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Asthma; maintenance treatment; Breezhaler; Enerzair; SENSE study
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CQVM149BPT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO