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

Withdrawn

• Conditions: Asthma
• Interventions: Other: IND/GLY/MF

• Registration Number: NCT05120986
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-16
• Study Start: 2022-02-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-04
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Read More

Exclusion Criteria

• No exclusion criteria.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IND/GLY/MF without sensor	IND/GLY/MF	Patients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate without sensor
IND/GLY/MF with sensor	IND/GLY/MF	Patients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate with sensor

Primary Outcome Measures

Name	Time	Method
clinical characteristics - asthma-related hospitalizations	Baseline	Number of hospitalizations: * n of hospitalizations; * Don't know/Don't answer
Baseline sociodemographic - educational level	Baseline	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
clinical characteristics - body mass index	Baseline	body mass index will be provided
clinical characteristics - smoking status	Baseline	Patient smoking status: * Never smoked; * Ex-smoker; * Smoker; * Don't know/Don't answer
clinical characteristics - TAI score	Baseline	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 sociodemographic - living status	Baseline	Assess if the patient lives alone: * Yes; * No; * Don't know/ Don't answer
clinical characteristics - comorbidities	Baseline	Patient comorbidities: * Allergic rhinitis; * Rhinosinusitis; * Allergic conjunctivitis; * Sleep disorders; * Anxiety; * Depression; * Other. Specify
clinical characteristics - duration of disease	Baseline	duration of disease will be provided
clinical characteristics - age at asthma diagnosis	Baseline	Age when asthma was diagnosed: * Years; * Unknown/cannot remember
clinical characteristics - emergency admissions and non-scheduled visits in the previous 12 months	Baseline	Number of appointments: * number of scheduled asthma physician's appointments; * number of unscheduled asthma physician's appointments; * Don't know/Don't answer
clinical characteristics - ACT score	Baseline	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)
clinical characteristics - last asthma treatment	Baseline	International Nonproprietary Name (INN) of Last asthma medication
Baseline sociodemographic - household income	Baseline	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 sociodemographic - employment status	Baseline	Patient Employment status: * Employed. Number of hours per week.; * Unemployed; * Student; * Retired; * Other. Specify.; * Don't know/Don't answer

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in self-reported adherence - TAI questionnaire score	Baseline, month 3, month 6	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
Adherence from the app (percentage)	Month 3, month 6	Adherence over last month to be measured using a scale from 0 to 100
Asthma control from the app (category)	Month 3, month 6	Asthma control over last month: * Well controlled; * Not properly controlled; * Poorly controlled; * Unknown
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	month 3, month 6	Ease to use the app/sensor: * Yes; * No; * Don't know/Don't answer
Reasons for discontinuation and treatment switch	month 3, month 6	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
Change from baseline in number of work hours/days missed	Baseline, month 3, month 5	How many hours/days the patient missed work or was delayed: * n (days); * Not applicable
Changes from baseline in self-reported adherence - asthma control test (ACT) score	Baseline, month 3, month 6	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)
Percentage of patients in treatment	month 3, month 6	Percentage of patients in treatment will be provided
Percentage of patients by level of treatment satisfaction	month 3, month 6	Treatment satisfaction: Very satisfied; * Satisfied; * Not Satisfied/unsatisfied; * Unsatisfied; * Very Unsatisfied
Percentage of patients who downloaded the app in the group of IND/GLY/MF with sensor.	month 3, month 6	Patient downloaded the app: * Yes; * No
percentage of patients with a valid app report in the group of IND/GLY/MF with sensor.	month 3, month 6	Number of patients that downloaded the app
Change from baseline in number of hospitalizations	Baseline, month 3, month 6	Number of hospitalizations and nights: * n of hospitalizations; * n of nights; * Don't know/Don't answer
Change from baseline in number of emergency room visits	Baseline, month 3, month 6	Number of emergency room visits: * n (visits); * Don't know/don't answer
Percentage of patients with desire to continue using sensor/app in the group of IND/GLY/MF with sensor.	month 3, month 6	Desire to continue using the app: * Yes; * No; * Don't know/Don't answer
Percentage of patients with fair acquisition value for sensor/app in the group of IND/GLY/MF with sensor	month 3, month 6	Fair acquisition value of sensor/app: * 0 €; * 1 to 5 €; * 6 to 10€; * 11 to 15 €; * 16 to 20 €; * More than 20 €
Rescue medication from the app	Month 3, Month 6	Rescue medication over last month (n days): * N days; * N days over the night period
Change from baseline in number of scheduled and non-scheduled medical visits	Baseline, month 3, month 6	Number of appointments: * n of scheduled appointments; * n of unscheduled appointments; * Don't know/ Don't answer
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	month 3, month 6	Usefulness of the app report in learning about their asthma: * Yes; * No; * Don't know/Don't answer