SENSE: An Observational Prospective Study to Characterize Patients Initiating Enerzair® Breezhaler®, With or Without Sensor, as a Maintenance Treatment for Asthma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Baseline sociodemographic - living status [Baseline]
Assess if the patient lives alone: Yes No Don't know/ Don't answer
- 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 - 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
- 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
- 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 - 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 - asthma-related hospitalizations [Baseline]
Number of hospitalizations: n of hospitalizations Don't know/Don't answer
- 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 - 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
- clinical characteristics - last asthma treatment [Baseline]
International Nonproprietary Name (INN) of Last asthma medication
Secondary Outcome Measures
- 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
- 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)
- 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
- Rescue medication from the app [Month 3, Month 6]
Rescue medication over last month (n days): N days N days over the night period
- Percentage of patients in treatment [month 3, month 6]
Percentage of patients in treatment will be provided
- 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 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
- 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
- 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
- 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
- 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
- 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
- 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 €
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CQVM149BPT01