Asthma
Conditions
Keywords
Asthma, SENSE study, Enerzair, Breezhaler, maintenance treatment
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
Interventions
OTHERIND/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
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical characteristics - last asthma treatment | Baseline | International Nonproprietary Name (INN) of Last asthma medication |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 in treatment | month 3, month 6 | Percentage of patients in treatment will be provided |
| 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 € |
| 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 |
| 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 |
| 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 |
Outcome results
None listed