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Novartis Farma - Produtos Farmaceuticos S.A. no longer commercializes the product.
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IND/GLY/MF with sensor | Patients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate with sensor |
| |
| IND/GLY/MF without sensor | Patients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate without sensor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IND/GLY/MF | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline sociodemographic - living status | Assess if the patient lives alone:
| Baseline |
| Baseline sociodemographic - household income | Patient's household net income level:
| Baseline |
| Baseline sociodemographic - educational level | Patient's highest completed educational level:
| Baseline |
| Baseline sociodemographic - employment status | Patient Employment status:
| Baseline |
| clinical characteristics - body mass index | body mass index will be provided | Baseline |
| clinical characteristics - smoking status | Patient smoking status:
| Baseline |
| clinical characteristics - comorbidities | Patient comorbidities:
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| Baseline |
| clinical characteristics - duration of disease | duration of disease will be provided | Baseline |
| clinical characteristics - age at asthma diagnosis | Age when asthma was diagnosed:
| Baseline |
| clinical characteristics - asthma-related hospitalizations | Number of hospitalizations:
| Baseline |
| clinical characteristics - emergency admissions and non-scheduled visits in the previous 12 months | Number of appointments:
| 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 |
| 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:
| Month 3, month 6 |
| Rescue medication from the app | Rescue medication over last month (n days):
| 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:
| month 3, month 6 |
| Change from baseline in number of hospitalizations | Number of hospitalizations and nights:
| Baseline, month 3, month 6 |
| Change from baseline in number of emergency room visits | Number of emergency room visits:
| Baseline, month 3, month 6 |
| Change from baseline in number of scheduled and non-scheduled medical visits | Number of appointments:
| 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:
| Baseline, month 3, month 5 |
| Percentage of patients by level of treatment satisfaction | Treatment satisfaction: Very satisfied
| month 3, month 6 |
| Percentage of patients who downloaded the app in the group of IND/GLY/MF with sensor. | Patient downloaded the app:
| 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:
| 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:
| 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:
| 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:
| month 3, month 6 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |