An observational study in Asthma, sponsored by Novartis Pharmaceuticals. Withdrawn. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by Novartis Pharmaceuticals · Observational
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
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
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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.
Exclusion Criteria:
Patients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate with sensor
Other: IND/GLY/MF
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
Also known as: Enerzair® Breezhaler®
Baseline sociodemographic - living status
Assess if the patient lives alone: * Yes * No * Don't know/ Don't answer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline
clinical characteristics - body mass index
body mass index will be provided
Time frame: Baseline
clinical characteristics - smoking status
Patient smoking status: * Never smoked * Ex-smoker * Smoker * Don't know/Don't answer
Time frame: Baseline
clinical characteristics - comorbidities
Patient comorbidities: * Allergic rhinitis * Rhinosinusitis * Allergic conjunctivitis * Sleep disorders * Anxiety * Depression * Other. Specify
Time frame: Baseline
clinical characteristics - duration of disease
duration of disease will be provided
Time frame: Baseline
clinical characteristics - age at asthma diagnosis
Age when asthma was diagnosed: * Years * Unknown/cannot remember
Time frame: Baseline
clinical characteristics - asthma-related hospitalizations
Number of hospitalizations: * n of hospitalizations * Don't know/Don't answer
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Baseline
clinical characteristics - last asthma treatment
International Nonproprietary Name (INN) of Last asthma medication
Time frame: Baseline
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
Time frame: 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)
Time frame: Baseline, month 3, month 6
Adherence from the app (percentage)
Adherence over last month to be measured using a scale from 0 to 100
Time frame: Month 3, month 6
Asthma control from the app (category)
Asthma control over last month: * Well controlled * Not properly controlled * Poorly controlled * Unknown
Time frame: Month 3, month 6
Rescue medication from the app
Rescue medication over last month (n days): * N days * N days over the night period
Time frame: Month 3, Month 6
Percentage of patients in treatment
Percentage of patients in treatment will be provided
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, month 3, month 5
Percentage of patients by level of treatment satisfaction
Treatment satisfaction: Very satisfied * Satisfied * Not Satisfied/unsatisfied * Unsatisfied * Very Unsatisfied
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 €
Time frame: month 3, month 6
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals