Clinical trial NCT05120986: An Observational Prospective Study to Characterize Patients Initiating Enerzair® Breezhaler®, With or Without Sensor, as a Maintenance Treatment for Asthma
Official title: Sensor: ENhancing aSthma carE - An Observational Prospective Study to Characterize Patients Initiating Indacaterol + Glycopyrronium Bromide + Mometasone Furoate (Enerzair® Breezhaler®), With or Without Sensor, as a Maintenance Treatment for Asthma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Asthma
Keywords: Asthma
SENSE study
Enerzair
Breezhaler
maintenance treatment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-11-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility 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.

Primary outcomes:
measure: Baseline sociodemographic - living status
timeFrame: Baseline
measure: Baseline sociodemographic - household income
timeFrame: Baseline
measure: Baseline sociodemographic - educational level
timeFrame: Baseline
measure: Baseline sociodemographic - employment status
timeFrame: Baseline
measure: clinical characteristics - body mass index
timeFrame: Baseline
measure: clinical characteristics - smoking status
timeFrame: Baseline
measure: clinical characteristics - comorbidities
timeFrame: Baseline
measure: clinical characteristics - duration of disease
timeFrame: Baseline
measure: clinical characteristics - age at asthma diagnosis
timeFrame: Baseline
measure: clinical characteristics - asthma-related hospitalizations
timeFrame: Baseline
measure: clinical characteristics - emergency admissions and non-scheduled visits in the previous 12 months
timeFrame: Baseline
measure: clinical characteristics - ACT score
timeFrame: Baseline
measure: clinical characteristics - TAI score
timeFrame: Baseline
measure: clinical characteristics - last asthma treatment
timeFrame: Baseline
Secondary outcomes:
measure: Changes from baseline in self-reported adherence - TAI questionnaire score
timeFrame: Baseline, month 3, month 6
measure: Changes from baseline in self-reported adherence - asthma control test (ACT) score
timeFrame: Baseline, month 3, month 6
measure: Adherence from the app (percentage)
timeFrame: Month 3, month 6
measure: Asthma control from the app (category)
timeFrame: Month 3, month 6
measure: Rescue medication from the app
timeFrame: Month 3, Month 6
measure: Percentage of patients in treatment
timeFrame: month 3, month 6
measure: Reasons for discontinuation and treatment switch
timeFrame: month 3, month 6
measure: Change from baseline in number of hospitalizations
timeFrame: Baseline, month 3, month 6
measure: Change from baseline in number of emergency room visits
timeFrame: Baseline, month 3, month 6
measure: Change from baseline in number of scheduled and non-scheduled medical visits
timeFrame: Baseline, month 3, month 6
measure: Change from baseline in number of work hours/days missed
timeFrame: Baseline, month 3, month 5
measure: Percentage of patients by level of treatment satisfaction
timeFrame: month 3, month 6
measure: Percentage of patients who downloaded the app in the group of IND/GLY/MF with sensor.
timeFrame: month 3, month 6
measure: percentage of patients with a valid app report in the group of IND/GLY/MF with sensor.
timeFrame: month 3, month 6
measure: 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
timeFrame: month 3, month 6
measure: 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
timeFrame: month 3, month 6
measure: Percentage of patients with desire to continue using sensor/app in the group of IND/GLY/MF with sensor.
timeFrame: month 3, month 6
measure: Percentage of patients with fair acquisition value for sensor/app in the group of IND/GLY/MF with sensor
timeFrame: month 3, month 6
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmceuticals
role: STUDY_DIRECTOR
References: