Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions

Novartis Pharmaceuticals434 enrolled

Overview

This study is designed as a multicenter, observational, non-interventional, open label, 26-week study in order to observe how asthma control changes under treatment with Mometasone Fuorat/Indacaterol/ Glycopyrronium (MF/IND/GLY) Breezhaler® sensor system or under treatment with fixed-dose combination (FDC) triple therapy after 26 weeks of treatment.

Subjects in one group will receive MF/IND/GLY together with the Propeller add-on sensor for the Breezhaler® and access to the smartphone app according to label. Subjects in the other group will receive any triple FDC according to label. The physician's decision to initiate or switch a patient to MF/IND/GLY Breezhaler® system or any other triple FDC must have been taken prior to and independently from the decision to include the patient in the study.

Study Type

OBSERVATIONAL

Enrollment

434

Conditions

Asthma

Interventions

MF/IND/GLY plus sensor systemCOMBINATION_PRODUCT

There is no treatment allocation. Patients administered MF/IND/GLY plus sensor system by prescription that have started before inclusion of the patient into the study will be enrolled. Subjects will receive MF/IND/GLY together with the Propeller add-on sensor for the Breezhaler® according to label.

FDC therapyDRUG

There is no treatment allocation. Patients administered FDC therapy by prescription that have started before inclusion of the patient into the study will be enrolled.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: To participate in the study, all of the following inclusion criteria must be met: 1. Patients (m/f/d) at the age of ≥18 2. Written declaration of consent 3. Asthma diagnosis according to German Asthma Guideline NVL, 4th edition 4. Suitability for a therapy with MF/IND/GLY in combination with the sensor system or another ICS+LABA+LAMA FDC according to SPC 5. At least 6 months of inhaled therapy with ICS+LABA (high dose) or ICS+LABA+LAMA (medium or high dose) before switching or escalating asthma medication at baseline 6. Change or escalation of the asthma medication to MF/IND/GLY in combination with the sensor system or another ICS+LABA+LAMA FDC according to the therapy decision of the treating physician 7. Availability of at least one ACT value of the last 6 months before consent 8. Cohort treated with MF/IND/GLY in combination with the sensor system * Owning an Android or iOS smartphone or tablet on which the app can be installed (via WiFi or mobile data network) and run (requires about 75 megabytes of storage space) and which is capable of establishing a Bluetooth connection to the sensor The patient must agree to activate the app, the Bluetooth connection and the mobile data connection regularly (at least once a month). * Availability of an e-mail address Exclusion Criteria: To participate in the study, none of the following exclusion criteria must apply: 1. Use of a digital inhaler-coupled inhalation tracking system to support adherence in the last 3 months prior to study entry 2. Simultaneous participation in an interventional study or in another Novartis-sponsored noninterventional study 3. Asthma therapy with a biological agent, if not stable at the same dosage for at least 3 months

Locations (26)

Novartis Investigative Site

Ulm, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

Change in asthma control test (ACT) score

ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. It is a self-administered questionnaire comprising five items that are assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of \>=20 denoting 'controlled asthma', a score of 16-19 denoting 'partially controlled asthma', and a score of \<=15 denoting 'uncontrolled asthma'. The total score is calculated as the sum of the scores from all 5 questions. Higher scores indicates improved asthma control.

Time frame: Baseline, week 26

Secondary Outcomes

Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician

Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician will be provided

Time frame: Baseline

Description of of patient characteristics at baseline

Description of patient characteristics at baseline in the treatment groups receiving MF/IND/GLY plus sensor or triple FDC will be provided

Time frame: Baseline

Percentage of patients showing an improvement in self-reported test adherence to inhalers (TAI) questionnaire

TAI test is a 12-item questionnaire designed to assess the adherence to inhalers in patients with asthma. Ten questions are answered by the patients, and have to rate each question from 1 to 5. Total score can go between 10 and 50; 50 points correlates to "adherent", 46-49 points correlates to "moderate adherent" and lower than 45 points correlate to "not adherent". Two additional questions are answered by the physician

Time frame: 26 weeks

Course of adherence in the subgroup receiving MF/IND/GLY plus sensor

Data from ClinicalTrials.gov

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