Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions (ADITION)

Novartis

Status: Completed

Conditions: Asthma

Treatments: Combination Product: MF/IND/GLY plus sensor system; Drug: FDC therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT04656223

CQVM149BDE01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 434 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

434 participants in 2 patient groups

MF/IND/GLY Breezhaler® plus Propeller Health

Description:

patients receiving MF/IND/GLY Breezhaler® plus electronic inhalation tracking sensor (Propeller Health) according to label

Treatment:

Combination Product: MF/IND/GLY plus sensor system

Other FDC therapy

Description:

patients receiving ICS+LABA+LAMA FDC therapy according to label

Treatment:

Drug: FDC therapy