Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions

ClinicalTrials.gov Identifier: NCT04656223

Novartis Reference Number: CQVM149BDE01

Last Update: May 09, 2022

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Asthma

Phase

Not Given

Overall status

Recruiting

Start date

Dec 17, 2020

Completion date

Dec 31, 2022

Gender

All

Age(s)

18 Years - 99 Years (Adult, Older Adult)

Interventions

Combination Product

MF/IND/GLY plus sensor system

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.

Drug

FDC therapy

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 Criteria

Inclusion Criteria:

To participate in the study, all of the following inclusion criteria must be met:

Patients (m/f/d) at the age of ≥18
Written declaration of consent
Asthma diagnosis according to German Asthma Guideline NVL, 4th edition
Suitability for a therapy with MF/IND/GLY in combination with the sensor system or another ICS+LABA+LAMA FDC according to SPC
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
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
Availability of at least one ACT value of the last 6 months before consent

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:

Use of a digital inhaler-coupled inhalation tracking system to support adherence in the last 3 months prior to study entry
Simultaneous participation in an interventional study or in another Novartis-sponsored noninterventional study
Asthma therapy with a biological agent, if not stable at the same dosage for at least 3 months