Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions

Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions

ClinicalTrials.gov Identifier: NCT04656223

Novartis Reference Number: CQVM149BDE01

Last Update: May 09, 2022

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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

Study Locations

Germany
Novartis Investigative Site
Recruiting
Ulm, 89073
BW
Germany
Novartis Investigative Site
Recruiting
Braunschweig, 38100
Lower Saxonia
Germany
Novartis Investigative Site
Recruiting
Hannover, 30449
Lower Saxonia
Germany
Novartis Investigative Site
Recruiting
Ibbenbueren, 49477
Rheinland Pfalz
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04107
Sachsen
Germany
Novartis Investigative Site
Recruiting
Ansbach, 91522
-
Germany
Novartis Investigative Site
Recruiting
Aschaffenburg, 63739
-
Germany
Novartis Investigative Site
Recruiting
Augsburg, 86150
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 12099
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 12672
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13125
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13187
-
Germany
Novartis Investigative Site
Recruiting
Burgwedel, 30938
-
Germany
Novartis Investigative Site
Recruiting
Einbeck, 37574
-
Germany
Novartis Investigative Site
Recruiting
Furstenwalde, 15517
-
Germany
Novartis Investigative Site
Recruiting
Goettingen,
-
Germany
Novartis Investigative Site
Recruiting
Hamburg, 20354
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30163
-
Germany
Novartis Investigative Site
Recruiting
Hettstedt, 06333
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04157
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, D-04347
-
Germany
Novartis Investigative Site
Recruiting
Marburg, 35037
-
Germany
Novartis Investigative Site
Recruiting
Markkleeberg, 04416
-
Germany
Novartis Investigative Site
Recruiting
Papenburg, 26871
-
Germany
Novartis Investigative Site
Recruiting
Radebeul, 01445
-
Germany
Novartis Investigative Site
Recruiting
Roth, 91154
-
Germany
Novartis Investigative Site
Recruiting
Wiesbaden, 65183
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]