Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions

Last updated: March 22, 2024
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

N/A

Condition

Asthma

Treatment

FDC therapy

MF/IND/GLY plus sensor system

Clinical Study ID

NCT04656223
CQVM149BDE01
  • Ages 18-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 oranother 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 thesensor system or another ICS+LABA+LAMA FDC according to the therapy decision of thetreating 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 storagespace) and which is capable of establishing a Bluetooth connection to the sensorThe patient must agree to activate the app, the Bluetooth connection and themobile data connection regularly (at least once a month).
  • Availability of an e-mail address

Exclusion

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 inthe last 3 months prior to study entry
  2. Simultaneous participation in an interventional study or in another Novartis-sponsorednoninterventional study
  3. Asthma therapy with a biological agent, if not stable at the same dosage for at least 3 months

Study Design

Total Participants: 434
Treatment Group(s): 2
Primary Treatment: FDC therapy
Phase:
Study Start date:
December 17, 2020
Estimated Completion Date:
January 20, 2023

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Ulm, BW 89073
    Germany

    Site Not Available

  • Novartis Investigative Site

    Braunschweig, Lower Saxonia 38100
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hannover, Lower Saxonia 30449
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ibbenbueren, Rheinland Pfalz 49477
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ansbach, 91522
    Germany

    Site Not Available

  • Novartis Investigative Site

    Aschaffenburg, 63739
    Germany

    Site Not Available

  • Novartis Investigative Site

    Augsburg, 86150
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bad Sachsa, 37441
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 12672
    Germany

    Site Not Available

  • Novartis Investigative Site

    Biberach,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Burgwedel, 30938
    Germany

    Site Not Available

  • Novartis Investigative Site

    Einbeck, 37574
    Germany

    Site Not Available

  • Novartis Investigative Site

    Fuerth,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Furstenwalde, 15517
    Germany

    Site Not Available

  • Novartis Investigative Site

    Goettingen,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gummersbach, 51343
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 20354
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hettstedt, 06333
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig, 04157
    Germany

    Site Not Available

  • Novartis Investigative Site

    Marburg, 35037
    Germany

    Site Not Available

  • Novartis Investigative Site

    Markkleeberg, 04416
    Germany

    Site Not Available

  • Novartis Investigative Site

    Papenburg, 26871
    Germany

    Site Not Available

  • Novartis Investigative Site

    Radebeul, 01445
    Germany

    Site Not Available

  • Novartis Investigative Site

    Roth, 91154
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wiesbaden, 65183
    Germany

    Site Not Available

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