Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
ADITION
1 other identifier
observational
434
1 country
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 7, 2020
CompletedStudy Start
First participant enrolled
December 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2023
CompletedMarch 25, 2024
March 1, 2024
2.1 years
November 30, 2020
March 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, week 26
Secondary Outcomes (10)
Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician
Baseline
Description of of patient characteristics at baseline
Baseline
Percentage of patients showing an improvement in self-reported test adherence to inhalers (TAI) questionnaire
26 weeks
Course of adherence in the subgroup receiving MF/IND/GLY plus sensor
26 weeks
Percentage of days with adherence to treatment in the subgroup receiving MF/IND/GLY plus sensor
26 weeks
- +5 more secondary outcomes
Study Arms (2)
MF/IND/GLY Breezhaler® plus Propeller Health
patients receiving MF/IND/GLY Breezhaler® plus electronic inhalation tracking sensor (Propeller Health) according to label
Other FDC therapy
patients receiving ICS+LABA+LAMA FDC therapy according to label
Interventions
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.
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
Patients will be enrolled from approximately 25 pulmonology centers across Germany.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Novartis Investigative Site
Ulm, Baden-Wurttemberg, 89073, Germany
Novartis Investigative Site
Braunschweig, Lower Saxonia, 38100, Germany
Novartis Investigative Site
Hanover, Lower Saxonia, 30449, Germany
Novartis Investigative Site
Ibbenbueren, Rhineland-Palatinate, 49477, Germany
Novartis Investigative Site
Leipzig, Saxony, 04107, Germany
Novartis Investigative Site
Ansbach, 91522, Germany
Novartis Investigative Site
Aschaffenburg, 63739, Germany
Novartis Investigative Site
Augsburg, 86150, Germany
Novartis Investigative Site
Bad Sachsa, 37441, Germany
Novartis Investigative Site
Berlin, 12099, Germany
Novartis Investigative Site
Berlin, 12672, Germany
Novartis Investigative Site
Berlin, 13125, Germany
Novartis Investigative Site
Berlin, 13187, Germany
Novartis Investigative Site
Burgwedel, 30938, Germany
Novartis Investigative Site
Einbeck, 37574, Germany
Novartis Investigative Site
Fürstenwalde, 15517, Germany
Novartis Investigative Site
Göttingen, Germany
Novartis Investigative Site
Hamburg, 20354, Germany
Novartis Investigative Site
Hanover, 30163, Germany
Novartis Investigative Site
Leipzig, 04157, Germany
Novartis Investigative Site
Leipzig, D-04347, Germany
Novartis Investigative Site
Marburg, 35037, Germany
Novartis Investigative Site
Markkleeberg, 04416, Germany
Novartis Investigative Site
Papenburg, 26871, Germany
Novartis Investigative Site
Radebeul, 01445, Germany
Novartis Investigative Site
Wiesbaden, 65183, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2020
First Posted
December 7, 2020
Study Start
December 17, 2020
Primary Completion
January 20, 2023
Study Completion
January 20, 2023
Last Updated
March 25, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share