Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
NCT ID: NCT04656223
Last Updated: 2024-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
434 participants
OBSERVATIONAL
2020-12-17
2023-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MF/IND/GLY Breezhaler® plus Propeller Health
patients receiving MF/IND/GLY Breezhaler® plus electronic inhalation tracking sensor (Propeller Health) according to label
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.
Other FDC therapy
patients receiving ICS+LABA+LAMA FDC therapy according to label
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.
Interventions
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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.
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
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Inclusion Criteria
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
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
18 Years
99 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Ulm, Baden-Wurttemberg, Germany
Novartis Investigative Site
Braunschweig, Lower Saxonia, Germany
Novartis Investigative Site
Hanover, Lower Saxonia, Germany
Novartis Investigative Site
Ibbenbueren, Rhineland-Palatinate, Germany
Novartis Investigative Site
Leipzig, Saxony, Germany
Novartis Investigative Site
Ansbach, , Germany
Novartis Investigative Site
Aschaffenburg, , Germany
Novartis Investigative Site
Augsburg, , Germany
Novartis Investigative Site
Bad Sachsa, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Burgwedel, , Germany
Novartis Investigative Site
Einbeck, , Germany
Novartis Investigative Site
Fürstenwalde, , Germany
Novartis Investigative Site
Göttingen, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Marburg, , Germany
Novartis Investigative Site
Markkleeberg, , Germany
Novartis Investigative Site
Papenburg, , Germany
Novartis Investigative Site
Radebeul, , Germany
Novartis Investigative Site
Wiesbaden, , Germany
Countries
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Related Links
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Results for CQVM149BDE01 that is getting linked from the Novartis Clinical Trials Website
Other Identifiers
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CQVM149BDE01
Identifier Type: -
Identifier Source: org_study_id
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