Phase
Condition
Asthma
Treatment
FDC therapy
MF/IND/GLY plus sensor system
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 oranother 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 thesensor system or another ICS+LABA+LAMA FDC according to the therapy decision of thetreating 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 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:
- Use of a digital inhaler-coupled inhalation tracking system to support adherence inthe last 3 months prior to study entry
- Simultaneous participation in an interventional study or in another Novartis-sponsorednoninterventional study
- Asthma therapy with a biological agent, if not stable at the same dosage for at least 3 months
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Ulm, BW 89073
GermanySite Not Available
Novartis Investigative Site
Braunschweig, Lower Saxonia 38100
GermanySite Not Available
Novartis Investigative Site
Hannover, Lower Saxonia 30449
GermanySite Not Available
Novartis Investigative Site
Ibbenbueren, Rheinland Pfalz 49477
GermanySite Not Available
Novartis Investigative Site
Ansbach, 91522
GermanySite Not Available
Novartis Investigative Site
Aschaffenburg, 63739
GermanySite Not Available
Novartis Investigative Site
Augsburg, 86150
GermanySite Not Available
Novartis Investigative Site
Bad Sachsa, 37441
GermanySite Not Available
Novartis Investigative Site
Berlin, 12672
GermanySite Not Available
Novartis Investigative Site
Biberach,
GermanySite Not Available
Novartis Investigative Site
Burgwedel, 30938
GermanySite Not Available
Novartis Investigative Site
Einbeck, 37574
GermanySite Not Available
Novartis Investigative Site
Fuerth,
GermanySite Not Available
Novartis Investigative Site
Furstenwalde, 15517
GermanySite Not Available
Novartis Investigative Site
Goettingen,
GermanySite Not Available
Novartis Investigative Site
Gummersbach, 51343
GermanySite Not Available
Novartis Investigative Site
Hamburg, 20354
GermanySite Not Available
Novartis Investigative Site
Hettstedt, 06333
GermanySite Not Available
Novartis Investigative Site
Leipzig, 04157
GermanySite Not Available
Novartis Investigative Site
Marburg, 35037
GermanySite Not Available
Novartis Investigative Site
Markkleeberg, 04416
GermanySite Not Available
Novartis Investigative Site
Papenburg, 26871
GermanySite Not Available
Novartis Investigative Site
Radebeul, 01445
GermanySite Not Available
Novartis Investigative Site
Roth, 91154
GermanySite Not Available
Novartis Investigative Site
Wiesbaden, 65183
GermanySite Not Available

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