Clinical trial NCT04656223: Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
Official title: Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: mobile Health
mHealth
Propeller Health
MF/IND/GLY Breezhaler®
FDC
Fixed dose combination
Mometasone Fuorat
Indacaterol
Glycopyrronium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-12-07
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled from approximately 25 pulmonology centers across Germany.

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.

Detailed 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.

Eligibility criteria: 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 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:

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 in the last 3 months prior to study entry
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

Primary outcomes:
measure: Change in asthma control test (ACT) score
timeFrame: Baseline, week 26
Secondary outcomes:
measure: Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician
timeFrame: Baseline
measure: Description of of patient characteristics at baseline
timeFrame: Baseline
measure: Percentage of patients showing an improvement in self-reported test adherence to inhalers (TAI) questionnaire
timeFrame: 26 weeks
measure: Course of adherence in the subgroup receiving MF/IND/GLY plus sensor
timeFrame: 26 weeks
measure: Percentage of days with adherence to treatment in the subgroup receiving MF/IND/GLY plus sensor
timeFrame: 26 weeks
measure: Percentage of patients achieving the minimal clinically important difference (MCID) change
timeFrame: Baseline, week 26
measure: Percentage of patients with an ACT score <19
timeFrame: 26 weeks
measure: Change in Post-dose trough Forced Expiratory Volume in one second (FEV1)
timeFrame: Baseline, week 26
measure: Change in Forced vital capacity (FVC)
timeFrame: Baseline, week 26
measure: Adverse events
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Novartis Investigative Site
state: BW
city: Braunschweig
country: Germany
facility: Novartis Investigative Site
state: Lower Saxonia
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Lower Saxonia
city: Ibbenbueren
country: Germany
facility: Novartis Investigative Site
state: Rheinland Pfalz
city: Leipzig
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Ansbach
country: Germany
facility: Novartis Investigative Site
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bad Sachsa
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Burgwedel
country: Germany
facility: Novartis Investigative Site
city: Einbeck
country: Germany
facility: Novartis Investigative Site
city: Furstenwalde
country: Germany
facility: Novartis Investigative Site
city: Goettingen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Markkleeberg
country: Germany
facility: Novartis Investigative Site
city: Papenburg
country: Germany
facility: Novartis Investigative Site
city: Radebeul
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: