ADITION: Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04656223

Collaborator

(none)

425

Enrollment

Locations

24.4

Anticipated Duration (Months)

16.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Combination Product: MF/IND/GLY plus sensor system Drug: FDC therapy

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.

Study Design

Study Type:

Observational

Actual Enrollment :

425 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions

Actual Study Start Date :

Dec 17, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
MF/IND/GLY Breezhaler® plus Propeller Health patients receiving MF/IND/GLY Breezhaler® plus electronic inhalation tracking sensor (Propeller Health) according to label	Combination Product: 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	Drug: 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.

Arm

Intervention/Treatment

MF/IND/GLY Breezhaler® plus Propeller Health

patients receiving MF/IND/GLY Breezhaler® plus electronic inhalation tracking sensor (Propeller Health) according to label

Combination Product: 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

Drug: 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.

Outcome Measures

Primary Outcome Measures

Change in asthma control test (ACT) score [Baseline, week 26]
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.

Secondary Outcome Measures

Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician [Baseline]
Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician will be provided
Description of of patient characteristics at baseline [Baseline]
Description of patient characteristics at baseline in the treatment groups receiving MF/IND/GLY plus sensor or triple FDC will be provided
Percentage of patients showing an improvement in self-reported test adherence to inhalers (TAI) questionnaire [26 weeks]
TAI test is a 12-item questionnaire designed to assess the adherence to inhalers in patients with asthma. Ten questions are answered by the patients, and have to rate each question from 1 to 5. Total score can go between 10 and 50; 50 points correlates to "adherent", 46-49 points correlates to "moderate adherent" and lower than 45 points correlate to "not adherent". Two additional questions are answered by the physician
Course of adherence in the subgroup receiving MF/IND/GLY plus sensor [26 weeks]
Adherence course according to inhalation tracking data in the subgroup treated with MF/IND/GLY plus sensor will be provided
Percentage of days with adherence to treatment 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 will be provided
Percentage of patients achieving the minimal clinically important difference (MCID) change [Baseline, week 26]
Percentage of patients achieving the minimal clinically important difference (MCID) change from baseline ACT ≥ 3 points will be provided
Percentage of patients with an ACT score <19 [26 weeks]
Percentage of patients with an ACT score of <19 at baseline and following 26 weeks will be provided
Change in Post-dose trough Forced Expiratory Volume in one second (FEV1) [Baseline, week 26]
FEV 1 it is the amount that is exhaled in the first second of purposefully trying to breathe out as much air as possible.
Change in Forced vital capacity (FVC) [Baseline, week 26]
FVC is the volume of air that can forcibly be blown out after full inspiration, measured in liters.
Adverse events [26 weeks]
Adverse events will be provided

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Ulm	BW	Germany	89073
2	Novartis Investigative Site	Braunschweig	Lower Saxonia	Germany	38100
3	Novartis Investigative Site	Hannover	Lower Saxonia	Germany	30449
4	Novartis Investigative Site	Ibbenbueren	Rheinland Pfalz	Germany	49477
5	Novartis Investigative Site	Leipzig	Sachsen	Germany	04107
6	Novartis Investigative Site	Ansbach		Germany	91522
7	Novartis Investigative Site	Aschaffenburg		Germany	63739
8	Novartis Investigative Site	Augsburg		Germany	86150
9	Novartis Investigative Site	Bad Sachsa		Germany	37441
10	Novartis Investigative Site	Berlin		Germany	12099
11	Novartis Investigative Site	Berlin		Germany	12672
12	Novartis Investigative Site	Berlin		Germany	13125
13	Novartis Investigative Site	Berlin		Germany	13187
14	Novartis Investigative Site	Burgwedel		Germany	30938
15	Novartis Investigative Site	Einbeck		Germany	37574
16	Novartis Investigative Site	Furstenwalde		Germany	15517
17	Novartis Investigative Site	Goettingen		Germany
18	Novartis Investigative Site	Hamburg		Germany	20354
19	Novartis Investigative Site	Hannover		Germany	30163
20	Novartis Investigative Site	Leipzig		Germany	04157
21	Novartis Investigative Site	Leipzig		Germany	D-04347
22	Novartis Investigative Site	Marburg		Germany	35037
23	Novartis Investigative Site	Markkleeberg		Germany	04416
24	Novartis Investigative Site	Papenburg		Germany	26871
25	Novartis Investigative Site	Radebeul		Germany	01445
26	Novartis Investigative Site	Wiesbaden		Germany	65183