Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions

Asthma Clinical Trial

— ADITION  

Official title:

Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04656223
• Other study ID #: CQVM149BDE01
• Status: Completed
• Start date: December 17, 2020
• Est. completion date: January 20, 2023

Study information

• Verified date: March 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.

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.

Locations

Country	Name	City	State
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	Braunschweig	Lower Saxonia
Germany	Novartis Investigative Site	Burgwedel
Germany	Novartis Investigative Site	Einbeck
Germany	Novartis Investigative Site	Furstenwalde
Germany	Novartis Investigative Site	Goettingen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover	Lower Saxonia
Germany	Novartis Investigative Site	Ibbenbueren	Rheinland Pfalz
Germany	Novartis Investigative Site	Leipzig	Sachsen
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	Ulm	BW
Germany	Novartis Investigative Site	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician	Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician will be provided	Baseline
Secondary	Description of of patient characteristics at baseline	Description of patient characteristics at baseline in the treatment groups receiving MF/IND/GLY plus sensor or triple FDC will be provided	Baseline
Secondary	Percentage of patients showing an improvement in self-reported test adherence to inhalers (TAI) questionnaire	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	26 weeks
Secondary	Course of adherence in the subgroup receiving MF/IND/GLY plus sensor	Adherence course according to inhalation tracking data in the subgroup treated with MF/IND/GLY plus sensor will be provided	26 weeks
Secondary	Percentage of days with adherence to treatment in the subgroup receiving MF/IND/GLY plus sensor	Percentage of days with adherence to treatment in the subgroup receiving MF/IND/GLY plus sensor will be provided	26 weeks
Secondary	Percentage of patients achieving the minimal clinically important difference (MCID) change	Percentage of patients achieving the minimal clinically important difference (MCID) change from baseline ACT = 3 points will be provided	Baseline, week 26
Secondary	Percentage of patients with an ACT score <19	Percentage of patients with an ACT score of <19 at baseline and following 26 weeks will be provided	26 weeks
Secondary	Change in Post-dose trough Forced Expiratory Volume in one second (FEV1)	FEV 1 it is the amount that is exhaled in the first second of purposefully trying to breathe out as much air as possible.	Baseline, week 26
Secondary	Change in Forced vital capacity (FVC)	FVC is the volume of air that can forcibly be blown out after full inspiration, measured in liters.	Baseline, week 26
Secondary	Adverse events	Adverse events will be provided	26 weeks

External Links

•   Results for CQVM149BDE01 that is getting linked from the Novartis Clinical Trials Website