- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04656223
Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions (ADITION)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ansbach, Germany, 91522
- Novartis Investigative Site
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Aschaffenburg, Germany, 63739
- Novartis Investigative Site
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Augsburg, Germany, 86150
- Novartis Investigative Site
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Bad Sachsa, Germany, 37441
- Novartis Investigative Site
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Berlin, Germany, 13125
- Novartis Investigative Site
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Berlin, Germany, 12099
- Novartis Investigative Site
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Berlin, Germany, 13187
- Novartis Investigative Site
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Berlin, Germany, 12672
- Novartis Investigative Site
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Burgwedel, Germany, 30938
- Novartis Investigative Site
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Einbeck, Germany, 37574
- Novartis Investigative Site
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Furstenwalde, Germany, 15517
- Novartis Investigative Site
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Goettingen, Germany
- Novartis Investigative Site
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Hamburg, Germany, 20354
- Novartis Investigative Site
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Hannover, Germany, 30163
- Novartis Investigative Site
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Leipzig, Germany, 04157
- Novartis Investigative Site
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Leipzig, Germany, D-04347
- Novartis Investigative Site
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Marburg, Germany, 35037
- Novartis Investigative Site
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Markkleeberg, Germany, 04416
- Novartis Investigative Site
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Papenburg, Germany, 26871
- Novartis Investigative Site
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Radebeul, Germany, 01445
- Novartis Investigative Site
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Wiesbaden, Germany, 65183
- Novartis Investigative Site
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BW
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Ulm, BW, Germany, 89073
- Novartis Investigative Site
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Lower Saxonia
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Braunschweig, Lower Saxonia, Germany, 38100
- Novartis Investigative Site
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Hannover, Lower Saxonia, Germany, 30449
- Novartis Investigative Site
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Rheinland Pfalz
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Ibbenbueren, Rheinland Pfalz, Germany, 49477
- Novartis Investigative Site
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Sachsen
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Leipzig, Sachsen, Germany, 04107
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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
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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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in asthma control test (ACT) score
Time Frame: Baseline, week 26
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician
Time Frame: Baseline
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Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician will be provided
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Baseline
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Description of of patient characteristics at baseline
Time Frame: Baseline
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Description of patient characteristics at baseline in the treatment groups receiving MF/IND/GLY plus sensor or triple FDC will be provided
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Baseline
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Percentage of patients showing an improvement in self-reported test adherence to inhalers (TAI) questionnaire
Time Frame: 26 weeks
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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
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Course of adherence in the subgroup receiving MF/IND/GLY plus sensor
Time Frame: 26 weeks
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Adherence course according to inhalation tracking data in the subgroup treated with MF/IND/GLY plus sensor will be provided
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26 weeks
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Percentage of days with adherence to treatment in the subgroup receiving MF/IND/GLY plus sensor
Time Frame: 26 weeks
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Percentage of days with adherence to treatment in the subgroup receiving MF/IND/GLY plus sensor will be provided
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26 weeks
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Percentage of patients achieving the minimal clinically important difference (MCID) change
Time Frame: Baseline, week 26
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Percentage of patients achieving the minimal clinically important difference (MCID) change from baseline ACT ≥ 3 points will be provided
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Baseline, week 26
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Percentage of patients with an ACT score <19
Time Frame: 26 weeks
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Percentage of patients with an ACT score of <19 at baseline and following 26 weeks will be provided
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26 weeks
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Change in Post-dose trough Forced Expiratory Volume in one second (FEV1)
Time Frame: Baseline, week 26
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FEV 1 it is the amount that is exhaled in the first second of purposefully trying to breathe out as much air as possible.
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Baseline, week 26
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Change in Forced vital capacity (FVC)
Time Frame: Baseline, week 26
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FVC is the volume of air that can forcibly be blown out after full inspiration, measured in liters.
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Baseline, week 26
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Adverse events
Time Frame: 26 weeks
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Adverse events will be provided
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26 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CQVM149BDE01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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