Asthma Clinical Trial
— ADITIONOfficial title:
Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
Verified date | March 2024 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Germany,
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 |
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