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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MF/IND/GLY Breezhaler® plus Propeller Health | patients receiving MF/IND/GLY Breezhaler® plus electronic inhalation tracking sensor (Propeller Health) according to label |
| |
| Other FDC therapy | patients receiving ICS+LABA+LAMA FDC therapy according to label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MF/IND/GLY plus sensor system | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Description of of patient characteristics at baseline |
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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
Exclusion Criteria:
To participate in the study, none of the following exclusion criteria must apply:
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Patients will be enrolled from approximately 25 pulmonology centers across Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ulm | Baden-Wurttemberg | 89073 | Germany | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CQVM149BDE01 that is getting linked from the Novartis Clinical Trials Website | View source |
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|
| FDC therapy | Drug | 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. |
|
Description of patient characteristics at baseline in the treatment groups receiving MF/IND/GLY plus sensor or triple FDC will be provided |
| Baseline |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Adverse events | Adverse events will be provided | 26 weeks |
| Braunschweig |
| Lower Saxonia |
| 38100 |
| Germany |
| Novartis Investigative Site | Hanover | Lower Saxonia | 30449 | Germany |
| Novartis Investigative Site | Ibbenbueren | Rhineland-Palatinate | 49477 | Germany |
| Novartis Investigative Site | Leipzig | Saxony | 04107 | Germany |
| Novartis Investigative Site | Ansbach | 91522 | Germany |
| Novartis Investigative Site | Aschaffenburg | 63739 | Germany |
| Novartis Investigative Site | Augsburg | 86150 | Germany |
| Novartis Investigative Site | Bad Sachsa | 37441 | Germany |
| Novartis Investigative Site | Berlin | 12099 | Germany |
| Novartis Investigative Site | Berlin | 12672 | Germany |
| Novartis Investigative Site | Berlin | 13125 | Germany |
| Novartis Investigative Site | Berlin | 13187 | Germany |
| Novartis Investigative Site | Burgwedel | 30938 | Germany |
| Novartis Investigative Site | Einbeck | 37574 | Germany |
| Novartis Investigative Site | Fürstenwalde | 15517 | Germany |
| Novartis Investigative Site | Göttingen | Germany |
| Novartis Investigative Site | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Hanover | 30163 | Germany |
| Novartis Investigative Site | Leipzig | 04157 | Germany |
| Novartis Investigative Site | Leipzig | D-04347 | Germany |
| Novartis Investigative Site | Marburg | 35037 | Germany |
| Novartis Investigative Site | Markkleeberg | 04416 | Germany |
| Novartis Investigative Site | Papenburg | 26871 | Germany |
| Novartis Investigative Site | Radebeul | 01445 | Germany |
| Novartis Investigative Site | Wiesbaden | 65183 | Germany |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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