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The main aim of this study is to investigate the change in asthma control after 6 months of therapy in patients treated with benralizumab biologic therapy for severe eosinophilic asthma under real-life conditions in a pulmonary care setting in Germany. The study also aims to investigate Quality-of-Life (QoL), the early treatment response, treatment effectiveness and the change in asthma control over time, following benralizumab therapy. This study will also describe the physician-chosen reasons for starting beralizumab therapy or switching to benralizumab therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Study Cohort - Anti-IL5/IL5R naïve patients | Severe eosinophilic asthma patients who have never received anti-Interleukin-5 / anti-Interleukin-5-receptor (anti-IL-5/anti-IL-5R) biologic treatment for severe eosinophilic asthma, for whom the investigator had decided to initiate benralizumab biologic treatment. | ||
| Secondary Study Cohort - Biologic experienced patients | Patients that previously received a biologic treatment for severe asthma (at least one dose). |
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| Measure | Description | Time Frame |
|---|---|---|
| The change in asthma control after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment | Change from baseline in (Asthma Control Test - questionnaire) ACT score after 6 months treatment in anti-IL5/IL5R naïve patients. ACT is a simple, validated, 5-item tool giving a total score from 5 (worst control) to 25 (best control). Scores of 20 to 25 denote well-controlled asthma, scores ≤19 identifies patients with poorly controlled asthma. The minimum clinically important difference (MCID) is reported to be 3 points. | Baseline and 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| The investigator reported treatment effectiveness after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment | Investigator-reported treatment effectiveness using GETE (Global Evaluation of Treatment Effectiveness) after 6 months of treatment. GETE grades overall treatment effectiveness using the following criteria: excellent (complete control of asthma); good (marked improvement of asthma); moderate (discernible, but limited improvement in asthma); poor (no appreciable change in asthma); or worsening (of asthma). |
| Measure | Description | Time Frame |
|---|---|---|
| The change of physical activity over time in anti-IL5/IL5R naïve patients | Change from baseline in steps per day over 24 months of treatment in anti-IL5/IL5R naïve patients. | Baseline until end of follow-up (approx. 24 months after enrollment) |
| The change in asthma control after 6, 12, 18 and 24 months of treatment in biologic experienced patients, using ACT |
Inclusion Criteria:
Exclusion Criteria:
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approximately 350 to 500 patients in 70 pulmonology sites (hospitals and outpatient practices) in Germany Primary study cohort: approximately 250 patients Secondary study cohort: approximately 100 to 250 patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aschaffenburg | Germany | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40920618 | Derived | Lommatzsch M, Watz H, Grund T, Plate T, Saathoff M, Korn S. Benralizumab-Induced Asthma Remission: Impact of Different Tools and Thresholds to Define Good Asthma Control. Respiration. 2026;105(1):12-21. doi: 10.1159/000548349. Epub 2025 Sep 8. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| 6 months after first treatment |
| The change in health-related quality of life (HRQL) in anti-IL5/IL5R naïve patients initiated with benralizumab treatment | Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score and domain scores (symptoms, activity and impact score) after 6 months treatment in anti-IL5/IL5R naïve patients. SGRQ is a validated, 50-item questionnaire, giving scores ranging from 0 (best health status) to 100 (worst health status). The SGRQ yields a total score and 3 domain scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. A difference of four units in the SGRQ total score is considered the MCID. | Baseline and 6 months after first treatment |
| The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, ACQ-6 | Change from baseline in ACQ-6 (Asthma-Control-Questionnaire-6) score after 7 days of treatment in anti-IL5/IL5R naïve patients. ACQ-6 is a validated questionnaire based on 5 symptoms questions (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing), and daily rescue bronchodilator use. Each item is scored on a 7-point scale (0=no impairment; 6=maximum impairment), and the ACQ score is the mean of these items. The MCID is greater than or equal to 0.5. | Baseline and day 7 after first treatment |
| The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, VAS-1 | Change from baseline in patient satisfaction, measured on Visual Analogue Scale (VAS), after 7 days of treatment in anti-IL5/IL5R naïve patients. VAS Scores ranged from "extremly satisfied" (0 mm) to "not at all satisfied" (100 mm). | Baseline and day 7 after first treatment |
| The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, VAS-2 | Change from baseline in patient symptoms, measured on Visual Analogue Scale (VAS), after 7 days of treatment in anti-IL5/IL5R naïve patients. VAS Scores ranged from "not at all bothersome" (0 mm) to "extremly bothersome" (100 mm). | Baseline and day 7 after first treatment |
| The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 14, ACQ-6 | Change from baseline in ACQ-6 (Asthma-Control-Questionnaire-6) score after 14 days of treatment in anti-IL5/IL5R naïve patients. ACQ-6 is a validated questionnaire based on 5 symptoms questions (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing), and daily rescue bronchodilator use. Each item is scored on a 7-point scale (0=no impairment; 6=maximum impairment), and the ACQ score is the mean of these items. The MCID is greater than or equal to 0.5. | Baseline and day 14 after first treatment |
| The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 14, VAS-1 | Change from baseline in patient satisfaction, measured on Visual Analogue Scale (VAS), after 14 days of treatment in anti-IL5/IL5R naïve patients. VAS Scores ranged from "extremly satisfied" (0 mm) to "not at all satisfied" (100 mm). | Baseline and day 14 after first treatment |
| The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 14, VAS-2 | Change from baseline in patient symptoms, measured on Visual Analogue Scale (VAS), after 14 days of treatment in anti-IL5/IL5R naïve patients. VAS Scores ranged from "not at all bothersome" (0 mm) to "extremly bothersome" (100 mm). | Baseline and day 14 after first treatment |
| The change of asthma control over time and the maintained response after initiation of benralizumab treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment using ACT | Change from baseline in asthma control at each visit during the study period, using ACT in anti-IL5/IL5R naïve patients. ACT is a simple, validated, 5- item tool giving a total score from 5 (worst control) to 25 (best control). Scores of 20 to 25 denote well-controlled asthma, scores ≤19 identifies patients with poorly controlled asthma. The minimum clinically important difference (MCID) is reported to be 3 points. | Date of enrollment until end of follow-up (approx. 24 months after enrollment) |
| The change of asthma control over time and the maintained response after initiation of benralizumab treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment using ACQ-6 | Change from baseline in asthma control at each visit during the study period, using ACQ-6 in anti-IL5/IL5R naïve patients. ACQ-6 is a validated questionnaire based on 5 symptoms questions (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing), and daily rescue bronchodilator use. Each item is scored on a 7-point scale (0=no impairment; 6=maximum impairment), and the ACQ score is the mean of these items. The MCID is greater than or equal to 0.5. | Date of enrollment until end of follow-up (approx. 24 months after enrollment) |
| The reasons for biologic treatment change | Investigator-chosen reasons for
| Date of enrollment until end of follow-up (approx. 24 months after enrollment) |
Change from baseline in (Asthma Control Test - questionnaire) ACT score at the end of 6, 12, 18 and 24 months of benralizumab treatment in biologic experienced patients. ACT is a simple, validated, 5-item tool giving a total score from 5 (worst control) to 25 (best control). Scores of 20 to 25 denote well-controlled asthma, scores ≤19 identifies patients with poorly controlled asthma. The minimum clinically important difference (MCID) is reported to be 3 points. |
| Baseline, 6, 12, 18 and 24 months after first treatment |
| The change in asthma control and the maintained response after initiation of benralizumab treatment in biologic experienced patients using ACQ-6 | Change from baseline in ACQ-6 (Asthma-Control-Questionnaire-6) score at the end of 6, 12, 18 and 24 months of benralizumab treatment in biologic experienced patients. ACQ-6 is a validated questionnaire based on 5 symptoms questions (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing), and daily rescue bronchodilator use. Each item is scored on a 7-point scale (0=no impairment; 6=maximum impairment), and the ACQ score is the mean of these items. The MCID is greater than or equal to 0.5. | Baseline, 6, 12, 18 and 24 months after first treatment |
| The change in HRQL after 6, 12, 18 and 24 months of treatment in biologic experienced patients | Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score and domain scores (symptoms, activity and impact score) after 6, 12, 18 and 24 months treatment in biologic experienced patients. SGRQ is a validated, 50-item questionnaire, giving scores ranging from 0 (best health status) to 100 (worst health status). The SGRQ yields a total score and 3 domain scores (symptoms, activity, and impacts). The total score indicates the impact of disease on overall health status. A difference of four units in the SGRQ total score is considered the MCID. | Baseline, 6, 12, 18 and 24 months after first treatment |
| The early treatment response in biologic experienced patients initiated with benralizumab treatment, ACQ-6 | Change from baseline in ACQ-6 (Asthma-Control-Questionnaire-6) score after 7 and 14 days of treatment in biologic experienced patients. ACQ-6 is a validated questionnaire based on 5 symptoms questions (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing), and daily rescue bronchodilator use. Each item is scored on a 7-point scale (0=no impairment; 6=maximum impairment), and the ACQ score is the mean of these items. The MCID is greater than or equal to 0.5. | Baseline, day 7 and day 14 after first treatment |
| The early treatment response in biologic experienced patients initiated with benralizumab treatment, patient satisfaction, VAS-1 | Change from baseline in patient satisfaction, measured on Visual Analogue Scale (VAS), after 7 and 14 days of treatment in biologic experienced patients. VAS Scores ranged from "extremly satisfied" (0 mm) to "not at all satisfied" (100 mm). | Baseline, day 7 and day 14 after first treatment |
| The early treatment response in biologic experienced patients initiated with benralizumab treatment, patient symptoms, VAS-2 | Change from baseline in patient symptoms, measured on Visual Analogue Scale (VAS), after 7 and 14 days of treatment in biologic experienced patients. VAS Scores ranged from "not at all bothersome" (0 mm) to "extremly bothersome" (100 mm). | Baseline, day 7 and day 14 after first treatment |
| The investigator reported treatment effectiveness after 6 months of treatment in biologic experienced patients initiated with benralizumab treatment | Investigator-reported treatment effectiveness using GETE (Global Evaluation of Treatment Effectiveness) after 6 months of treatment. GETE grades overall treatment effectiveness using the following criteria: excellent (complete control of asthma); good (marked improvement of asthma); moderate (discernible, but limited improvement in asthma); poor (no appreciable change in asthma); or worsening (of asthma). | 6 months after first treatment |
| Augsburg |
| Germany |
| Research Site | Bamberg | Germany |
| Research Site | Beelitz | Germany |
| Research Site | Berlin | Germany |
| Research Site | Biberach | Germany |
| Research Site | Bonn | Germany |
| Research Site | Bremen | Germany |
| Research Site | Cottbus | Germany |
| Research Site | Darmstadt | Germany |
| Research Site | Dresden | Germany |
| Research Site | Düsseldorf | Germany |
| Research Site | Flensburg | Germany |
| Research Site | Frankfurt | Germany |
| Research Site | Fürstenwalde | Germany |
| Research Site | Gelsenkirchen | Germany |
| Research Site | Gerlingen | Germany |
| Research Site | Gotingen | Germany |
| Research Site | Halberstadt | Germany |
| Research Site | Halle | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Hanover | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Hemer | Germany |
| Research Site | Hettstedt | Germany |
| Research Site | Ibbenbueren | Germany |
| Research Site | Immenhausen | Germany |
| Research Site | Konstanz | Germany |
| Research Site | Leipzig | Germany |
| Research Site | Magdeburg | Germany |
| Research Site | Marburg | Germany |
| Research Site | Markkleeberg | Germany |
| Research Site | München | Germany |
| Research Site | Neu-Isenburg | Germany |
| Research Site | Peine | Germany |
| Research Site | Radebeul | Germany |
| Research Site | Regensburg | Germany |
| Research Site | Reinfeld | Germany |
| Research Site | Rheine | Germany |
| Research Site | Rostock | Germany |
| Research Site | Roth | Germany |
| Research Site | Saalfeld | Germany |
| Research Site | Schleswig | Germany |
| Research Site | Teuchern | Germany |
| Research Site | Treuenbrietzen | Germany |
| Research Site | Waren | Germany |
| Research Site | Warendorf | Germany |
| Research Site | Wedel | Germany |
| Research Site | Wiesbaden | Germany |
| Research Site | Witten | 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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