Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Under Real-life Conditions

Asthma Clinical Trial

— imPROve  

Official title:

imPROve-asthma - A Prospective, 24-month, Observational Study to Investigate the Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Biologic Therapy Under Real-life Conditions in Germany

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184284
• Other study ID #: D3250R00053
• Status: Completed
• Start date: November 15, 2019
• Est. completion date: December 19, 2023

Study information

• Verified date: January 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients aged 18 years or older with confirmed diagnosis of severe asthma according to the ATS/ERS and local German guidelines

• Decision was made by the investigator (regardless of this NIS) to start treating the patient with benralizumab according to severe eosinophilic asthma indication (NB: can include patients that are switched from another EU approved biologic treatment if required for a medical reason).

• Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol

• After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

• Concomitant treatment with any other biologic for any indication

• Patients already treated with benralizumab

• Clinically important pulmonary disease other than asthma including: chronic obstructive pulmonary disease (as main diagnosis), bronchiectasis, idiopathic pulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsin-deficiency, and malignancy of any kind (NB: the following conditions are permitted: nasal polyposis, allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis).

• An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study or impact the interpretations of results.

• Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment). Acceptable wash-out periods for other asthma biologics: =30 days from last dose of previous biologic

• Pregnancy or lactation period

• Participation in an observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomized clinical trial in the last 3 months

Related Conditions & MeSH terms

• Asthma
• Pulmonary Eosinophilia

Locations

Country	Name	City	State
Germany	Research Site	Aschaffenburg
Germany	Research Site	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	Duesseldorf
Germany	Research Site	Dusseldorf
Germany	Research Site	Flensburg
Germany	Research Site	Frankfurt
Germany	Research Site	Fuerstenwalde
Germany	Research Site	Furstenwalde
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	Hannover
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	Munchen
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	The change in asthma control after 6, 12, 18 and 24 months of treatment in biologic experienced patients, using ACT	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Secondary	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).	6 months after first treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	The reasons for biologic treatment change	Investigator-chosen reasons for; Initiation of benralizumab / switching to benralizumab (treatment change from one biologic to another, regardless of the time since the last dose of the previous biologic) at enrolment; discontinuation of benralizumab during the treatment period.	Date of enrollment until end of follow-up (approx. 24 months after enrollment)