AsthmaimPROveNCT04184284
Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Under Real-life Conditions
An observational study of Asthma, run by AstraZeneca at 50 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 246 participants
- Where
- 50 sitesGermany
- Study dates
- 15 Nov 2019to 19 Dec 2023
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
Germany50 sites
Research Site
Aschaffenburg
Research Site
Augsburg
Research Site
Bamberg
Research Site
Beelitz
Research Site
Berlin
Research Site
Biberach
Research Site
Bonn
Research Site
Bremen
Research Site
Cottbus
Research Site
Darmstadt
Research Site
Dresden
Research Site
Düsseldorf
Research Site
Flensburg
Research Site
Frankfurt
Research Site
Fürstenwalde
Research Site
Gelsenkirchen
Research Site
Gerlingen
Research Site
Gotingen
Research Site
Halberstadt
Research Site
Halle
Research Site
Hamburg
Research Site
Hanover
Research Site
Heidelberg
Research Site
Hemer
Research Site
Hettstedt
Research Site
Ibbenbueren
Research Site
Immenhausen
Research Site
Konstanz
Research Site
Leipzig
Research Site
Magdeburg
Research Site
Marburg
Research Site
Markkleeberg
Research Site
München
Research Site
Neu-Isenburg
Research Site
Peine
Research Site
Radebeul
Research Site
Regensburg
Research Site
Reinfeld
Research Site
Rheine
Research Site
Rostock
Research Site
Roth
Research Site
Saalfeld
Research Site
Schleswig
Research Site
Teuchern
Research Site
Treuenbrietzen
Research Site
Waren
Research Site
Warendorf
Research Site
Wedel
Research Site
Wiesbaden
Research Site
Witten
About this study
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
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.
- Conditions
- Asthma
- Keywords
- benralizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months after baseline
Secondary outcomes (11)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Date of enrollment until end of follow-up (approx. 24 months after enrollment)
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.
Measured: Date of enrollment until end of follow-up (approx. 24 months after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start15 Nov 2019
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184284
- Sponsor's protocol ID
- D3250R00053
- Acronym
- imPROve
- Status last verified
- Dec 2024
- First submitted
- 13 Oct 2019
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40920618
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04184284
- Acronym / sponsor ID
- imPROve / D3250R00053
- Conditions
- Asthma
- Keywords
- benralizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change in asthma control after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment
Time frame: Baseline and 6 months after baseline
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.
11 secondary outcomes
The investigator reported treatment effectiveness after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment
Time frame: 6 months after first treatment
The change in health-related quality of life (HRQL) in anti-IL5/IL5R naïve patients initiated with benralizumab treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Date of enrollment until end of follow-up (approx. 24 months after enrollment)
The reasons for biologic treatment change
Time frame: Date of enrollment until end of follow-up (approx. 24 months after enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 40920618Lommatzsch 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.
- CSR SynopsisLink provided by the sponsor.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 50 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in asthma control after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment (time frame: Baseline and 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04184284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.