Last updated: 07/07/2023 11:10:14
Real world study of severe eosinophilic asthma in Germany
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Characterization of the patient population and the treatment outcomes of patients with severe eosinophilic asthma treated with mepolizumab in real-life clinical practice in Germany – data from the Severe Asthma Registry of the German Asthma Net (MepoGAN-study)
Trial description: Mepolizumab is a biological agent targeting the interleukin-5 (IL-5) pathway, approved for the treatment of severe eosinophilic asthma. The purpose of this real world study is to describe the use of mepolizumab in clinical practice in Germany based on the available data from the German Asthma Network (GAN) registry. The study also aims to describe the treatment outcomes with mepolizumab in a real-world population. Participants who have received mepolizumab and entered GAN registry will be identified from 01-Oct-2019 to 30-Apr-2020. NUCALA is a registered trademark for GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with demographics characteristics - GAN questionnaire antibody version
Timeframe: At Baseline
Number of participants with disease characteristics - GAN questionnaire antibody version
Timeframe: Up to 4 months
Number of participants receiving asthma medication - GAN questionnaire antibody version
Timeframe: Up to 4 months
Number of participants with disease control - GAN questionnaire antibody version
Timeframe: Up to 4 months
Number of participants undergoing lung function test- GAN questionnaire antibody version
Timeframe: Up to 4 months
Number of participants with demographics characteristics - GAN questionnaire full version
Timeframe: At Baseline
Number of participants with disease characteristics - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants receiving asthma medication - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants with disease control - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants undergoing lung function test - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants with allergic conditions - GAN questionnaire full version
Timeframe: At Baseline
Number of participants with comorbidities - GAN questionnaire full version
Timeframe: At Baseline
Secondary outcomes:
Number of participants with GINA control status - GAN questionnaire antibody version
Timeframe: Up to 4 months
Number of participants with abnormal lung function test - GAN questionnaire antibody version
Timeframe: Up to 4 months
Number of participants with use of maintenance oral corticosteroids (OCS) or systemic steroids - GAN questionnaire antibody version
Timeframe: Up to 4 months
Number of participants with abnormal eosinophils (EOS) count - GAN questionnaire antibody version
Timeframe: Up to 4 months
Number of participants with treatment response to mepolizumab - GAN questionnaire antibody version
Timeframe: Up to 4 months
Number of participants with adverse events (AEs) - GAN questionnaire antibody version
Timeframe: Up to 4 months
Number of participants with adverse drug reactions (ADRs) - GAN questionnaire antibody version
Timeframe: Up to 4 months
Number of participants with GINA control status - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants with ACQ-5 - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants with ACT - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants with Mini-AQLQ - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants with abnormal lung function test - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants with disease symptoms - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants receiving medication on demand - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants with use of maintenance oral corticosteroids (OCS) or systemic steroids - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants with exacerbations - GAN questionnaire full version
Timeframe: Up to 1 year
Number of participants with treatment response to mepolizumab - GAN questionnaire full version
Timeframe: Up to 1 year
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-01-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Stephanie Korn, Katrin Milger, Dirk Skowasch, Christian Schulz, Cordula Mohrlang, Martin Wernitz, Thomas Paulsson, Michael Hennig, Roland Buhl. Real-World Experience on the Use of Mepolizumab from the Severe Asthma Registry of the German Asthma Net (MepoGAN-Study). Journal of Asthma and Allergy. 2023-5;Volume 16(n/a): 541-552.
DOI: 10.2147/JAA.S403286
PMID: 37197193
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
April 2020 to June 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 Years - NA
Accepts healthy volunteers
No
- Adults greater than equal to (>=)18 years of age.
- Diagnosis of severe asthma.
- Only GAN questionnaire full version cohort: Off-label use of mepolizumab
- Only GAN questionnaire antibody version cohort: No blood eosinophil measurement† recorded in the database (current or last two years)
Inclusion and exclusion criteria
Inclusion criteria:
- Adults greater than equal to (>=)18 years of age.
- Diagnosis of severe asthma.
- Only GAN questionnaire full version cohort: In-label treatment with mepolizumab.
- Only GAN questionnaire antibody version cohort: Blood eosinophil measurement recorded in the database (current or last two years).
Exclusion criteria:
- Only GAN questionnaire full version cohort: Off-label use of mepolizumab
- Only GAN questionnaire antibody version cohort: No blood eosinophil measurement† recorded in the database (current or last two years)
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2022-01-06
Actual study completion date
2022-01-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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