Last updated: 12/09/2024 12:00:18
MEPOLYP: - Real-World Effectiveness of Mepolizumab with Severe Eosinophilic Asthma (SEA) and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: MEPOLYP: - Real-world effectiveness of MEpolizumab in patients with severe eosinophilic asthma and comorbid chronic rhinosinusitis with or without nasal POLYPs
Trial description: The aim of this multi-country study is to assess participant characteristics as well as treatment outcomes pre- and post-mepolizumab initiation in Severe Eosinophilic Asthma (SEA) participants with or without comorbid Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) from existing SEA registries.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change in Clinically Significant Asthma Exacerbations Rates with respect to Oral Corticosteroids [OCS] bursts for Participants With and Without Comorbid CRSwNP
Timeframe: At 12 months pre-dose and 12 months post-dose
Change in Clinically Significant Asthma Exacerbations Rates with respect to Emergency Room (ER) Visits for Participants With and Without Comorbid CRSwNP
Timeframe: At 12 months pre-dose and 12 months post-dose
Change in Clinically Significant Asthma Exacerbations Rates with respect to Hospitalizations for Participants With and Without Comorbid CRSwNP
Timeframe: At 12 months pre-dose and 12 months post-dose
Secondary outcomes:
Change in Rate of Asthma Exacerbations that Required Emergency Room (ER) Visits/ Hospitalization for Participants With and Without Comorbid CRSwNP
Timeframe: At 12 months pre-dose and 12 months post-dose
Change in Rate of Asthma Exacerbations that Required Hospitalization for Participants With and Without Comorbid CRSwNP
Timeframe: At 12 months pre-dose and 12 months post-dose
Change in Median Oral Corticosteroids [OCS] Maintenance Dose for Participants With and Without Comorbid CRSwNP
Timeframe: At 12 months pre-dose, 6 months and 12 months post-dose
Change in Forced Expiratory Volume in 1 Second (FEV1) Values for Participants With and Without Comorbid CRSwNP
Timeframe: At 12 months pre-dose, 6 months and 12 months post-dose
Change in Asthma Control Test (ACT) Scores for Participants With and Without Comorbid CRSwNP
Timeframe: At 12 months pre-dose, 6 months and 12 months post-dose
Demographic, Clinical and Disease Characteristics of Participants With and Without Comorbid CRSwNP
Timeframe: At 12 months pre-dose
Asthma Treatment Patterns (e.g., OCS, Inhaled Corticosteroids [ICS], Inhaled Treatments) Before Mepolizumab Initiation for Participants With and Without Comorbid CRSwNP
Timeframe: At 12 months pre-dose
Interventions:
Drug: Mepolizumab
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
2024-15-07
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
November 2023 to July 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participants should be able to sign Informed Consent
- Participants must have a current clinical diagnosis of SEA and can be either included in prior published material or newly enrolled into the registry
- Any mention of participation in an interventional clinical trial during the observational study period
Inclusion and exclusion criteria
Inclusion criteria:
- Participants should be able to sign Informed Consent
- Participants must have a current clinical diagnosis of SEA and can be either included in prior published material or newly enrolled into the registry
- Physician decision to prescribe treatment with mepolizumab
- Relevant records available for at least 12-months prior to index date and at least 12-months post-index date
Exclusion criteria:
- Any mention of participation in an interventional clinical trial during the observational study period
Trial location(s)
No location data available.
Study documents
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
Finalized
Actual primary completion date
2024-15-07
Actual study completion date
2024-15-07
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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