Last updated: 04/02/2025 10:00:17
A Study for the Effect of Mepolizumab in Participants with Chronic Rhinosinusitis with Nasal Polyps and Asthma
GSK study ID
218616
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: RESPONSE: REal world non-interventional prospective multi-country Study of mePOlizumab in patients with chronic rhinosinusitis with Nasal polyposis and asthma or Severe Eosinophilic asthma and nasal polyps
Trial description: This study is an observational, multi-centre prospective cohort study. The study will be conducted in adult participants with a confirmed primary diagnosis of either Severe eosinophilic asthma (SEA) with comorbid nasal polyposis (NP) or Chronic rhinosinusitis with nasal polyposis (CRSwNP) with comorbid asthma in a real-world setting.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Mean Change from Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) at 12 Months
Timeframe: At baseline and 12 months
Secondary outcomes:
Mean Change from Baseline in SNOT-22 from Baseline at 1, 3, and 6 Months
Timeframe: At baseline, 1, 3 and 6 months
Mean Change from Baseline in Visual Analogue Scale (VAS) Score for Smell Dysfunction and Nasal Obstruction at 1, 3, 6, and 12 Months
Timeframe: At baseline, 1, 3, 6 and 12 months
Change from Baseline in NP Score, per Nasal Endoscopy and/or Computed Tomography (CT) Scan at 1, 3, 6, and 12 Months
Timeframe: At baseline, 1, 3, 6 and 12 months
Annualised Rate in Clinically Significant Asthma Exacerbations
Timeframe: 12 months pre-dose and 12 months post-dose
Mean Change from Baseline in Asthma Control Questionnaire (ACQ)-5 from Baseline at 1, 3, 6, and 12 Months
Timeframe: At baseline, 1, 3, 6 and 12 months
Mean Change from Baseline in Asthma Quality of Life questionnaire (AQLQ) at 1, 3, 6, and 12 Months
Timeframe: At baseline, 1, 3, 6 and 12 months
Number of Participants with Changes in Dosing and Frequency of Mepolizumab Utilization
Timeframe: 12 months post-dose
Number of Participants with Treatment Interruptions/Cessation
Timeframe: 12 months post-dose
Number of Participants with Use of Concomitant Medications and Occurrence of Surgery
Timeframe: 12 months post-dose
Mean Percentage Reduction in Oral corticosteroids (OCS) Daily Dose for Participants Utilizing OCS
Timeframe: At baseline, 1, 3, 6 and 12 months post-dose
Proportion of Participants achieving OCS Cessation
Timeframe: At 1, 3, 6 and 12 months post-dose
Mean Change from Baseline in Rescue Medication Use
Timeframe: At baseline, 1, 3, 6 and 12 months post-dose
Interventions:
Enrollment:
208
Primary completion date:
2025-27-11
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
April 2024 to November 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participants with an investigator’s primary diagnosis of SEA with comorbid NP or CRSwNP with comorbid asthma
- Newly initiating add-on mepolizumab defined as 1) initiating mepolizumab up to 30 days before study enrolment (provided SNOT-22 and VAS scores for smell dysfunction and nasal obstruction has been collected 0 to 30 days before mepolizumab initiation) or 2) initiating mepolizumab up to 30 days after the study enrolment
- Current participation in an interventional study that includes treatment with an investigational drug and/or intervention at the same time as enrolment in the current study or within 6 months prior to initiating mepolizumab
- Diagnosis of eosinophilic granulomatosis with polyangiitis, cystic fibrosis, immunodeficiency, and primary ciliary dyskinesia, or any other condition that would make it difficult for the participant to fulfil the study criteria, per the investigator’s discretion
Inclusion and exclusion criteria
Inclusion criteria:
- Participants with an investigator’s primary diagnosis of SEA with comorbid NP or CRSwNP with comorbid asthma
- Newly initiating add-on mepolizumab defined as 1) initiating mepolizumab up to 30 days before study enrolment (provided SNOT-22 and VAS scores for smell dysfunction and nasal obstruction has been collected 0 to 30 days before mepolizumab initiation) or 2) initiating mepolizumab up to 30 days after the study enrolment
- Eligible for mepolizumab per local labelling requirements
- Written informed consent
- Participant must have access to a compatible device and internet access for Electronic patient reported outcome (ePRO) completion and be willing and able to comply with ePRO data collection
Exclusion criteria:
- Current participation in an interventional study that includes treatment with an investigational drug and/or intervention at the same time as enrolment in the current study or within 6 months prior to initiating mepolizumab
- Diagnosis of eosinophilic granulomatosis with polyangiitis, cystic fibrosis, immunodeficiency, and primary ciliary dyskinesia, or any other condition that would make it difficult for the participant to fulfil the study criteria, per the investigator’s discretion
- NP surgery scheduled to occur within 1 month after the enrolment visit
- NP surgery in the 6 months prior to the enrolment visit
- Pregnant or breastfeeding at the enrolment visit
Trial location(s)
Showing 1 - 6 of 10 Results
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Additional information
Not applicable
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