Last updated: 03/04/2025 06:40:21
A study on Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) to Assess Participant’s Quality of Life While on Mepolizumab Treatment
GSK study ID
219749
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: MOZART – A Prospective, Observational, Multi-center Study in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) To Assess the Effectiveness of Mepolizumab Treatment and the Resulting Improvement of Patient’s Quality of Life in a Routine Clinical Setting in Austria
Trial description: This is a multicenter, single arm, prospective observational study conducted in Austria on participants with CRSwNP. The primary objective of the study is the assessment of clinically relevant change in chronic rhinosinusitis symptoms after 12 months of mepolizumab treatment.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants achieving a reduction of greater than or equal to (≥) 8.9 points in the total Sino-Nasal Outcome Test (SNOT)-22 score
Timeframe: Baseline (Day 0) and 12-month
Secondary outcomes:
Percentage of participants achieving a reduction of ≥ 8.9 points in the total SNOT-22 score
Timeframe: Baseline, 3-month, 6-month, and 18-month
Change from Baseline in SNOT-22 scores
Timeframe: Baseline, 3-month, 6-month, 12-month, and 18-month
Change from Baseline in Nasal Polyp Score (NPS)
Timeframe: Baseline, 3-month, 6-month, 12 month, and 18-month
Change from Baseline in rhinorrhea, post-nasal drip and nasal congestion
Timeframe: Baseline, 3-month, 6-month, 12-month, and 18-month
Change from Baseline in improvement of smell dysfunction
Timeframe: Baseline, 3-month, 6-month, 12 month, and 18-month
Interventions:
Not applicable
Enrollment:
80
Primary completion date:
2026-30-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Nasal Polyps
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
November 2024 to August 2026
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Adult participants with an investigator’s primary diagnosis of severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) that cannot be adequately controlled with systemic corticosteroids and/or surgical intervention.
- Treatment according to the current Summary of Product Characteristics (SmPC)
- Comorbid moderate to severe asthma (Global Initiative for Asthma [GINA] step 3-5)
- Surgery of nasal polyps in the last six months and/or already planned during first 6 months of observation period
Inclusion and exclusion criteria
Inclusion criteria:
- Adult participants with an investigator’s primary diagnosis of severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) that cannot be adequately controlled with systemic corticosteroids and/or surgical intervention.
- Treatment according to the current Summary of Product Characteristics (SmPC)
- The participant’s written informed consent to direct access and data processing must be obtained.
Exclusion criteria:
- Comorbid moderate to severe asthma (Global Initiative for Asthma [GINA] step 3-5)
- Surgery of nasal polyps in the last six months and/or already planned during first 6 months of observation period
- Previous or ongoing therapy with other biologics for treatment of CRSwNP (approved: dupilumab, omalizumab; potential off-label use: benralizumab, reslizumab, tezepelumab)
- Any condition that
- in the treating physician’s opinion
- would negatively influence the effectiveness of the treatment
- Participation in a Phase I – IV clinical trial 4 weeks before start of mepolizumab up to the end of the observation period
Trial location(s)
This study does not involve prospective enrollment of participants.
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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