Last updated: 05/22/2025 03:50:46
United States (US)- Nucala impact on Sino-nasal Outcome Test (SNOT-22)
GSK study ID
218956
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Retrospective Chart Review to Assess the Real-World Effectiveness of Mepolizumab (Nucala) among Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in the US
Trial description: The purpose of the study is to evaluate the real-world effectiveness of mepolizumab (Nucala) by assessing clinical endpoints, medication use, and Patient-Reported Outcomes (PROs) pre- vs. post-mepolizumab initiation among adult participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in the United States (US).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Cumulative dose (milligrams prednisone equivalent) per person per year (PPPY)
Timeframe: Up to 24 months
Average daily dose (milligrams prednisone equivalent) per prescription
Timeframe: Up to 24 months
Rate of OCS use for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) PPPY
Timeframe: Up to 24 months
Proportion of participants with Oral Corticosteroid (OCS) use for CRSwNP
Timeframe: Up to 24 months
Proportion of participants short-term OCS burst for CRSwNP,
Timeframe: Up to 24 months
Mean number of OCS bursts
Timeframe: Up to 24 months
Proportion of participants with chronic OCS use for CRSwNP
Timeframe: Up to 24 months
Secondary outcomes:
Rate of surgical interventions for CRSwNP (overall and by type) PPPY
Timeframe: Up to 24 months
Proportion of participants with surgical interventions for CRSwNP (overall and by type)
Timeframe: Up to 24 months
Mean number of surgical interventions for CRSwNP (overall and by type)
Timeframe: Up to 24 months
Rate of CRSwNP medication use PPPY
Timeframe: Up to 24 months
Proportion of participants with CRSwNP-related medication use
Timeframe: Up to 24 months
Mean number of CRSwNP symptoms
Timeframe: Up to 24 months
Proportion of participants with each CRSwNP symptom
Timeframe: Up to 24 months
Change in each CRSwNP symptom status
Timeframe: Up to 24 months
Mean Nasal Polyp Score (NPS)
Timeframe: Up to 24 months
Proportion of Participants with Nasal polyp (NP) burden between pre- vs. post-mepolizumab initiation of less than or equal to (≤) -1
Timeframe: Up to 24 months
Proportion of participants with mild, moderate, and severe nasal polyps (NP) burden based on descriptive text
Timeframe: Up to 24 months
Rate of NP-related exacerbations PPPY
Timeframe: Up to 24 months
Proportion of participants with NP-related exacerbations
Timeframe: Up to 24 months
Mean Sino-nasal Outcome Test (SNOT-22) scores
Timeframe: Up to 24 months
Proportion of participants with clinically significant difference in SNOT-22 scores between pre- vs. post-mepolizumab initiation of greater than or equal to (≥) -8.95
Timeframe: Up to 24 months
Mean Asthma Control Test (ACT) scores
Timeframe: Up to 24 months
Proportion of participants with clinically significant difference in ACT scores between pre- vs. post-mepolizumab initiation of ≥ 3
Timeframe: Up to 24 months
Interventions:
Not applicable
Enrollment:
200
Primary completion date:
2025-03-03
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)
July 2024 to March 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participant Inclusion Criteria
- Physician documented diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) prior to or on the index date
- Diagnosis of antrochoanal polyps, head and neck cancer, or cystic fibrosis during the baseline period
Inclusion and exclusion criteria
Inclusion criteria:
- Physician documented diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) prior to or on the index date
- At least one prescription or administration of mepolizumab (100 milligrams [mg] dose) for the treatment of CRSwNP between July 29, 2021, and December 31, 2022
- At least one prescription or administration of mepolizumab (100 mg dose) for the treatment of CRSwNP in the first 3 months after the index date
- At least 12 months of medical records before the index date (that is, at least 1 visit, in-person or virtual, that occurred at least 12 months before the index date)
- At least 12 months of medical records since the index date (i.e., at least 1 visit, in-person or virtual, that occurred at least 12 months since the index date), except if participant died
Participant Inclusion Criteria
Exclusion criteria:
- Diagnosis of antrochoanal polyps, head and neck cancer, or cystic fibrosis during the baseline 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
Study complete
Actual primary completion date
2025-03-03
Actual study completion date
2025-03-03
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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