Last updated: 11/05/2025 16:30:12
A post-marketing surveillance study in participants with chronic rhinosinusitis with nasal polyps
GSK study ID
223525
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: Nucala pre-filled pen Nucala pre-filled syringe Drug Use Investigation (Chronic Rhinosinusitis with Nasal Polyps)
Trial description: This study is conducted to collect and evaluate information on the safety and efficacy of NUCALA pre-filled pen and NUCALA pre-filled syringe (Hereinafter referred to as NUCALA) in routine clinical use in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) (Hereinafter referred to as CRSwNP). NUCALA is a registered trademark of GSK group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse drug reactions (ADRs)
Timeframe: Up to Week 52
Secondary outcomes:
Response rate based on the global assessment of effectiveness
Timeframe: At Weeks 24 and 52
Change from Baseline in the size of nasal polyps after treatment with NUCALA
Timeframe: Baseline and at Weeks 24 and 52
Change from Baseline in Sino-Nasal Outcome Test (SNOT-22) total score
Timeframe: Baseline and at Weeks 12, 24, and 52
Change from Baseline in Asthma Control Test (ACT) total score
Timeframe: Baseline and at Weeks 12, 24, and 52
Interventions:
Not applicable
Enrollment:
40
Primary completion date:
2028-31-01
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)
April 2025 to January 2028
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
15+ years
Accepts healthy volunteers
No
- Participants who were diagnosed with CRSwNP (limited to participants who have had an inadequate response to conventional treatments), the indication of this drug, and received NUCALA for the first time.
- Obtain informed consent from participants who prescribed NUCALA for the first time.
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Obtain informed consent from participants who prescribed NUCALA for the first time.
Participants who were diagnosed with CRSwNP (limited to participants who have had an inadequate response to conventional treatments), the indication of this drug, and received NUCALA for the first time.
Exclusion criteria:
Not applicable
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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