Last updated: 12/02/2024 09:50:22

Evaluation of Findings and Healthcare Resource Utilization (HCRU) in Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Treated with Mepolizumab

GSK study ID
217530
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluation of Clinical Outcomes and Healthcare Resource Utilization (HCRU) in Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Treated with Mepolizumab
Trial description: The primary purpose of the study is to characterize and to evaluate changes in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)-related Healthcare Resource Utilization (HCRU) (outpatient, specialist, and emergency department [ED] visits) during both the six- and 12-month baseline periods and six-month follow-up period in participants with CRSwNP who initiated mepolizumab.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Participants with CRSwNP-related outpatient visits during 6-months baseline period

Timeframe: At 6 months before mepolizumab initiation

Number of Participants with CRSwNP-related outpatient visits during 12-months baseline period

Timeframe: At 12 months before mepolizumab initiation

Number of Participants with CRSwNP-related outpatient visits during 6-months Follow-up period

Timeframe: Up to 6 months after mepolizumab initiation

Number of Participants with CRSwNP-related specialist visits before 6-months baseline period

Timeframe: At 6 months before mepolizumab initiation

Number of Participants with CRSwNP-related specialist visits before 12-months baseline period

Timeframe: At 12 months before mepolizumab initiation

Number of Participants with CRSwNP-related specialist visits during 6-months Follow-up period

Timeframe: Up to 6 months after mepolizumab initiation

Number of Participants with CRSwNP-related emergency department (ED) visits before 6-months Baseline period

Timeframe: At 6 months before mepolizumab initiation

Number of Participants with CRSwNP-related ED visits before 12-months Baseline period

Timeframe: At 12 months before mepolizumab initiation

Number of Participants with CRSwNP-related ED visits during 6-months Follow-up period

Timeframe: Up to 6 months after mepolizumab initiation

Secondary outcomes:

Change in Charlson Comorbidity Index During Full Baseline Period

Timeframe: 12 months before mepolizumab initiation

Number of Participants with Nasal Endoscopy

Timeframe: At 6 and 12 months before mepolizumab initiation and 6 months after mepolizumab initiation

Number of Participants with Sinus computed tomography (CT) scan

Timeframe: 6 months before mepolizumab initiation

Number of Participants with Sinus Magnetic Resonance Imaging (MRI)

Timeframe: 6 months before mepolizumab initiation

Number of Participants with Sinus computed tomography (CT) scan

Timeframe: 12 months before mepolizumab initiation and up to 6 months after mepolizumab initiation

Number of Participants with Sinus Magnetic Resonance Imaging (MRI)

Timeframe: 12 months before mepolizumab initiation and up to 6 months after mepolizumab initiation

Number of Participants with Endoscopic Sinus Surgery (ESS)

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participants with Sinus debridement

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participants with Polypectomy

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participants prescribed with oral corticosteroid

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participants prescribed with Intranasal corticosteroid

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participants prescribed with oral antibiotic

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participants with CRSwNP-related Nasal Obstruction

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participants with CRSwNP-related Nasal Discharge

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participants with CRSwNP-related Facial Pain or Pressure

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participants with CRSwNP-related Loss of Sense of Smell

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participant prescribed with Inhaled anticholinergics for Asthma

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participant prescribed with Inhaled corticosteroids (ICS) for Asthma

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participant prescribed with Inhaled long-acting beta-agonists (LABA) for Asthma

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participant prescribed with Inhaled short-acting beta-agonists (SABA) for Asthma

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participant prescribed with Leukotriene modifiers for Asthma

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participant prescribed with Theophylline for Asthma

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participant prescribed with Cromolyn for Asthma

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participant prescribed with Cromolyn for Asthma

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participant prescribed with Oral albuterol for Asthma

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participant prescribed with ICS or LABA for Asthma

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participant prescribed with SABA or Short-acting muscarinic-antagonist (SAMA) for Asthma

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Number of Participant with all-cause Outpatient, Specialist and Emergency Department (ED) Visit

Timeframe: 12 months, 6 months before mepolizumab initiation and up to 12 months after mepolizumab initiation

Interventions:
Not applicable
Enrollment:
218
Primary completion date:
2024-09-05
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Nasal Polyps
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
October 2023 to May 2024
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Initiation of mepolizumab on or after 29 July 2021 (index date).
  • Have available Electronic Medical Record (EMR) and claims data for at least 12 months before and at least 6 months after the index date, with a specialist EMR encounter during the 12-month baseline period.
  • None
Inclusion and exclusion criteria
Inclusion criteria:

    Initiation of mepolizumab on or after 29 July 2021 (index date).

    • Have available Electronic Medical Record (EMR) and claims data for at least 12 months before and at least 6 months after the index date, with a specialist EMR encounter during the 12-month baseline period.
    • Have at least one CRS-associated NP diagnosis during the 12 months prior to or on the index date.
Exclusion criteria:
  • None

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2024-09-05
Actual study completion date
2024-09-05

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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