Last updated: 09/25/2025 12:40:10

REALITI-C: Real world effectiveness of mepolizumab in treating chronic obstructive pulmonary disease (COPD)

GSK study ID
223598
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: REAL-world Effectiveness of Mepolizumab In TreaTIng Chronic Obstructive Pulmonary Disease: A Multi-Country Prospective Study (REALITI-C)
Trial description: The aim of this study is to generate insights into the real-world effectiveness of mepolizumab in participants with COPD.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Annualized rate of moderate/severe exacerbations

Timeframe: 12 months pre-exposure period and 12 months following mepolizumab initiation

Secondary outcomes:

Change from baseline in St. Georges Respiratory Questionnaire for COPD Patients (SGRQ-C) total score

Timeframe: Baseline and 3, 6, 12, 24, and 36 months following mepolizumab initiation

Change from baseline in COPD Assessment Test (CAT) total score

Timeframe: Baseline and 3, 6, 12, 24, and 36 months following mepolizumab initiation

Annualized rate of moderate/severe exacerbations

Timeframe: 12-month pre-exposure period and 24 and 36 months following mepolizumab initiation

Time to first moderate/severe exacerbation

Timeframe: 12, 24 and 36 months following mepolizumab initiation

Annualized rate of severe exacerbations

Timeframe: 12-month pre-exposure period and 12, 24, and 36 months following mepolizumab initiation

Change from baseline in forced expiratory volume in 1 second (FEV1)

Timeframe: Baseline and 6, 12, 24, and 36 months following mepolizumab initiation

Percentage of participants achieving composite endpoint defined based on multiple individual clinical measures

Timeframe: At 6, 12, 24, and 36 months following mepolizumab initiation

Number of mepolizumab injections

Timeframe: Up to 36 months following mepolizumab initiation

Medication possession ratio of mepolizumab treatment

Timeframe: Up to 36 months following mepolizumab initiation

Proportion of days covered of mepolizumab treatment

Timeframe: Up to 36 months following mepolizumab initiation

Time to mepolizumab treatment discontinuation

Timeframe: Up to 36 months following mepolizumab initiation

Annualized rate of COPD exacerbations requiring emergency department (ED) visit and/or hospitalization

Timeframe: 12 months pre-exposure period and 12, 24, and 36 months following mepolizumab initiation

COPD-related healthcare resource use, including annualized rates of hospitalizations, ED visits, and clinic/outpatient visits, and prescription medication use

Timeframe: 12 months pre-exposure period and 12, 24, and 36 months following mepolizumab initiation

Time to first COPD-related hospitalization

Timeframe: 12, 24, and 36 months following mepolizumab initiation

Time to first COPD-related ED visit

Timeframe: 12, 24, and 36 months following mepolizumab initiation

Change in exposure to systemic corticosteroid

Timeframe: Baseline and 6, 12, 24, and 36 months following mepolizumab initiation

Interventions:
Not applicable
Enrollment:
682
Primary completion date:
2030-23-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
July 2025 to November 2030
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • Participant is >=40 years of age at enrollment
  • Participant has had a documented diagnosis of COPD for at least 12 months, as per physician’s judgment
  • Participant has received mepolizumab for treating COPD more than 7 days prior to the enrollment
  • Participant has received mepolizumab for indications other than COPD anytime within 12 months prior to the enrollment.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Naples, FL, United States, 34102
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Gainesville, FL, United States, 32607
Status
Recruiting
Location
GSK Investigational Site
Sewell, NJ, United States, 08080
Status
Recruiting
Location
GSK Investigational Site
Anderson, SC, United States, 29621
Status
Recruiting
Location
GSK Investigational Site
Orlando, FL, United States, 32803
Status
Recruiting
Location
GSK Investigational Site
Rock Hill, SC, United States, 29732
Status
Recruiting
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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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