REALITI-C: Real world effectiveness of mepolizumab in treating chronic obstructive pulmonary disease (COPD)
Trial overview
Annualized rate of moderate/severe exacerbations
Timeframe: 12 months pre-exposure period and 12 months following mepolizumab initiation
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
Participation criteria
- 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.
- Participant has had a documented diagnosis of COPD for at least 12 months, as per physician’s judgment
- Confirmed availability of medical records for at least 12 months prior to inclusion in the study
- Participant has newly initiated treatment with add-on mepolizumab for COPD with an eosinophilic phenotype or characterized by raised blood eosinophils (as per the country-specific label for COPD). Physician’s decision to treat the participant with add-on mepolizumab was made independently of the participants participation in this study (as per Standard of Care)
- Participant has been on maintenance inhaled therapy for a minimum of 3 months prior to enrollment
- Participant is willing and able to complete study-related questionnaires
- Participant provides voluntary signed informed consent to participate in the study before inclusion in the study
Participant is >=40 years of age at enrollment
- Participant has received mepolizumab for indications other than COPD anytime within 12 months prior to the enrollment.
- Participant has a documented history of failure with anti- Interleukin (IL)-5/5 receptor (r) therapy, per physician judgment, for any indication
- Participant has any condition that—in the opinion of the investigator—may interfere with the participants ability to participate in the study (such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the participant from completing visits and assessments
- Participant currently participates in any interventional clinical trial
Participant has received mepolizumab for treating COPD more than 7 days prior to the enrollment
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.