Last updated: 06/12/2025 07:20:15
Indirect Treatment Comparison (ITC) of Mepolizumab versus Relevant Comparators in Treating Chronic Obstructive Pulmonary Disease (COPD)
GSK study ID
223396
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Indirect Treatment Comparison (ITC) of Mepolizumab in Chronic Obstructive Pulmonary Disease (COPD)
Trial description: This study is aimed at assessing the comparative efficacy of mepolizumab compared to relevant comparators as add-on treatment in participants with COPD with an eosinophilic phenotype who experience frequent exacerbations despite receiving optimized inhaled therapy.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Annualized rate of moderate/severe exacerbations
Timeframe: Up to 52 weeks
Annualized rate of exacerbations leading to emergency department visit or hospitalization
Timeframe: Up to 52 weeks
Time to first moderate/severe exacerbation
Timeframe: Up to 52 weeks
Annualized rate of severe exacerbation
Timeframe: Up to 52 weeks
Difference in change from baseline (DCFB) in Saint George’s Respiratory Questionnaire (SGRQ) total score
Timeframe: At Week 52
SGRQ responder rate
Timeframe: At Week 52
DCFB in Evaluating Respiratory Symptom (ER-S):COPD total score
Timeframe: At Week 52
DCFB in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Timeframe: At Week 52
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2025-29-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
October 2024 to April 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Have a diagnosis of moderate to severe COPD who frequently exacerbate despite treatment with inhaled corticosteroid who frequently exacerbate despite treatment with inhaled corticosteroid (ICS)-based inhaled triple therapy
- Have type 2 inflammation characterized by an eosinophilic phenotype
- Airflow limitation: very severe airflow limitation at baseline
Inclusion and exclusion criteria
Inclusion criteria:
- Have a diagnosis of moderate to severe COPD who frequently exacerbate despite treatment with inhaled corticosteroid who frequently exacerbate despite treatment with inhaled corticosteroid (ICS)-based inhaled triple therapy
- Have type 2 inflammation characterized by an eosinophilic phenotype
- Have a blood eosinophil counts (BEC) >= 300 cells per (/) microliter (uL) at baseline
- Have chronic bronchitis at baseline
- Modified Medical Research Council Dyspnea Scale (mMRC) >= 2
Exclusion criteria:
- Airflow limitation: very severe airflow limitation at baseline
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
2025-29-04
Actual study completion date
2025-29-04
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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