The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to placebo in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
624
GSK5784283 will be administered.
Placebo will be administered.
Standard of care will be administered.
Annualized rate of moderate or severe COPD Exacerbations
Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to \[\>=\] 24 hours) or result in death.
Time frame: Up to Week 78
Change from Baseline in St. George's respiratory questionnaire (SGRQ) total score
SGRQ total score will be measured using the SGRQ for COPD (SGRQ-C). The SGRQ-C is a 14-item participant questionnaire, designed to measure health impairment by addressing the frequency of respiratory symptoms (questions 1-7) and the participant's current state (questions 8-14). The total score will be calculated on 0-100 rating scale and scores expressed as a percentage of overall impairment. Higher scores indicate greater impairment of health
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in pre-Bronchodilator Forced expiratory volume in 1 second (FEV1)
FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration as measured by spirometry.
Time frame: Baseline (Day 1) and at Week 52
Annualized rate of COPD exacerbations requiring emergency department (ED) visit or hospitalization
Annualized rate of COPD exacerbations requiring ED visit or hospitalization (For pooled analysis across studies 300629 and 300631) will be assessed.
Time frame: Up to Week 78
Annualized rate of moderate/severe COPD exacerbations among participants with elevated screening blood eosinophil counts (BEC)
Annualized rate of moderate/severe COPD exacerbations among participants with elevated screening BEC (For pooled analysis across studies 300629 and 300631) will be assessed.
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Time frame: Up to Week 78
Time to first moderate or severe COPD exacerbation
Time to first moderate or severe exacerbation (For pooled analysis across studies 300629 and 300631) will be assessed.
Time frame: Up to Week 78