About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or eligible female participants
Participants with >=40 to less than or equal to (<=) 80 years of age.
An eosinophilic phenotype with elevated BEC.
Moderate to very severe COPD with frequent exacerbations.
Disqualifiers
Current or prior physician diagnosis of asthma
Other clinically significant lung disease.
Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.
Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure.
Trial design
Parallel
Treatments tested in this trial
GSK5784283
DrugGSK5784283 will be administered.
Placebo
DrugPlacebo will be administered.
Standard of care
DrugStandard of care will be administered.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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