A Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT07915791, Phase 2, Not yet recruiting, GlaxoSmithKline
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study to Assess the Efficacy and Safety of Co-administration of GSK3862995B With GSK5784283 in Adult Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | ClinicalTrials.gov |
| NCT number | NCT07915791 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 279 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | GlaxoSmithKline | ClinicalTrials.gov |
| Conditions | Pulmonary Disease, Chronic Obstructive | ClinicalTrials.gov |
| Interventions | GSK3862995B, GSK5784283, Placebo | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Annualized Rate of Moderate/severe Exacerbations in Former Smokers | Up to 72 weeks | A moderate exacerbation is defined as a clinically significant exacerbation that requires treatment with oral/systemic corticosteroids and/or antibiotics. A severe exacerbation is defined as a clinically significant exacerbation that that requires in-patient hospitalization or results in death. The annualized rate will be derived using exacerbations data collected during the study for former smokers. | ClinicalTrials.gov |
| Secondary | Number of Participants with Serious Adverse Events and Adverse Events in All Comers (Former and Current smokers) with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | Up to 120 weeks | ClinicalTrials.gov | |
| Secondary | Number of Participants with Clinically Significant Changes from Baseline in Clinical Laboratory Parameters, Vital Signs, and 12-Lead Electrocardiogram (ECG) in All Comers (Former and Current smokers) with Moderate to Severe COPD | Up to 120 weeks | ClinicalTrials.gov | |
| Secondary | Time to First Exacerbation in Former Smokers with Moderate to Severe COPD | Up to 72 weeks | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) at Week 24 in Former Smokers with Moderate to Severe COPD | Baseline and Week 24 | ClinicalTrials.gov | |
| Secondary | Change from Baseline in SGRQ-C total score at Week 24 in Former Smokers with Moderate and Severe COPD | Baseline and Week 24 | The SGRQ C is a validated, disease specific patient reported outcome instrument used to assess health related quality of life in patients with chronic obstructive pulmonary disease (COPD), capturing the impact of respiratory symptoms, activity limitations, and psychosocial effects of the disease. It calculates domain scores (Symptoms, Activity, and Impacts) and an overall Total Score based on weighted responses to approximately 40 questionnaire items, which yield to a score ranges from 0 (no impairment; best health status) to 100 (maximum impairment; worst health status). | ClinicalTrials.gov |
| Secondary | Change from baseline in the COPD Assessment Test (CAT) Score at Week 24 in Former Smokers with Moderate to Severe Smokers | Baseline and Week 24 | The CAT is a short, patient-completed questionnaire developed to measure the health status of individuals with Chronic Obstructive Pulmonary Disease (COPD). The CAT consists of 8 items, and for each item, the participant provides a rating on a 6-point scale from 0 (representing no impairment) to 5 (representing maximum impairment). A total score is derived by summing the scores of the 8 items, resulting in a scoring range of 0 to 40. Higher scores indicate a greater impact of the disease on the participants health. | ClinicalTrials.gov |
| Secondary | Change from baseline in the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) score at Week 24 in Former Smokers with Moderate to Severe COPD | Baseline and Week 24 | The E-RS: COPD is a patient-reported outcome diary developed to measure the severity of respiratory symptoms in patients with stable COPD. It consists of 11 respiratory symptom items from the 14-item EXAcerbations of Chronic pulmonary disease Tool (EXACT). Participants complete the diary each evening, rating their symptoms for that day. The E-RS: COPD total score is calculated by summing the responses to the 11 items, with a scoring range of 0 to 40. Higher scores indicate more severe respiratory symptoms. The instrument also includes three subscales: Breathlessness (5 items; score range 0-17), Cough and Sputum (3 items; score range 0-11), and Chest Symptoms (3 items; score range 0-12). The E-RS: COPD is designed to capture symptoms such as breathlessness, cough, sputum production, chest congestion, and chest tightness. | ClinicalTrials.gov |
| Secondary | Annualized rate of Moderate/Severe Exacerbations in all Comers (Former and Current smokers) | Up to 72 weeks | A moderate exacerbation is defined as a clinically significant exacerbation that requires treatment with oral/systemic corticosteroids and/or antibiotics. A severe exacerbation is defined as a clinically significant exacerbation that that requires in-patient hospitalization or results in death. The annualized rate will be derived using exacerbations data collected during the study for former smokers. | ClinicalTrials.gov |
| Secondary | Time to First Exacerbation in all Comers (Former and current Smokers) with Moderate to Severe COPD | Up to 72 weeks | ClinicalTrials.gov | |
| Secondary | Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) at Week 24 in all comers (Former and Current Smokers) with Moderate to Severe COPD | Baseline and Week 24 | ClinicalTrials.gov | |
| Secondary | Change from Baseline in SGRQ-C total score at Week 24 in all Comers (Former and Current Smokers) with Moderate and Severe COPD | Baseline and Week 24 | The SGRQ C is a validated, disease specific patient reported outcome instrument used to assess health related quality of life in patients with chronic obstructive pulmonary disease (COPD), capturing the impact of respiratory symptoms, activity limitations, and psychosocial effects of the disease. It calculates domain scores (Symptoms, Activity, and Impacts) and an overall Total Score based on weighted responses to approximately 40 questionnaire items, which yield to a score ranges from 0 (no impairment; best health status) to 100 (maximum impairment; worst health status). | ClinicalTrials.gov |
| Secondary | Change from baseline in the CAT Score at Week 24 all Comers (Former and Current Smokers) with Moderate to Severe Smokers | Baseline and Week 24 | The CAT is a short, patient-completed questionnaire developed to measure the health status of individuals with Chronic Obstructive Pulmonary Disease (COPD). The CAT consists of 8 items, and for each item, the participant provides a rating on a 6-point scale from 0 (representing no impairment) to 5 (representing maximum impairment). A total score is derived by summing the scores of the 8 items, resulting in a scoring range of 0 to 40. Higher scores indicate a greater impact of the disease on the participants health. | ClinicalTrials.gov |
| Secondary | Change from baseline in the Evaluating Respiratory Symptoms in COPD (E-RS: COPD) score at Week 24 in all comers (Former and current Smokers) with Moderate to Severe COPD | Baseline and Week 24 | The E-RS: COPD is a patient-reported outcome diary developed to measure the severity of respiratory symptoms in patients with stable COPD. It consists of 11 respiratory symptom items from the 14-item EXAcerbations of Chronic pulmonary disease Tool (EXACT). Participants complete the diary each evening, rating their symptoms for that day. The E-RS: COPD total score is calculated by summing the responses to the 11 items, with a scoring range of 0 to 40. Higher scores indicate more severe respiratory symptoms. The instrument also includes three subscales: Breathlessness (5 items; score range 0-17), Cough and Sputum (3 items; score range 0-11), and Chest Symptoms (3 items; score range 0-12). The E-RS: COPD is designed to capture symptoms such as breathlessness, cough, sputum production, chest congestion, and chest tightness. | ClinicalTrials.gov |
| Secondary | Serum concentrations of GSK3862995B and GSK5784283 in all comers (former and current smokers) with moderate to severe COPD | Week 2; pre-dose on Weeks 12, 24, 36, 48, 60; and Week 72 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
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Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)