Trial · NCT03511105
Effects of GSK2798745 on Alveolar Barrier Disruption in a Segmental Lipopolysaccharide (LPS) Challenge Model
NCT03511105, Phase 1, Terminated, GlaxoSmithKline; results first posted 2020-02-05
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Effects of GSK2798745 on Alveolar Barrier Disruption in a Segmental Lipopolysaccharide (LPS) Challenge Model. Trials, record NCT03511105. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03511105
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of GSK2798745 on Alveolar Barrier Disruption in a Segmental Lipopolysaccharide (LPS) Challenge Model
- NCT number
- NCT03511105
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 47 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Healthy Volunteers
- Interventions
- GSK2798745, Placebo, Lipoplysaccharide from Escherichia Coli, Saline
- First posted
- 2018-04-27
- Last updated
- 2021-03-29
- Other registries' IDs
- eudract:2017-002388-16
- Results first posted
- 2020-02-05
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Baseline Adjusted Total Protein Concentration in Broncho-alveolar (BAL) Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose) | Baseline and at 26 hours post-first dose | Participants underwent segmental challenge to lungs, via bronchoscopy, at 2 hours after first dose of investigational medicinal product. BAL samples were taken, via bronchoscopy and total protein was measured. Baseline (2 hours) samples were taken immediately before the LPS and saline challenges, from a segment in the left lower lobe, and post-challenge samples were taken at 24 hours (26 hours post-first dose) after the LPS and saline challenges, from the challenged segments. Evaluable Population consists of all participants for whom results of the primary analysis can be determined i.e. all randomized participants who received two correct doses of study treatment, received LPS and saline segmental challenge (in contralateral lobes) and for which results of both baseline (2 hours) and LPS lobe (26 hours) BAL samples are evaluable. This population will be based on treatment the participant actually received. Median and 95% credible interval (CrI) has been presented. |
| Secondary | Baseline Adjusted Total Cell Count of Neutrophils in BAL Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose) | Baseline and at 26 hours post-first dose | Participants underwent segmental challenge to the lungs, via bronchoscopy, at 2 hours (Baseline) after the first dose of investigational medicinal product. BAL samples were taken, via bronchoscopy and total neutrophil cell count was measured. Baseline samples were taken immediately before the LPS and saline challenges, from a segment in the left lower lobe, and post-challenge samples were taken at 24 hours (26 hours post-first dose) after the LPS and saline challenges, from the challenged segments. Median and 95% CrI at indicated time point has been presented. |
| Secondary | Baseline Adjusted Differential Cell Count of Neutrophils in BAL Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose) | Baseline and at 26 hours post-first dose | Participants underwent segmental challenge to the lungs, via bronchoscopy, at 2 hours after the first dose of investigational medicinal product. BAL samples were taken, via bronchoscopy and total neutrophil cell count was measured. Baseline samples were taken immediately before the LPS and saline challenges, from a segment in the left lower lobe, and post-challenge samples were taken at 24 hour (26 hours post-first dose) after the LPS and saline challenges, from the challenged segments. Median and 95% CrI at the indicated time point has been presented. |
| Secondary | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Up to Day 9 (FU/EW) | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect and other important medical events. All Subjects Population consists of all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant actually received. SAEs and non-SAEs were analyzed up to follow-up or early withdrawal (FU/EW) of Day 9. |
| Secondary | Change From Baseline Values for Clinical Chemistry Parameters | Baseline (Day -1) and at Day 2 and Day 9 (FU/EW) | Blood samples were collected for the analysis of clinical chemistry parameters including alkaline phosphate (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine kinase (CK). Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Secondary | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine | Baseline (Day -1) and at Day 2 and Day 9 (FU/EW) | Blood samples were collected for the analysis of clinical chemistry parameters direct bilirubin, total bilirubin and creatinine. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Secondary | Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Baseline (Day -1) and at Day 2 and Day 9 (FU/EW) | Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium, sodium and urea/BUN. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Secondary | Change From Baseline Values for Clinical Chemistry Parameter-C Reactive Protein (CRP) | Baseline (Day -1) and at Day 2 and Day 9 (FU/EW) | Blood samples were collected for the analysis of clinical chemistry parameter- CRP. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Secondary | Change From Baseline Values for Clinical Chemistry Parameter-Total Protein | Baseline (Day -1) and at Day 2 and Day 9 | Blood samples were collected for the analysis of clinical chemistry parameter- total protein. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Secondary | Change From Baseline Values for Hematology Parameters | Baseline (Day -1) and at Day 2 and Day 9 (FU/EW) | Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell (WBC) count. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Baseline Adjusted Total Protein Concentration in Broncho-alveolar (BAL) Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose) | Baseline and at 26 hours post-first dose | Evaluable Population. | Milligrams per liter | MEDIAN |
| SECONDARY | Baseline Adjusted Total Cell Count of Neutrophils in BAL Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose) | Baseline and at 26 hours post-first dose | Evaluable Population. | 10^6 cells per milliliter | MEDIAN |
| SECONDARY | Baseline Adjusted Differential Cell Count of Neutrophils in BAL Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose) | Baseline and at 26 hours post-first dose | Evaluable Population. | Percentage of total cell count | MEDIAN |
| SECONDARY | Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Up to Day 9 (FU/EW) | All Subjects Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline Values for Clinical Chemistry Parameters | Baseline (Day -1) and at Day 2 and Day 9 (FU/EW) | All Subjects Population. | International units per liter | MEAN |
| SECONDARY | Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine | Baseline (Day -1) and at Day 2 and Day 9 (FU/EW) | All Subjects Population. | Micromoles per liter | MEAN |
| SECONDARY | Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Baseline (Day -1) and at Day 2 and Day 9 (FU/EW) | All Subjects Population. | Millimoles per liter | MEAN |
| SECONDARY | Change From Baseline Values for Clinical Chemistry Parameter-C Reactive Protein (CRP) | Baseline (Day -1) and at Day 2 and Day 9 (FU/EW) | All Subjects Population. | Milligrams per liter | MEAN |
| SECONDARY | Change From Baseline Values for Clinical Chemistry Parameter-Total Protein | Baseline (Day -1) and at Day 2 and Day 9 | All Subjects Population. | Grams per liter | MEAN |
| SECONDARY | Change From Baseline Values for Hematology Parameters | Baseline (Day -1) and at Day 2 and Day 9 (FU/EW) | All Subjects Population. | Giga cells per liter | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group206
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Baseline Adjusted Total Protein Concentration in Broncho-alveolar (BAL) Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose) | Placebo | 348.46 | 95% Confidence Interval 285.97 to 425.67 | Milligrams per liter | |
| Baseline Adjusted Total Protein Concentration in Broncho-alveolar (BAL) Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose) | GSK2798745 | 318.43 | 95% Confidence Interval 260.18 to 389.98 | Milligrams per liter | |
| Baseline Adjusted Total Cell Count of Neutrophils in BAL Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose) | Placebo | 58.94 | 95% Confidence Interval 42.70 to 81.42 | 10^6 cells per milliliter | |
| Baseline Adjusted Total Cell Count of Neutrophils in BAL Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose) | GSK2798745 | 54.63 | 95% Confidence Interval 39.21 to 75.90 | 10^6 cells per milliliter | |
| Baseline Adjusted Differential Cell Count of Neutrophils in BAL Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose) | Placebo | 58.57 | 95% Confidence Interval 54.37 to 63.09 | Percentage of total cell count | |
| Baseline Adjusted Differential Cell Count of Neutrophils in BAL Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose) | GSK2798745 | 58.54 | 95% Confidence Interval 54.22 to 63.12 | Percentage of total cell count | |
| Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Placebo | Any SAE | 0 | Participants | |
| Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | GSK2798745 | Any SAE | 0 | Participants | |
| Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | Placebo | Any non-SAE | 10 | Participants | |
| Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs | GSK2798745 | Any non-SAE | 7 | Participants |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | STARTED | GSK2798745 | 22 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | COMPLETED | GSK2798745 | 22 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | GSK2798745 | 0 |
Source ClinicalTrials.gov
Adverse events6
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 |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Placebo | 5 | 25 | 5 |
| other | Headache | Nervous system disorders | GSK2798745 | 4 | 22 | 4 |
| other | Pyrexia | General disorders | Placebo | 3 | 25 | 3 |
| other | Pyrexia | General disorders | GSK2798745 | 4 | 22 | 5 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 25 | 3 |
| other | Nasopharyngitis | Infections and infestations | GSK2798745 | 0 | 22 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 25 |
| Total, all-cause mortality | GSK2798745 | 0 | 22 |
| Total, other adverse events | Placebo | 10 | 25 |
| Total, other adverse events | GSK2798745 | 7 | 22 |
| Total, serious adverse events | Placebo | 0 | 25 |
| Total, serious adverse events | GSK2798745 | 0 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33189900 | BACKGROUND |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK2798745 vs Placebo: Number of Participants With Positive Fecal Occult Blood Test (FOBT) Data | Trial comparisons |
| GSK2798745 vs Placebo: deaths from any cause | Trial comparisons |
| GSK2798745 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03511105
GET https://conductscience.org/api/trials/v1/NCT03511105/registered?page=2