A Phase 1 interventional study of GSK3923868 and Placebo in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 1 site in Germany. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
This is a two parts study, a single ascending dose followed by 14-days repeat dosing. The single ascending dose part will assess two dose levels of GSK3923868 or placebo across two treatment periods 1 and 2 in a single cohort of participants with a washout period of a minimum of 5 days after each treatment periods. The repeat dose part will assess repeated one dose level of GSK3923868 or placebo in treatment period 3 with up to 14 days of follow up in the same cohort of participants. The duration of study participation for treatment period 1, 2 and 3 will be 6, 6 and up to 29 days (including follow up), respectively.
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This study's enrollment of 12 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
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Exclusion Criteria:
Eligible participants will receive a single dose (SD) of GSK3923868 500 microgram (mcg) in Treatment Period 1 followed by a single dose of placebo matching GSK3923868 in Treatment Period 2. Participants will also receive a repeat dose (RD) of GSK3923868 1500 mcg in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868.
Drug: GSK3923868 · Drug: Placebo
Eligible participants will receive a single dose of GSK3923868 500 mcg in Treatment Period 1 followed by a single dose of GSK3923868 1000 mcg in Treatment Period 2. Participants will also receive a repeat dose of placebo matching GSK3923868 in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868.
Drug: GSK3923868 · Drug: Placebo
Eligible participants will receive a single dose of GSK3923868 500 mcg in Treatment Period 1 followed by a single dose of GSK3923868 1000 mcg in Treatment Period 2. Participants will also receive repeat dose of GSK3923868 1500 mcg in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868.
Drug: GSK3923868
Eligible participants will receive a single dose of placebo matching GSK3923868 in Treatment Period 1 followed by a single dose of GSK3923868 1000 mcg in Treatment Period 2. Participants will also receive a repeat dose of GSK3923868 1500 mcg in Treatment Period 3. There will be a washout period between each treatment period. Participants will have a follow-up of 14 days after the last dose of GSK3923868.
Drug: GSK3923868 · Drug: Placebo
GSK3923868 will be administered
Placebo will be administered
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Following Single Dose of GSK3923868
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Adverse events which were not serious, were considered as non-serious adverse events.
Time frame: Up to 18 days
Number of Participants With Non-SAEs and SAEs Following Repeat Dose of GSK3923868
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Adverse events which were not serious, were considered as non-serious adverse events.
Time frame: Up to 29 days
Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Single Dose of GSK3923868
The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets and Reticulocytes, Alanine Aminotransferase, Albumin, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Sodium and Urea. Number of participants with clinically significant changes in hematology and clinical chemistry and were reported. Clinical significance was determined by the investigator.
Time frame: Up to 18 days
Number of Participants With Clinically Significant Changes in Hematology and Clinical Chemistry Laboratory Parameters Following Repeat Dose of GSK3923868
The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets and Reticulocytes, Alanine Aminotransferase, Albumin, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Sodium and Urea. Number of participants with clinically significant changes in hematology and clinical chemistry and were reported. Clinical significance was determined by the investigator.
Time frame: Up to 29 days
Number of Participants With Clinically Significant Changes in Urinalysis Parameters Following Repeat Dose of GSK3923868
Urine samples were collected at indicated time points for the analysis of urinalysis parameters including specific gravity, potential of hydrogen (pH) of urine, presence of glucose, protein, erythrocytes, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase in urine by dipstick. Number of participants with clinically significant changes in urinalysis parameters were reported. Clinical significance was determined by the investigator.
Time frame: Up to 29 days
Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Single Dose of GSK3923868
Vital signs included systolic and diastolic blood pressure, pulse rate and respiratory rate were measured with the participant in semi-supine position after at least 10 minutes rest. Tympanic Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position after at least 10 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in vital signs and ECG parameters were reported. Clinical significance was determined by the investigator.
Time frame: Up to 18 days
Number of Participants With Clinically Significant Changes in Vital Signs and 12-lead Electrocardiogram (ECG) Findings Following Repeat Dose of GSK3923868
Vital signs included systolic and diastolic blood pressure, pulse rate and respiratory rate were measured with the participant in semi-supine position after at least 10 minutes rest. Tympanic Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position after at least 10 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in vital signs and ECG parameters were reported. Clinical significance was determined by the investigator.
Time frame: Up to 29 days
Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Single Dose of GSK3923868
Spirometry included forced expiratory volume in 1 second (FEV1) for lung function assessment. FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. Spirometry assessments were performed in triplicate with the highest value reported. Number of participants with clinically significant changes in spirometry measurements were reported. Clinical significance was determined by the investigator.
Time frame: Up to 18 days
Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Repeat Dose of GSK3923868
Spirometry included forced expiratory volume in 1 second (FEV1) for lung function assessment. FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. Spirometry assessments were performed in triplicate with the highest value reported. Number of participants with clinically significant changes in spirometry measurements were reported. Clinical significance was determined by the investigator.
Time frame: Up to 29 days
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 24 Hours (AUC [0-24]) of GSK3923868 for Single Dose
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
Time frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration (AUC[0-t]) of GSK3923868 for Single Dose
Blood samples were collected at the indicated time points for PK analysis of GSK3923868. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration values were reported.
Time frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 6 Hours (AUC [0-6]) of GSK3923868 for Repeat Dose
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
Time frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3
Maximum Observed Plasma Concentration (Cmax) of GSK3923868 for Single Dose
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
Time frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
Time to Reach Cmax (Tmax) of GSK3923868 for Single Dose
Blood samples were collected at the indicated time points for analysis of tmax of GSK3923868. The tmax was obtained directly from the concentration-time data. The tmax was analyzed with the non-compartmental methods with WinNonlin.
Time frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6, 24 hours post-dose on Day 1 in Treatment Periods 1 and 2
Cmax of GSK3923868 for Repeat Dose
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
Time frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3
Tmax of GSK3923868 for Repeat Dose
Blood samples were collected at the indicated time points for analysis of tmax of GSK3923868. The tmax was obtained directly from the concentration-time data. The tmax was analyzed with the non-compartmental methods with WinNonlin.
Time frame: Pre-dose and 5, 15, 30, 45 minutes, 1, 2, 4, 6 hours post-dose on Day 1 and Day 14 in Treatment Period 3
| Milestone | GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD | Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD |
|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 |
| Completed | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD | Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD |
|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 |
| Completed | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD | Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD |
|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 |
| Completed | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD | Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD |
|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 |
| Completed | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD | Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD |
|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 |
| Completed | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Adverse events which were not serious, were considered as non-serious adverse events.
| Participants | Placebo SD | GSK3923868 500 mcg SD | GSK3923868 1000 mcg SD |
|---|---|---|---|
| Non-SAE | 1 | 2 | 1 |
| SAE | 0 | 0 | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Adverse events which were not serious, were considered as non-serious adverse events.
| Participants | Placebo RD | GSK3923868 1500 mcg RD |
|---|---|---|
| Non-SAE | 2 | 4 |
| SAE | 0 | 0 |
The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets and Reticulocytes, Alanine Aminotransferase, Albumin, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Sodium and Urea. Number of participants with clinically significant changes in hematology and clinical chemistry and were reported. Clinical significance was determined by the investigator.
| Participants | Placebo SD | GSK3923868 500 mcg SD | GSK3923868 1000 mcg SD |
|---|---|---|---|
| Hematology | 0 | 0 | 0 |
| Clinical Chemistry | 0 | 0 | 0 |
The laboratory measurements included hematology and clinical chemistry. The parameters evaluated were Basophil, Eosinophil, Erythrocyte Mean Corpuscular Hemoglobin, Erythrocyte Mean Corpuscular Volume, Erythrocytes, Hematocrit, Hemoglobin, Lymphocyte, Monocyte, Neutrophils, Platelets and Reticulocytes, Alanine Aminotransferase, Albumin, Alkaline phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Sodium and Urea. Number of participants with clinically significant changes in hematology and clinical chemistry and were reported. Clinical significance was determined by the investigator.
| Participants | Placebo RD | GSK3923868 1500 mcg RD |
|---|---|---|
| Hematology | 0 | 0 |
| Clinical Chemistry | 0 | 0 |
Urine samples were collected at indicated time points for the analysis of urinalysis parameters including specific gravity, potential of hydrogen (pH) of urine, presence of glucose, protein, erythrocytes, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase in urine by dipstick. Number of participants with clinically significant changes in urinalysis parameters were reported. Clinical significance was determined by the investigator.
| Participants | Placebo RD | GSK3923868 1500 mcg RD |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Urinalysis Parameters Following Repeat Dose of GSK3923868 | 0 | 0 |
Vital signs included systolic and diastolic blood pressure, pulse rate and respiratory rate were measured with the participant in semi-supine position after at least 10 minutes rest. Tympanic Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position after at least 10 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in vital signs and ECG parameters were reported. Clinical significance was determined by the investigator.
| Participants | Placebo SD | GSK3923868 500 mcg SD | GSK3923868 1000 mcg SD |
|---|---|---|---|
| Vital Signs | 0 | 0 | 0 |
| 12-Lead ECG | 0 | 0 | 0 |
Vital signs included systolic and diastolic blood pressure, pulse rate and respiratory rate were measured with the participant in semi-supine position after at least 10 minutes rest. Tympanic Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Twelve-lead electrocardiogram were performed in a semi-supine position after at least 10 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, QT and corrected QT intervals (QTc) intervals. Number of participants with clinically significant changes in vital signs and ECG parameters were reported. Clinical significance was determined by the investigator.
| Participants | Placebo RD | GSK3923868 1500 mcg RD |
|---|---|---|
| Vital Signs | 0 | 0 |
| 12-Lead ECG | 0 | 0 |
Spirometry included forced expiratory volume in 1 second (FEV1) for lung function assessment. FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. Spirometry assessments were performed in triplicate with the highest value reported. Number of participants with clinically significant changes in spirometry measurements were reported. Clinical significance was determined by the investigator.
| Participants | Placebo SD | GSK3923868 500 mcg SD | GSK3923868 1000 mcg SD |
|---|---|---|---|
| Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Single Dose of GSK3923868 | 0 | 0 | 0 |
Spirometry included forced expiratory volume in 1 second (FEV1) for lung function assessment. FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. Spirometry assessments were performed in triplicate with the highest value reported. Number of participants with clinically significant changes in spirometry measurements were reported. Clinical significance was determined by the investigator.
| Participants | Placebo RD | GSK3923868 1500 mcg RD |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Spirometry Measurements Following Repeat Dose of GSK3923868 | 0 | 0 |
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
| Hours* picograms per milliliter | GSK3923868 500 mcg SD | GSK3923868 1000 mcg SD |
|---|---|---|
| Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 24 Hours (AUC [0-24]) of GSK3923868 for Single Dose | 23463.81 ± 24.02 | 46553.52 ± 21.29 |
Blood samples were collected at the indicated time points for PK analysis of GSK3923868. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration values were reported.
| Hours* picograms per milliliter | GSK3923868 500 mcg SD | GSK3923868 1000 mcg SD |
|---|---|---|
| Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration (AUC[0-t]) of GSK3923868 for Single Dose | 23443.19 ± 23.96 | 46519.91 ± 21.28 |
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
| Hours* picograms per milliliter | GSK3923868 1500 mcg RD |
|---|---|
| Day 1 | 42593.74 ± 19.93 |
| Day 14 | 40787.96 ± 12.96 |
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
| Picograms per milliliter | GSK3923868 500 mcg SD | GSK3923868 1000 mcg SD |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of GSK3923868 for Single Dose | 4823.19 ± 26.72 | 10042.80 ± 11.93 |
Blood samples were collected at the indicated time points for analysis of tmax of GSK3923868. The tmax was obtained directly from the concentration-time data. The tmax was analyzed with the non-compartmental methods with WinNonlin.
| Hours | GSK3923868 500 mcg SD | GSK3923868 1000 mcg SD |
|---|---|---|
| Time to Reach Cmax (Tmax) of GSK3923868 for Single Dose | 1.00 (0.8 to 2.0) | 1.00 (0.8 to 2.0) |
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis of GSK3923868. Pharmacokinetic analysis was conducted using standard non-compartmental method with WinNonlin.
| Picograms per milliliter | GSK3923868 1500 mcg RD |
|---|---|
| Day 1 | 14081.13 ± 13.69 |
| Day 14 | 13854.60 ± 25.57 |
Blood samples were collected at the indicated time points for analysis of tmax of GSK3923868. The tmax was obtained directly from the concentration-time data. The tmax was analyzed with the non-compartmental methods with WinNonlin.
| Hours | GSK3923868 1500 mcg RD |
|---|---|
| Day 1 | 0.95 (0.8 to 2.0) |
| Day 14 | 1.00 (0.8 to 2.0) |
Collected over All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 18 days for single dose cohorts and up to 29 days for repeat dose cohorts. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo SD | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| GSK3923868 500 mcg SD | 0/9 (0%) | 0/9 (0%) | 2/9 (22.2%) |
| GSK3923868 1000 mcg SD | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| Placebo RD | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| GSK3923868 1500 mcg RD | 0/9 (0%) | 0/9 (0%) | 4/9 (44.4%) |
| Event | Placebo SD | GSK3923868 500 mcg SD | GSK3923868 1000 mcg SD | Placebo RD | GSK3923868 1500 mcg RD |
|---|---|---|---|---|---|
| Ear painEar and labyrinth disorders | 0/6 | 0/9 | 0/9 | 1/3 | 0/9 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/6 | 0/9 | 0/9 | 1/3 | 0/9 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 0/6 | 0/9 | 0/9 | 1/3 | 0/9 |
| HeadacheNervous system disorders | 0/6 | 1/9 | 0/9 | 0/3 | 2/9 |
| HaematomaVascular disorders | 0/6 | 0/9 | 0/9 | 0/3 | 2/9 |
| AstheniaGeneral disorders | 1/6 | 0/9 | 0/9 | 0/3 | 0/9 |
| Abdominal pain upperGastrointestinal disorders | 0/6 | 0/9 | 0/9 | 0/3 | 1/9 |
| Vessel puncture site haematomaGeneral disorders | 0/6 | 0/9 | 1/9 | 0/3 | 0/9 |
| DizzinessNervous system disorders | 0/6 | 1/9 | 0/9 | 0/3 | 0/9 |
| DysgeusiaNervous system disorders | 0/6 | 0/9 | 1/9 | 0/3 | 0/9 |
| Age, Continuous(YEARS) | GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD | Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD | Total |
|---|---|---|---|---|---|
| Mean | 67.7 ± 2.31 | 59.3 ± 5.69 | 63.3 ± 7.23 | 68.0 ± 1.00 | 64.6 ± 5.50 |
| Sex/Gender, Customized(Participants) | GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD | Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD | Total |
|---|---|---|---|---|---|
| De-identified | 3 | 3 | 3 | 3 | 12 |
| Race/Ethnicity, Customized(Participants) | GSK3923868 500 mcg SD/Placebo SD/GSK3923868 1500 mcg RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/Placebo RD | GSK3923868 500 mcg SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD | Placebo SD/GSK3923868 1000 mcg SD/GSK3923868 1500 mcg RD | Total |
|---|---|---|---|---|---|
| De-identified | 3 | 3 | 3 | 3 | 12 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GSK3923868
Pulmonary Disease, Chronic Obstructive →