Trial Outcomes & Findings for GSK2190915 Moderate to Severe Asthma Study (NCT NCT00850642)
NCT ID: NCT00850642
Last Updated: 2020-11-30
Results Overview
The neutrophils play an important role in participants with more severe asthma. The reduction in number of neutrophils in induced sputum was evaluated to study the effect of treatment with repeat oral doses of GSK2190915, in asthma participants. Sputum samples were evaluated at central laboratory. The samples were rejected, if the weight was less than 100 grams (g), or if excessive cell degeneration or due to excessive squamous cells and insufficient inflammatory cells. The total cell count of neutrophil was reported as total cell count × 10\^6 /g.
TERMINATED
PHASE2
7 participants
Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28)
2020-11-30
Participant Flow
The study was terminated prior to completion due to difficulties in recruiting the required participants. A total of 7 asthmatic participants completed the study prior to termination. The study was, conducted from 26 June 2009 to 02 June 2010, at three centers in Canada and three centers in the United Kingdom.
Participant milestones
| Measure |
Placebo
The eligible participants in this arm were administered with matching placebo, orally, once daily for 12-days.
|
GSK2190915
The eligible participants in this arm received GSK2190915 as 100 milligram (mg), orally once daily for 12-days.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GSK2190915 Moderate to Severe Asthma Study
Baseline characteristics by cohort
| Measure |
Placebo
n=3 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days.
|
GSK2190915
n=4 Participants
The eligible participants in this arm received GSK2190915 as 100 mg, orally, once daily for 12-days.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 Years
STANDARD_DEVIATION 12.12 • n=5 Participants
|
57.8 Years
STANDARD_DEVIATION 6.65 • n=7 Participants
|
55.3 Years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28)Population: All Subject Population was defined as all participants who receive at least one dose of study medication.
The neutrophils play an important role in participants with more severe asthma. The reduction in number of neutrophils in induced sputum was evaluated to study the effect of treatment with repeat oral doses of GSK2190915, in asthma participants. Sputum samples were evaluated at central laboratory. The samples were rejected, if the weight was less than 100 grams (g), or if excessive cell degeneration or due to excessive squamous cells and insufficient inflammatory cells. The total cell count of neutrophil was reported as total cell count × 10\^6 /g.
Outcome measures
| Measure |
Placebo
n=3 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
|
GSK2190915
n=4 Participants
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
|
|---|---|---|
|
The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count
Day -9 to -7
|
5.205 Giga cells per g
Standard Deviation 2.8415
|
3.096 Giga cells per g
Standard Deviation 2.6093
|
|
The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count
Day 1
|
3.142 Giga cells per g
Standard Deviation 3.2449
|
14.667 Giga cells per g
Standard Deviation 20.8291
|
|
The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count
Day 12
|
13.534 Giga cells per g
Standard Deviation 13.6394
|
0.396 Giga cells per g
Standard Deviation 0.0801
|
|
The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count
Follow-up
|
5.359 Giga cells per g
Standard Deviation 1.1681
|
2.995 Giga cells per g
Standard Deviation 3.6389
|
PRIMARY outcome
Timeframe: Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28)Population: All Subject Population. Only those participants available at the specified time points were analyzed.
The neutrophils play an important role in participants with more severe asthma. The reduction in number of neutrophils in induced sputum was evaluated to study the effect of treatment with repeat oral doses of GSK2190915, in asthma participants. Sputum samples were evaluated at central laboratory. The samples were rejected, if the weight was less than 100 g, or if excessive cell degeneration or due to excessive squamous cells and insufficient inflammatory cells. The total cell count of neutrophil was reported as percentage of cells.
Outcome measures
| Measure |
Placebo
n=3 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
|
GSK2190915
n=4 Participants
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
|
|---|---|---|
|
Percentage of Neutrophils in Induced Sputum
Day -9 to -7
|
84.00 Percentage of neutrophils
Standard Deviation 9.469
|
74.88 Percentage of neutrophils
Standard Deviation 2.269
|
|
Percentage of Neutrophils in Induced Sputum
Day 1, pre-dose
|
68.00 Percentage of neutrophils
Standard Deviation 10.607
|
74.77 Percentage of neutrophils
Standard Deviation 18.351
|
|
Percentage of Neutrophils in Induced Sputum
Day 12, 2 hour
|
86.30 Percentage of neutrophils
Standard Deviation 16.263
|
56.33 Percentage of neutrophils
Standard Deviation 19.732
|
|
Percentage of Neutrophils in Induced Sputum
Follow-up
|
65.75 Percentage of neutrophils
Standard Deviation 0.071
|
78.33 Percentage of neutrophils
Standard Deviation 14.640
|
SECONDARY outcome
Timeframe: Visit 2 (Day 1), visit 3 (Day 5 to 7) and visit 4 (Day 12)Population: All Subject population. Individual participant data reported, due to early termination of study. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.
FEV1 is the amount of air which can be forcefully exhaled in 1 second. It was assessed using a spirometry. Due to early termination of the study, the data of individual participants is reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
|
GSK2190915
n=4 Participants
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
|
|---|---|---|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 6, Day 12, Pre-dose
|
—
|
1.10 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 6, Day 12, 2 hour
|
—
|
1.19 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 1, Day 1, Pre-dose
|
2.33 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 1, Day 1, 2 hour
|
2.55 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 1, Day 5 to 7/ Visit 3
|
2.56 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 1, Day 12, Pre-dose
|
2.83 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 1, Day 12, 2 hour
|
2.77 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 2, Day 1, Pre-dose
|
2.88 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 2, Day 1, 2 hour
|
3.06 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 2, Day 5 to 7/Visit 3
|
2.96 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 2, Day 12, Pre-dose
|
3.26 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 2, Day 12, 2 hour
|
3.14 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 3, Day 1, Pre-dose
|
1.65 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 3, Day 1, 2 hour
|
1.98 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 3, Day 5 to 7/ Visit 3
|
1.92 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 3, Day 12, Pre-dose
|
1.81 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 3, Day 12, 2 hour
|
1.83 Liters
|
—
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 4, Day 1, Pre-dose
|
—
|
1.97 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 4, Day 1, 2 hour
|
—
|
2.14 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 4, Day 5 to 7/ Visit 3
|
—
|
2.22 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 4, Day 12, Pre-dose
|
—
|
2.02 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 4, Day 12, 2 hour
|
—
|
1.90 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 5, Day 1, Pre-dose
|
—
|
2.24 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 5, Day 1, 2 hour
|
—
|
2.78 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 5, Day 5 to 7/ Visit 3
|
—
|
2.07 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 5, Day 12, Pre-dose
|
—
|
1.89 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 5, Day 12, 2 hour
|
—
|
2.02 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 6, Day 1, Pre-dose
|
—
|
1.10 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 6, Day 1, 2 hour
|
—
|
1.22 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 6, Day 5 to 7/ Visit 3
|
—
|
1.22 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 7, Day 1, Pre-dose
|
—
|
1.03 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Particpant 7, Day 1, 2 hour
|
—
|
1.13 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 7, Day 5 to 7/ Visit 3
|
—
|
1.14 Liters
|
|
Assessment of FEV1 on Visit 2, 3 and Visit 4
Participant 7, Day 12, Pre-dose
|
—
|
1.11 Liters
|
SECONDARY outcome
Timeframe: From visit 1 (Day -7 to Day -9) to upto follow-up (upto Day 28)Population: All Subject Population.
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An 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/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.
Outcome measures
| Measure |
Placebo
n=3 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
|
GSK2190915
n=4 Participants
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 1) to Upto follow-up (Day 28)Population: All subject population.
The vital sign measurement included measurement of systolic and diastolic blood pressure alongwith pulse rate. The PCC values reported for systolic blood pressure were \< 85 millimeter of mercury (mmHg) and \>160 mmHg; that for diastolic was \<45 mmHg and \>100 mmHg. The PCC values for pulse rate were \<40 and \> 110 beats per minute. The number of participants with values outside the PCC for systolic, diastolic blood pressure and vitals during the treatment duration were reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
|
GSK2190915
n=4 Participants
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
|
|---|---|---|
|
Number of Participants With Vital Sign of Potential Clinical Concern (PCC)
Systolic blood pressure
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign of Potential Clinical Concern (PCC)
Diastolic blood pressure
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign of Potential Clinical Concern (PCC)
Heart rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 1) to Upto follow-up (Day 28)Population: All Subject Population.
The number of participants with abnormal ECG values were reported. The data was reported as Abnormal clinically significant (CS), abnormal not clinically significant (NCS), and No result.
Outcome measures
| Measure |
Placebo
n=3 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
|
GSK2190915
n=4 Participants
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
|
|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal NCS, Day 1, pre-dose
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
No results, Day 1 pre-dose 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
No results, Day 1 pre-dose 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Abnormal NCS, Day 1, pre-dose 2 hour
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 1) to Upto follow-up (Day 28)Population: All subject population.
The clinical chemistry parameters evaluated were albumin, calcium, creatinine, glucose, magnesium, phosphorus, potassium, sodium, urea, gamma glutamyl transferase, and bicarbonate. The number of participants with values outside the PCC values were reported. The PCC value observed for bicarbonate was reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
|
GSK2190915
n=4 Participants
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
|
|---|---|---|
|
Number of Participants With Clinical Chemistry Values of PCC
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (Day 1) to Upto follow-up (Day 28)Population: All subject population.
The hematology parameters evaluated were white blood cells, neutrophils, hemoglobin, hematocrit, platelets and lymphocytes. The number of participants with values outside the PCC values were reported. The PCC value observed for lymphocyte was reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
|
GSK2190915
n=4 Participants
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
|
|---|---|---|
|
Number of Participants With Hematology Values of PCC
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Day 1, pre-dose; Day 1, 2 hour; Day 12, pre-dose; and Day 12, 2 hourPopulation: All Subject Population.
The blood samples for analysis of pharmacokinetic parameters were collected at pre-dose and 2 hours post dose on Day 1 and pre-dose trough and 2 hour post dose on Day 12, to evaluate the concentration of the drug GSK2190915 in plasma.
Outcome measures
| Measure |
Placebo
n=4 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
|
GSK2190915
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
|
|---|---|---|
|
Plasma Concentration of GSK2190915
Day 1, pre-dose
|
0.000 Nanogram per millilitre
Standard Deviation NA
For 0.000 dispersion could not be calculated.
|
—
|
|
Plasma Concentration of GSK2190915
Day 1, 2 hour
|
1609.303 Nanogram per millilitre
Standard Deviation 958.4609
|
—
|
|
Plasma Concentration of GSK2190915
Day 12, pre-dose
|
1073.623 Nanogram per millilitre
Standard Deviation 627.7852
|
—
|
|
Plasma Concentration of GSK2190915
Day 12, 2 hour
|
2334.238 Nanogram per millilitre
Standard Deviation 1252.5057
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 12Population: All subject population.
The urine spot samples were collected from the participants at pre-dose on day 1 and trough day 12 for evaluation of LTE4 biomarker. This evaluated the level of inflammation in the airways of the asthma participants. The percentage change from baseline was calculated by dividing the post randomization change by the baseline value from the individual and multiplying by a 100. If either the baseline or post-randomization value is missing, the change from baseline is set to missing. Baseline was defined as Day 1(pre-dose).
Outcome measures
| Measure |
Placebo
n=3 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
|
GSK2190915
n=4 Participants
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
|
|---|---|---|
|
Percentage Change From Baseline Urine LTE4 Biomarker
|
26.22 Percent change
Standard Deviation 89.173
|
-89.62 Percent change
Standard Deviation 4.996
|
SECONDARY outcome
Timeframe: Day 1 and Day 12Population: All subject population.
The plasma samples were evaluated for presence of LTB4 biomarkers. The percentage change from baseline was calculated by dividing the post-randomization change by the baseline value from the individual and multiplying by a 100. If either the baseline or post-randomization value is missing, the change from baseline is set to missing. Baseline was defined as Day 1(pre-dose).
Outcome measures
| Measure |
Placebo
n=3 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
|
GSK2190915
n=4 Participants
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
|
|---|---|---|
|
Percentage Change From Baseline of LTB4 Biomarker in Plasma
Day 1, 2 hour
|
-24.72 Percentage change
Standard Deviation 53.130
|
-95.24 Percentage change
Standard Deviation 6.711
|
|
Percentage Change From Baseline of LTB4 Biomarker in Plasma
Day 12, pre-dose
|
282.81 Percentage change
Standard Deviation 452.763
|
-95.29 Percentage change
Standard Deviation 7.326
|
|
Percentage Change From Baseline of LTB4 Biomarker in Plasma
Day 12, 2 hour
|
-22.05 Percentage change
Standard Deviation 58.391
|
-99.23 Percentage change
Standard Deviation 1.010
|
SECONDARY outcome
Timeframe: Day 1 and Day 12Population: All Subject Population. Data not collected.
The concentration of LTB4 levels in sputum were evaluated. However due to early termination of the study, the data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 and Day 12Population: All Subject Population. Data not summarized for this parameter.
The blood samples were collected to evaluate the concentration of IL-17 and hsCRP in blood. However due to early termination of the study, the data was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 and Day 12Population: All Subjects Population. Collected data were below the limit of quantification, so data could not be summarized
During the study conduct it was observed that the levels of IL-17, measured in both blood and sputum were below limit of quantification; for neutrophil elastase, in sputum no inference could be made as most levels were above the limit of quantification. Thus due to limited amount of data the analysis was not summarized.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Day 1, Day 5 to 7 and Day 12Population: All Subject Population.
ACQ measures the adequacy of asthma control. It includes 5 questions about symptoms of asthma, 1 question about the rescue medication used and 1 about lung function (FEV1% predicted). This is a 7-item scale where the items are equally weighted and the ACQ score is the mean of 7 items which ranges from 0 to 6. 0= Well controlled and 6=extremely poorly controlled. Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma. Thus for ACQ a higher score indicates severe disease and a low score indicative of less severe disease.
Outcome measures
| Measure |
Placebo
n=3 Participants
The eligible participants in this arm were administered with matching placebo, orally once daily for 12-days
|
GSK2190915
n=4 Participants
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ) Assessment
Day 1
|
1.19 Scores on scale
Standard Deviation 0.218
|
1.57 Scores on scale
Standard Deviation 0.857
|
|
Asthma Control Questionnaire (ACQ) Assessment
Day 5 to 7
|
1.29 Scores on scale
Standard Deviation 0.286
|
1.50 Scores on scale
Standard Deviation 0.474
|
|
Asthma Control Questionnaire (ACQ) Assessment
Day 12
|
1.14 Scores on scale
Standard Deviation 0.429
|
1.54 Scores on scale
Standard Deviation 0.811
|
Adverse Events
Placebo
GSK2190915
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=3 participants at risk
The eligible participants in this arm were administered with matching placebo, orally, once daily for 12-days.
|
GSK2190915
n=4 participants at risk
The eligible participants in this arm received GSK2190915 as 100 mg, orally once daily for 12-days.
|
|---|---|---|
|
Nervous system disorders
Headache
|
33.3%
1/3 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
50.0%
2/4 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
25.0%
1/4 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/3 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
25.0%
1/4 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
25.0%
1/4 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
25.0%
1/4 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
|
General disorders
Chills
|
33.3%
1/3 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
0.00%
0/4 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
25.0%
1/4 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
|
Investigations
Bacterial test positive
|
0.00%
0/3 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
25.0%
1/4 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
25.0%
1/4 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
25.0%
1/4 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
25.0%
1/4 • From visit 1 (Day -7) to upto follow-up (upto Day 28)
All subject population was used to record the AEs.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER