Trial · NCT00850642
GSK2190915 Moderate to Severe Asthma Study
NCT00850642, Phase 2, Terminated, GlaxoSmithKline; results first posted 2018-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. GSK2190915 Moderate to Severe Asthma Study. Trials, record NCT00850642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00850642
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GSK2190915 Moderate to Severe Asthma Study
- NCT number
- NCT00850642
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- GSK2190195 100mg, Placebo
- First posted
- 2009-02-25
- Last updated
- 2020-11-30
- Other registries' IDs
- eudract:2008-007244-33
- Results first posted
- 2018-03-01
- Limitations and caveats
- The study was terminated early due to difficulties in recruiting the required participants.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count | Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28) | 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. |
| Primary | Percentage of Neutrophils in Induced Sputum | Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28) | 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. |
| Secondary | Assessment of FEV1 on Visit 2, 3 and Visit 4 | Visit 2 (Day 1), visit 3 (Day 5 to 7) and visit 4 (Day 12) | 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. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From visit 1 (Day -7 to Day -9) to upto follow-up (upto Day 28) | 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. |
| Secondary | Number of Participants With Vital Sign of Potential Clinical Concern (PCC) | Visit 2 (Day 1) to Upto follow-up (Day 28) | 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. |
| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Visit 2 (Day 1) to Upto follow-up (Day 28) | 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. |
| Secondary | Number of Participants With Clinical Chemistry Values of PCC | Visit 2 (Day 1) to Upto follow-up (Day 28) | 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. |
| Secondary | Number of Participants With Hematology Values of PCC | Visit 2 (Day 1) to Upto follow-up (Day 28) | 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. |
| Secondary | Plasma Concentration of GSK2190915 | At Day 1, pre-dose; Day 1, 2 hour; Day 12, pre-dose; and Day 12, 2 hour | 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. |
| Secondary | Percentage Change From Baseline Urine LTE4 Biomarker | Day 1 and Day 12 | 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). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count | Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28) | All Subject Population was defined as all participants who receive at least one dose of study medication. | Giga cells per g | MEAN |
| PRIMARY | Percentage of Neutrophils in Induced Sputum | Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28) | All Subject Population. Only those participants available at the specified time points were analyzed. | Percentage of neutrophils | MEAN |
| SECONDARY | Assessment of FEV1 on Visit 2, 3 and Visit 4 | Visit 2 (Day 1), visit 3 (Day 5 to 7) and visit 4 (Day 12) | 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. | Liters | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From visit 1 (Day -7 to Day -9) to upto follow-up (upto Day 28) | All Subject Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Sign of Potential Clinical Concern (PCC) | Visit 2 (Day 1) to Upto follow-up (Day 28) | All subject population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Visit 2 (Day 1) to Upto follow-up (Day 28) | All Subject Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Chemistry Values of PCC | Visit 2 (Day 1) to Upto follow-up (Day 28) | All subject population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hematology Values of PCC | Visit 2 (Day 1) to Upto follow-up (Day 28) | All subject population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentration of GSK2190915 | At Day 1, pre-dose; Day 1, 2 hour; Day 12, pre-dose; and Day 12, 2 hour | All Subject Population. | Nanogram per millilitre | MEAN |
| SECONDARY | Percentage Change From Baseline Urine LTE4 Biomarker | Day 1 and Day 12 | All subject population. | Percent change | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count | Placebo | Day -9 to -7 | 5.205 | Standard Deviation 2.8415 | Giga cells per g |
| The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count | GSK2190915 | Day -9 to -7 | 3.096 | Standard Deviation 2.6093 | Giga cells per g |
| The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count | Placebo | Day 1 | 3.142 | Standard Deviation 3.2449 | Giga cells per g |
| The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count | GSK2190915 | Day 1 | 14.667 | Standard Deviation 20.8291 | Giga cells per g |
| The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count | Placebo | Day 12 | 13.534 | Standard Deviation 13.6394 | Giga cells per g |
| The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count | GSK2190915 | Day 12 | 0.396 | Standard Deviation 0.0801 | Giga cells per g |
| The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count | Placebo | Follow-up | 5.359 | Standard Deviation 1.1681 | Giga cells per g |
| The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count | GSK2190915 | Follow-up | 2.995 | Standard Deviation 3.6389 | Giga cells per g |
| Percentage of Neutrophils in Induced Sputum | Placebo | Day -9 to -7 | 84.00 | Standard Deviation 9.469 | Percentage of neutrophils |
| Percentage of Neutrophils in Induced Sputum | GSK2190915 | Day -9 to -7 | 74.88 | Standard Deviation 2.269 | Percentage of neutrophils |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 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 | 3 | |
| Overall Study | STARTED | GSK2190915 | 4 | |
| Overall Study | COMPLETED | Placebo | 3 | |
| Overall Study | COMPLETED | GSK2190915 | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | GSK2190915 | 0 |
Source ClinicalTrials.gov
Adverse events22
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 | 1 | 3 | |
| other | Headache | Nervous system disorders | GSK2190915 | 2 | 4 | |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 3 | |
| other | Palpitations | Cardiac disorders | GSK2190915 | 1 | 4 | |
| other | Supraventricular extrasystoles | Cardiac disorders | Placebo | 0 | 3 | |
| other | Supraventricular extrasystoles | Cardiac disorders | GSK2190915 | 1 | 4 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 3 | |
| other | Abdominal pain | Gastrointestinal disorders | GSK2190915 | 1 | 4 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 3 | |
| other | Constipation | Gastrointestinal disorders | GSK2190915 | 1 | 4 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 3 |
| Total, all-cause mortality | GSK2190915 | 0 | 4 |
| Total, other adverse events | Placebo | 2 | 3 |
| Total, other adverse events | GSK2190915 | 3 | 4 |
| Total, serious adverse events | Placebo | 0 | 3 |
| Total, serious adverse events | GSK2190915 | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK2190915 vs Placebo: Number of Participants With Hematology Values of PCC | Trial comparisons |
| GSK2190915 vs Placebo: Number of Participants With Clinical Chemistry Values of PCC | Trial comparisons |
| GSK2190915 vs Placebo: deaths from any cause | Trial comparisons |
| GSK2190915 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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00850642
GET https://conductscience.org/api/trials/v1/NCT00850642/results?page=2