Trial · NCT01147744
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
NCT01147744, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-09-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily. Trials, record NCT01147744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01147744
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
- NCT number
- NCT01147744
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 700 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
Fluticasone Propionate 100mcg via ACCUHALER/DISKUS, GSK2190915 100mg, GSK2190915 10mg, GSK2190915 300mg, GSK2190915 30mg, Montelukast 10mg, Placebo GSK2190915 one tablet, Placebo montelukast, Placebo fluticasone propionate via ACCUHALER/DISKUS, Placebo GSK2190915 two tablets
- First posted
- 2010-06-22
- Last updated
- 2017-10-02
- Results first posted
- 2017-09-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | Baseline and Week 8 | Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value. Analysis of covariance (ANCOVA) model used for statistical analysis. ITT Population was comprised of all participant randomized to treatment who received at least one dose of double-blind study medication. |
| Secondary | Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | Peak expiratory flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) evening over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants) |
| Secondary | Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | The PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough AM PEF is defined as the AM pre-dose and pre-rescue bronchodilator at the clinic visit. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) AM over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). |
| Secondary | Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | Asthma symptoms were recorded in a daily electronic diary (eDiary) by the participants every day in the evening at bedtime and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant's responses to evening assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free days during the 8-Week treatment period minus the Baseline value. Baseline was defined as the last 7 days prior to randomization of the participants. |
| Secondary | Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning upon rising and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant's responses to the morning assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). |
| Secondary | Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free days during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). |
| Secondary | Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). |
| Secondary | Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period | Baseline up to Week 8 | Participants recorded their day-time asthma symptom score in an eDiary each PM at bedtime and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Day-time asthma symptom scores, as: 0=no asthma symptoms, 1=one episode of short-time asthma symptoms, 2=two or more episodes of short-time asthma symptoms, 3=asthma symptoms occurring during most part of daytime without interference with daily life activities, 4=asthma symptoms occurring during most part of daytime with interference with daily life activities, 5=severe asthma symptoms that disable working or perform normal daily activities. Change from Baseline was calculated as the averaged of day-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). |
| Secondary | Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period | Baseline up to Week 8 | Participants recorded their night-time asthma symptom score in an eDiary each AM upon rising and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Night-time asthma symptom scores, as: 0=no asthma symptoms, 1= one awakening or waking early due to asthma symptoms, 2= two or more awakenings due to asthma symptoms (including waking early), 3= asthma symptoms almost prevented the participant from sleeping, 4= severe asthma symptoms completely prevented from sleeping. Change from Baseline was calculated as the averaged of night-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). |
| Secondary | Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period | Baseline up to Week | The number of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at day-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of day-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | Baseline and Week 8 | ITT population. When possible, data from participants who withdrew prematurely from the study were included in the analyses. Any evaluable subject whose FEV1 measurement at Week 8 was missing was included in the analysis by imputation, using the preceding non-missing FEV1 value (last observation carried forward \[LOCF\]). | Liters | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Only those participants with analyzable data at the indicated time point were assessed. | Liters per minute | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Only those participants with analyzable data at the indicated time point were assessed. | Liters per minute | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Percentage of symptom-free days | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Percentage of symptom-free nights | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Percentage of rescue-free days | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Percentage of rescue-free nights | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Day-time symptom scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period | Baseline up to Week 8 | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Night-time symptom scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period | Baseline up to Week | ITT Population. Endpoint obtained from the daily diary record used all available data over the period of interest. No imputations were performed on missing data from the daily diary record. | Day-time number of inhalations | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | Placebo | 0.12 | Standard Error 0.04 | Liters | |
| Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | GSK2190915 10 mg | 0.18 | Standard Error 0.04 | Liters | |
| Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | GSK2190915 30 mg | 0.23 | Standard Error 0.04 | Liters | |
| Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | GSK2190915 100 mg | 0.19 | Standard Error 0.04 | Liters | |
| Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | GSK2190915 300 mg | 0.19 | Standard Error 0.04 | Liters | |
| Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | Fluticasone Propionate 100 mcg | 0.31 | Standard Error 0.04 | Liters | |
| Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) | Montelukast 10 mg | 0.19 | Standard Error 0.04 | Liters | |
| Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | Placebo | 8.01 | Standard Error 3.19 | Liters per minute | |
| Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | GSK2190915 10 mg | 7.62 | Standard Error 3.19 | Liters per minute | |
| Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period | GSK2190915 30 mg | 9.37 | Standard Error 3.20 | Liters per minute |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 100 | |
| Overall Study | STARTED | GSK2190915 10 Milligrams (mg) | 99 | |
| Overall Study | STARTED | GSK2190915 30mg | 100 | |
| Overall Study | STARTED | GSK2190915 100mg | 100 | |
| Overall Study | STARTED | GSK2190915 300mg | 101 | |
| Overall Study | STARTED | Fluticasone Propionate 100 Microgram (mcg) | 103 | |
| Overall Study | STARTED | Montelukast 10mg | 97 | |
| Overall Study | COMPLETED | Placebo | 71 | |
| Overall Study | COMPLETED | GSK2190915 10 Milligrams (mg) | 76 | |
| Overall Study | COMPLETED | GSK2190915 30mg | 82 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events42
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 | 3 | 100 | |
| other | Headache | Nervous system disorders | GSK2190915 10mg | 7 | 99 | |
| other | Headache | Nervous system disorders | GSK2190915 30mg | 2 | 100 | |
| other | Headache | Nervous system disorders | GSK2190915 100mg | 4 | 100 | |
| other | Headache | Nervous system disorders | GSK2190915 300mg | 4 | 101 | |
| other | Headache | Nervous system disorders | Fluticasone Propionate 100 mcg | 9 | 103 | |
| other | Headache | Nervous system disorders | Montelukast 10mg | 9 | 97 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 5 | 100 | |
| other | Nasopharyngitis | Infections and infestations | GSK2190915 10mg | 6 | 99 | |
| other | Nasopharyngitis | Infections and infestations | GSK2190915 30mg | 3 | 100 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 100 |
| Total, all-cause mortality | GSK2190915 10mg | 0 | 99 |
| Total, all-cause mortality | GSK2190915 30mg | 0 | 100 |
| Total, all-cause mortality | GSK2190915 100mg | 0 | 100 |
| Total, all-cause mortality | GSK2190915 300mg | 0 | 101 |
| Total, all-cause mortality | Fluticasone Propionate 100 mcg | 0 | 103 |
| Total, all-cause mortality | Montelukast 10mg | 0 | 97 |
| Total, other adverse events | Placebo | 10 | 100 |
| Total, other adverse events | GSK2190915 10mg | 13 | 99 |
| Total, other adverse events | GSK2190915 30mg | 6 | 100 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23682661 | DERIVED |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01147744
GET https://conductscience.org/api/trials/v1/NCT01147744/results?page=2