Trial · NCT01156792

Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age

NCT01156792, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-02-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age. Trials, record NCT01156792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01156792

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age
NCT number: NCT01156792
Status: Completed
Phases: Phase 2
Enrollment: 162 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Asthma
Interventions: FP 100, GSK2190915 100, GSK2190915 300, montelukast, placebo, FP/SAL 100/50
First posted: 2010-07-05
Last updated: 2017-04-05
Results first posted: 2017-02-03

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period	End of Week 6	FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant's last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug.
Secondary	Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	The PEF is a measure of lung function and measures how fast a person can breathe out. Trough PEF was measured every morning prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily electronic diary (eDiary). Daily trough morning PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Secondary	Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Secondary	Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups	Week 4 to Week 6	The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every morning and evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily average of morning and evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. This outcome measure explored the efficacy between GSK2190915 and montelukast due to the dosing time difference.
Secondary	Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	Daytime and night time asthma symptoms were recorded every evening at bedtime and every morning upon rising, respectively, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on scales ranging from '0' (implying no symptoms) to either 5 (for daytime symptoms) or 4 (for night time symptoms) (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. 24-hour period asthma symptom scores were averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Secondary	Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	A SABA (albuterol) was provided to participants as a rescue medication, to use as needed for symptomatic relief of asthma symptoms. Participants were required to record their albuterol use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The daily rescue SABA use was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Secondary	Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	Daytime asthma symptoms were recorded every evening at bedtime, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 6-point scale ranging from '0' (implying no symptoms) to 5 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of days when symptoms were not experienced ("symptom-free days") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Secondary	Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period	Week 4 to Week 6	Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale ranging from '0' (implying no symptoms) to 4 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of nights when symptoms were not experienced ("symptom-free nights") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Secondary	Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of days when rescue medication was not used ("rescue-free days") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Secondary	Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of nights when rescue medication was not used ("rescue-free nights") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period	End of Week 6	ITT Population. Only those participants available at the specified time point were analyzed.	Liters (L)	LEAST_SQUARES_MEAN
SECONDARY	Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	ITT Population. Only those participants available at the specified time point were analyzed.	Liters/minute (L/min)	LEAST_SQUARES_MEAN
SECONDARY	Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	ITT Population. Only those participants available at the specified time point were analyzed.	L/min	LEAST_SQUARES_MEAN
SECONDARY	Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups	Week 4 to Week 6	ITT Population. Only those participants available at the specified time point were analyzed.	L/min	LEAST_SQUARES_MEAN
SECONDARY	Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	ITT Population. Only those participants available at the specified time point were analyzed.	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	ITT Population. Only those participants available at the specified time point were analyzed.	Number of inhalations	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	ITT Population. Only those participants available at the specified time point were analyzed.	Percentage of days	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period	Week 4 to Week 6	ITT Population. Only those participants available at the specified time point were analyzed.	Percentage of nights	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	ITT Population. Only those participants available at the specified time point were analyzed.	Percentage of days	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period	Week 4 to Week 6	ITT Population. Only those participants available at the specified time point were analyzed.	Percentage of nights	LEAST_SQUARES_MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group58

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period	FP + Placebo	2.36	Standard Error 0.03	Liters (L)
Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period	FP + GSK2190915 100 mg	2.39	Standard Error 0.03	Liters (L)
Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period	FP + GSK2190915 300 mg	2.40	Standard Error 0.03	Liters (L)
Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period	FP + Montelukast	2.42	Standard Error 0.03	Liters (L)
Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period	FP / Salmeterol	2.43	Standard Error 0.03	Liters (L)
Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period	FP + Placebo	349.19	Standard Error 4.08	Liters/minute (L/min)
Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period	FP + GSK2190915 100 mg	350.14	Standard Error 4.06	Liters/minute (L/min)
Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period	FP + GSK2190915 300 mg	354.96	Standard Error 4.07	Liters/minute (L/min)
Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period	FP + Montelukast	354.17	Standard Error 4.05	Liters/minute (L/min)
Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period	FP / Salmeterol	361.33	Standard Error 4.05	Liters/minute (L/min)

1 to 10 of 58Source ClinicalTrials.gov

See all 58 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	All Treatments Combined	162
Overall Study	COMPLETED	All Treatments Combined	93
Overall Study	NOT COMPLETED	All Treatments Combined	69

Source ClinicalTrials.gov

Adverse events15

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
other	Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	FP + Placebo	6	104
other	Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	FP + GSK2190915 100 mg	1	103
other	Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	FP + GSK2190915 300 mg	1	96
other	Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	FP + Montelukast	1	99
other	Nasopharyngitis	Respiratory, thoracic and mediastinal disorders	FP / Salmeterol	1	104
other	Sinusitis	Respiratory, thoracic and mediastinal disorders	FP + Placebo	2	104
other	Sinusitis	Respiratory, thoracic and mediastinal disorders	FP + GSK2190915 100 mg	2	103
other	Sinusitis	Respiratory, thoracic and mediastinal disorders	FP + GSK2190915 300 mg	3	96
other	Sinusitis	Respiratory, thoracic and mediastinal disorders	FP + Montelukast	0	99
other	Sinusitis	Respiratory, thoracic and mediastinal disorders	FP / Salmeterol	0	104

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	FP + Placebo
Total, all-cause mortality	FP + GSK2190915 100 mg
Total, all-cause mortality	FP + GSK2190915 300 mg
Total, all-cause mortality	FP + Montelukast
Total, all-cause mortality	FP / Salmeterol
Total, other adverse events	FP + Placebo	8	104
Total, other adverse events	FP + GSK2190915 100 mg	3	103
Total, other adverse events	FP + GSK2190915 300 mg	4	96
Total, other adverse events	FP + Montelukast	1	99
Total, other adverse events	FP / Salmeterol	1	104

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24010736	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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