Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily

• ClinicalTrials.gov Identifier: NCT01147744
• Recruitment Status: Completed
• First Posted: June 22, 2010
• Results First Posted: September 6, 2017
• Last Update Posted: October 2, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of age and older) with persistent asthma. These data will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried forward in Phase III asthma studies. The study also includes Fluticasone Propionate Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid and a leukotriene receptor antagonist.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Fluticasone Propionate 100mcg via ACCUHALER/DISKUS; Drug: GSK2190915 100mg; Drug: GSK2190915 10mg; Drug: GSK2190915 300mg; Drug: GSK2190915 30mg; Drug: Montelukast 10mg; Drug: Placebo GSK2190915 one tablet; Drug: Placebo montelukast; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS; Drug: Placebo GSK2190915 two tablets	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 700 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomised Double-Blind, Double-Dummy, Placebo-Controlled, Stratified, Parallel-Group, Multicentre, Dose Ranging Study to Evaluate the Efficacy and Safety of GSK2190915 Tablets Administered Once Daily, Fluticasone Propionate Inhalation Powder 100mcg Twice Daily and Montelukast 10mg Once Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma While Treated With Short Acting Beta2-agonist.
• Actual Study Start Date: June 28, 2010
• Actual Primary Completion Date: October 6, 2011
• Actual Study Completion Date: October 6, 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: GSK2190915 10mg and placebo; GSK2190915 10mg (1 x 10mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS	Drug: GSK2190915 10mg; GSK2190915 10mg (1 x 10mg) once daily in the morning; Drug: Placebo GSK2190915 one tablet; Placebo tablet, one tablet once daily in the morning; Drug: Placebo montelukast; Placebo capsule once daily in the evening; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS; Inhaled placebo twice daily via ACCUHALER/DISKUS
Experimental: GSK2190915 30mg and placebo; GSK2190915 30mg (1 x 30mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS	Drug: GSK2190915 30mg; GSK2190915 30mg (1 x 30mg) once daily in the morning; Drug: Placebo GSK2190915 one tablet; Placebo tablet, one tablet once daily in the morning; Drug: Placebo montelukast; Placebo capsule once daily in the evening; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS; Inhaled placebo twice daily via ACCUHALER/DISKUS
Experimental: GSK2190915 100mg QD and placebo; GSK2190915 100mg (1 x 100mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS	Drug: GSK2190915 100mg; GSK2190915 100mg (1 x 100mg) once daily in the morning; Drug: Placebo GSK2190915 one tablet; Placebo tablet, one tablet once daily in the morning; Drug: Placebo montelukast; Placebo capsule once daily in the evening; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS; Inhaled placebo twice daily via ACCUHALER/DISKUS
Experimental: GSK2190915 300mg QD and placebo; GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS	Drug: GSK2190915 300mg; GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning; Drug: Placebo montelukast; Placebo capsule once daily in the evening; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS; Inhaled placebo twice daily via ACCUHALER/DISKUS
Active Comparator: Fluticasone propionate 100mcg and placebo; Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS and two placebo tablets in the morning and one placebo capsule in the evening	Drug: Fluticasone Propionate 100mcg via ACCUHALER/DISKUS; Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS; Drug: Placebo montelukast; Placebo capsule once daily in the evening; Drug: Placebo GSK2190915 two tablets; Placebo tablet, two tablets once daily in the morning
Active Comparator: Montelukast 10mg and placebo; Montelukast 10mg (1 x 10mg capsule) once daily in the evening and two placebo tablets in the morning and inhaled placebo twice daily via ACCUHALER/DISKUS	Drug: Montelukast 10mg; Montelukast 10mg (1 x 10mg capsule) once daily in the evening; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS; Inhaled placebo twice daily via ACCUHALER/DISKUS; Drug: Placebo GSK2190915 two tablets; Placebo tablet, two tablets once daily in the morning
Placebo Comparator: Placebo Comparator; Two GSK2190915 placebo tablets once daily in the morning, montelukast placebo capsule once daily in the evening and fluticasone propionate placebo twice daily via ACCUHALER/DISKUS	Drug: Placebo montelukast; Placebo capsule once daily in the evening; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS; Inhaled placebo twice daily via ACCUHALER/DISKUS; Drug: Placebo GSK2190915 two tablets; Placebo tablet, two tablets once daily in the morning

Outcome Measures

Primary Outcome Measures :

1. Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 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 Outcome Measures :

1. Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period [ Time Frame: 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)
2. Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period [ Time Frame: 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).
3. Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period [ Time Frame: 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.
4. Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period [ Time Frame: 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).
5. Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period [ Time Frame: 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).
6. Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period [ Time Frame: 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).
7. Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period [ Time Frame: 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).
8. Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period [ Time Frame: 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).
9. Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period [ Time Frame: 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).
10. Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period [ Time Frame: Baseline up to Week 8 ]
    The numbers 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 night-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of night-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).
11. Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period [ Time Frame: Upto 8 Weeks ]
    The participants who met any of the following withdrawal criteria were considered to be withdrawn due to lack of efficacy: 1) Clinic FEV1 below stability limit calculated at Visit 3. 2) More than three days between two consecutive visits, PEF has fallen below stability limit calculated at Visit 3. 3) Use of 12 or more inhalations of SABA per day for more than two days between consecutive visits. 4) Asthma exacerbation defined as worsening requiring any treatment other than study medication or rescue medication. This included requiring the use of systemic or inhaled corticosteroids and /or emergency room visit or hospitalization for the treatment of asthma. The stability limit was calculated as best pre-salbutamol/albuterol FEV1 at Visit 3 x 80 percent (%).

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Type of Subject: Outpatient
• Age: ≥12 years of age
• Gender: Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
• Asthma Diagnosis: As defined by NIH
• Severity of Disease: FEV1 50-85% predicted AND in current and former smokers a post salbutamol/albuterol ratio >0.70
• Reversibility: ≥12% and ≥200mL in FEV1 within 30 ±15 minutes following salbutamol/albuterol
• Current anti-asthma therapy: Using short-acting beta-agonist (SABA) for ≥3 months
• Tobacco use: Non-smoker /former smoker with ≤10 pack years or current smoker with ≤10 pack years
• QTC: QTc(F)<450msec or QTc(F)<480 for subjects with Bundle Branch Block
• Liver function: Normal liver function
• Informed Consent

Exclusion Criteria:

• History of Life-threatening asthma: Within previous 5 years
• Asthma Exacerbation: Requiring OCS within 3 months or hospitalisation within 6 months
• Respiratory Infection: Not resolved within the 4 weeks before V1 AND led to a change in asthma management OR treatment with antibiotics OR is expected to affect the subject's asthma status or ability to participate
• Corticosteroid Use: ICS used within 6 weeks or OCS/depot corticosteroids within 12 weeks
• OATP1B1 substrates: OATP1B1 substrates (e.g. statins, rifampicin, bromosulphophthalein, benzylpenicillin, methotrexate) within 4 weeks
• Immunosuppressive medications: Either using or required during the study
• Liver disease: Current or chronic history
• Concurrent disease/abnormalities: Clinically significant uncontrolled disease
• Investigational medications: Participation in a study or used investigational drug within 30 days
• Drug allergy: β-agonists, corticosteroids, constituents of inhalers
• Milk Protein Allergy: History of severe milk protein allergy
• Compliance: Factors likely to impair compliance either with regards to study medication, procedures or attendance
• Unable or unwilling to follow instructions: Procedures, dosing directions, e-diaries or pMDIs
• History of alcohol or drug abuse: Likely to interfere with the study
• Affiliation with Investigator's Site: Relative or employee

Contacts and Locations

Locations

United States, Alabama

GSK Investigational Site

Birmingham, Alabama, United States, 35209

United States, California

GSK Investigational Site

Huntington Beach, California, United States, 92647

GSK Investigational Site

Newport Beach, California, United States, 92663

GSK Investigational Site

San Diego, California, United States, 92123

United States, Florida

GSK Investigational Site

Tallahassee, Florida, United States, 32308

United States, Kentucky

GSK Investigational Site

Owensboro, Kentucky, United States, 42301

United States, Louisiana

GSK Investigational Site

Metairie, Louisiana, United States, 70006

United States, Maine

GSK Investigational Site

Bangor, Maine, United States, 04401

United States, Michigan

GSK Investigational Site

Ypsilanti, Michigan, United States, 48197

United States, Minnesota

GSK Investigational Site

Minneapolis, Minnesota, United States, 55402

United States, Missouri

GSK Investigational Site

Columbia, Missouri, United States, 65203

GSK Investigational Site

Rolla, Missouri, United States, 65401

GSK Investigational Site

Saint Louis, Missouri, United States, 63141

United States, New Jersey

GSK Investigational Site

Ocean City, New Jersey, United States, 07712

United States, North Carolina

GSK Investigational Site

Raleigh, North Carolina, United States, 27607

United States, Ohio

GSK Investigational Site

Canton, Ohio, United States, 44718

United States, Oklahoma

GSK Investigational Site

Oklahoma City, Oklahoma, United States, 73103

United States, Oregon

GSK Investigational Site

Medford, Oregon, United States, 97504

United States, South Carolina

GSK Investigational Site

Orangeburg, South Carolina, United States, 29118

United States, Texas

GSK Investigational Site

San Antonio, Texas, United States, 78229

GSK Investigational Site

Waco, Texas, United States, 76712

United States, Washington

GSK Investigational Site

Bellingham, Washington, United States, 98225

Bulgaria

GSK Investigational Site

Pleven, Bulgaria, 5800

GSK Investigational Site

Plovdiv, Bulgaria, 4003

GSK Investigational Site

Ruse, Bulgaria, 7000

GSK Investigational Site

Sofia, Bulgaria, 1000

GSK Investigational Site

Sofia, Bulgaria, 1202

GSK Investigational Site

Sofia, Bulgaria, 1407

GSK Investigational Site

Sofia, Bulgaria, 1431

GSK Investigational Site

Stara Zagora, Bulgaria, 6000

GSK Investigational Site

Varna, Bulgaria, 9010

Japan

GSK Investigational Site

Chiba, Japan, 292-0805

GSK Investigational Site

Fukuoka, Japan, 819-0006

GSK Investigational Site

Fukuoka, Japan, 819-1102

GSK Investigational Site

Hokkaido, Japan, 062-0034

GSK Investigational Site

Hokkaido, Japan, 064-0801

GSK Investigational Site

Ibaraki, Japan, 319-1113

GSK Investigational Site

Kanagawa, Japan, 210-0852

GSK Investigational Site

Osaka, Japan, 530-0001

GSK Investigational Site

Osaka, Japan, 565-0853

GSK Investigational Site

Saitama, Japan, 343-0851

GSK Investigational Site

Tokyo, Japan, 102-0083

GSK Investigational Site

Tokyo, Japan, 103-0027

GSK Investigational Site

Tokyo, Japan, 103-0028

GSK Investigational Site

Tokyo, Japan, 130-8587

GSK Investigational Site

Tokyo, Japan, 153-0051

GSK Investigational Site

Tokyo, Japan, 154-0024

GSK Investigational Site

Tokyo, Japan, 158-0097

GSK Investigational Site

Tokyo, Japan, 171-0014

GSK Investigational Site

Tokyo, Japan, 190-0013

Poland

GSK Investigational Site

Bialystok, Poland, 15-084

GSK Investigational Site

Katowice, Poland, 40-018

GSK Investigational Site

Krakow, Poland, 31-024

GSK Investigational Site

Libiaz, Poland, 32-590

GSK Investigational Site

Lodz, Poland, 93-329

GSK Investigational Site

Poznan, Poland, 60-693

GSK Investigational Site

Tarnow, Poland, 33-100

Romania

GSK Investigational Site

Brasov, Romania, 500112

GSK Investigational Site

Bucharest, Romania, 020125

GSK Investigational Site

Bucharest, Romania, 022102

GSK Investigational Site

Bucharest, Romania, 050159

GSK Investigational Site

Cluj-Napoca, Romania, 400217

GSK Investigational Site

Cluj-Napoca, Romania, 400371

GSK Investigational Site

Deva, Romania, 330084

GSK Investigational Site

Timisoara, Romania, 300310

Ukraine

GSK Investigational Site

Dnipropetrovsk, Ukraine, 49006

GSK Investigational Site

Dnipropetrovsk, Ukraine, 49027

GSK Investigational Site

Dnipropetrovsk, Ukraine, 49051

GSK Investigational Site

Donetsk, Ukraine, 83099

GSK Investigational Site

Ivano-Frankivsk, Ukraine, 76018

GSK Investigational Site

Kharkiv, Ukraine, 61002

GSK Investigational Site

Kharkiv, Ukraine, 61037

GSK Investigational Site

Kharkiv, Ukraine, 61124

GSK Investigational Site

Kiev, Ukraine, 03680

GSK Investigational Site

Kyiv, Ukraine, 02232

GSK Investigational Site

Kyiv, Ukraine, 03115

GSK Investigational Site

Kyiv, Ukraine, 03680

GSK Investigational Site

Kyiv, Ukraine, 04107

GSK Investigational Site

Kyiv, Ukraine, 04201

GSK Investigational Site

Kyiv, Ukraine

GSK Investigational Site

Odesa, Ukraine, 65114

GSK Investigational Site

Simferopol, Ukraine, 95043

GSK Investigational Site

Yalta, Ukraine, 98603

GSK Investigational Site

Zaporizhia, Ukraine, 69035

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Annotated Case Report Form 

Identifier: 112186
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 112186
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 112186
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 112186
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 112186
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 112186
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 112186
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Follows RM, Snowise NG, Ho SY, Ambery CL, Smart K, McQuade BA. Efficacy, safety and tolerability of GSK2190915, a 5-lipoxygenase activating protein inhibitor, in adults and adolescents with persistent asthma: a randomised dose-ranging study. Respir Res. 2013 May 17;14:54. doi: 10.1186/1465-9921-14-54.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01147744
• Other Study ID Numbers: 112186
• First Posted: June 22, 2010
• Results First Posted: September 6, 2017
• Last Update Posted: October 2, 2017
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

Efficacy; Asthma; Safety; Fluticasone Propionate; FLAP; Beta-agonists; GSK2190915; Montelukast; Placebo; FLAIR

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; Xhance; Montelukast; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Anti-Allergic Agents; Leukotriene Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action