Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Treatment, Four 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 100mg, GSK2190915 300mg, Montelukast 10mg or Placebo Tablets Once Daily or Salmeterol 50mcg Inhalation Powder Twice Daily to Fluticasone Propionate 100mcg Inhalation Powder Twice Daily in Uncontrolled Asthmatic Subjects ≥ 12 Years of Age
1 other identifier
interventional
162
1 country
32
Brief Summary
The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment. The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Sep 2010
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2010
CompletedFirst Posted
Study publicly available on registry
July 5, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
February 3, 2017
CompletedApril 5, 2017
March 1, 2017
1.1 years
July 1, 2010
December 8, 2016
March 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period
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.
End of Week 6
Secondary Outcomes (11)
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
Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period
Week 4 to Week 6
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
Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period
Week 4 to Week 6
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
- +6 more secondary outcomes
Study Arms (5)
FP 100mcg BID plus GSK2190915 100mg QD (AM)
EXPERIMENTALFP 100mcg BID plus GSK2190915 100mg QD (AM)
FP 100mcg BID plus GSK2190915 300mg QD (AM)
EXPERIMENTALFP 100mcg BID plus GSK2190915 300mg QD (AM)
FP 100mcg BID plus montelukast 10mg QD (PM)
ACTIVE COMPARATORFP 100mcg BID plus montelukast 10mg QD (PM)
FP 100mcg BID plus placebo BID
ACTIVE COMPARATORFP 100mcg BID plus placebo BID
FP/SAL 100/50mcg BID plus placebo BID
ACTIVE COMPARATORFP/SAL 100/50mcg BID plus placebo BID
Interventions
FP 100mcg BID
Eligibility Criteria
You may qualify if:
- Age: 12 years of age or older
- Non-, former or current smokers with a documented smoking history of ≤ 10 pack years
- Asthma diagnosis as defined by the National Institutes of Health
- Best FEV1 of 50% to \<80% of the predicted normal value
- Post-albuterol FEV1/FVC ratio of \>0.70 at Visit 1/1a (between 5:00AM and 12:00 noon)
- ≥ 12% and ≥200mL reversibility of FEV1
- Must have been using FP 100mcg inhalation powder BID for at least 2 weeks just prior to Visit 1.
- Must be able to replace their current short-acting beta2-agonists with albuterol inhalation aerosol
- Must be able and willing to give written informed consent to take part in the study.
- Must be able and willing to comply with all aspects of the study including completion of daily e-Diary.
You may not qualify if:
- History of life-threatening asthma
- Recent asthma exacerbation
- Concurrent respiratory disease
- Recent respiratory infection
- Liver disease
- Other concurrent diseases/abnormalities
- Oral candidiasis
- Drug allergy
- Milk protein allergy
- Immunosuppressive Medications
- Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1
- OATP1B1 substrates within 4 weeks of Visit 1
- Cytochrome P450 3A4 (CYP 3A4) Inhibitors
- Cytochrome P450 3A4 (CYP 3A4) Inducers
- Investigational Medications
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (32)
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Vista, California, 92083, United States
GSK Investigational Site
Coral Gables, Florida, 33134, United States
GSK Investigational Site
Miami, Florida, 33173, United States
GSK Investigational Site
Indianapolis, Indiana, 46208, United States
GSK Investigational Site
Lenexa, Kansas, 66215, United States
GSK Investigational Site
Owensboro, Kentucky, 42301, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Bangor, Maine, 04401, United States
GSK Investigational Site
Ypsilanti, Michigan, 48197, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Bellevue, Nebraska, 68123-4303, United States
GSK Investigational Site
Ocean City, New Jersey, 07712, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Bethlehem, Pennsylvania, 18020, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Austin, Texas, 78750, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Houston, Texas, 77054, United States
GSK Investigational Site
Plano, Texas, 75024, United States
GSK Investigational Site
Waco, Texas, 76712, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
Related Publications (1)
Snowise NG, Clements D, Ho SY, Follows RM. Addition of a 5-lipoxygenase-activating protein inhibitor to an inhaled corticosteroid (ICS) or an ICS/long-acting beta-2-agonist combination in subjects with asthma. Curr Med Res Opin. 2013 Dec;29(12):1663-74. doi: 10.1185/03007995.2013.842163. Epub 2013 Sep 19.
PMID: 24010736DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2010
First Posted
July 5, 2010
Study Start
September 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
April 5, 2017
Results First Posted
February 3, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.