The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily in uncontrolled asthmatic subjects \> or = 18 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 to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects \> or = 18 years of age over the course of 6 weeks treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
145
FP/SAL 250/50mcg BID
GSK2190915 200mg QD (AM)
GSK2190915 100mg QD (AM)
Montelukast 10mg QD (PM)
Placebo tablets (2) (AM)
Placebo capsule (PM)
GSK Investigational Site
Pleven, Bulgaria
GSK Investigational Site
Rousse, Bulgaria
GSK Investigational Site
Varna, Bulgaria
GSK Investigational Site
Bialystok, Poland
GSK Investigational Site
Lodz, Poland
GSK Investigational Site
Tarnów, Poland
GSK Investigational Site
Dnipropetrovsk, Ukraine
GSK Investigational Site
Dnipropetrovsk, Ukraine
GSK Investigational Site
Donetsk, Ukraine
GSK Investigational Site
Ivano-Frankivsk, Ukraine
...and 9 more locations
Trough (AM pre-dose and pre-rescue bronchodilator) FEV1
Time frame: at the end of the 6 week treatment period.
• Daily trough (AM pre-dose and pre-rescue bronchodilator) AM PEF
Time frame: averaged over the last 3 weeks of the 6 week treatment period.
• Daily PM PEF
Time frame: averaged over the last 3 weeks of the 6 week treatment period.
• Daily (average of AM and PM)
Time frame: averaged over the last 3 weeks of the 6 week treatment period
• Daily asthma symptom score
Time frame: averaged over the last 3 weeks of the 6 week treatment period.
• Daily rescue salbutamol use
Time frame: averaged over the last 3 weeks of the 6 week treatment period.
• Percentage of symptom-free days
Time frame: during the last 3 weeks of the 6 week treatment period.
• Percentage of symptom-free nights
Time frame: during the last 3 weeks of the 6 week treatment period.
• Percentage of rescue-free days
Time frame: during the last 3 weeks of the 6 week treatment period.
• Percentage of rescue-free nights
Time frame: during the last 3 weeks of the 6 week treatment period.
• Percentage of nights without awakenings due to asthma
Time frame: during the last 3 weeks of the 6 week treatment period.
• Proportion of subjects withdrawn due to lack of efficacy
Time frame: during the last 3 weeks of the 6 week treatment period.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.