A Phase 2 interventional study of FP/SAL 250/50mcg BID and GSK2190915 200mg QD (AM) in Asthma, sponsored by GlaxoSmithKline. Completed at 19 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-25.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Diagnostic
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 145 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
Drug: FP/SAL 250/50mcg BID · Drug: GSK2190915 200mg QD (AM) · Drug: GSK2190915 100mg QD (AM) · Drug: Placebo capsule (PM)
FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
Drug: FP/SAL 250/50mcg BID · Drug: Montelukast 10mg QD (PM) · Drug: Placebo tablets (2) (AM)
P/SAL 250/50mcg BID plus placebo BID
Drug: FP/SAL 250/50mcg BID · Drug: Placebo tablets (2) (AM) · Drug: Placebo capsule (PM)
FP/SAL 250/50mcg BID
GSK2190915 200mg QD (AM)
GSK2190915 100mg QD (AM)
Montelukast 10mg QD (PM)
Placebo tablets (2) (AM)
Placebo capsule (PM)
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.
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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