FP/SAL 250/50mcg BID
DrugFP/SAL 250/50mcg BID
NCT Number: NCT01248975
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.
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Notify Me18 year and older
Female
Interventional
Phase 2
GSK Investigational Site, Pleven, Bulgaria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FP/SAL 250/50mcg BID
GSK2190915 200mg QD (AM)
GSK2190915 100mg QD (AM)
Montelukast 10mg QD (PM)
Placebo tablets (2) (AM)
Placebo capsule (PM)
Time frame: at the end of the 6 week treatment period.
Time frame: averaged over the last 3 weeks of the 6 week treatment period.
Time frame: averaged over the last 3 weeks of the 6 week treatment period.
Time frame: averaged over the last 3 weeks of the 6 week treatment period
Time frame: averaged over the last 3 weeks of the 6 week treatment period.
Time frame: averaged over the last 3 weeks of the 6 week treatment period.
Time frame: during the last 3 weeks of the 6 week treatment period.
Time frame: during the last 3 weeks of the 6 week treatment period.
Time frame: during the last 3 weeks of the 6 week treatment period.
Time frame: during the last 3 weeks of the 6 week treatment period.
Time frame: during the last 3 weeks of the 6 week treatment period.
Time frame: during the last 3 weeks of the 6 week treatment period.
GlaxoSmithKline
Industry
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Treatment, Three 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 300mg as Compared to Adding Montelukast 10mg or Placebo Tablets QD to Fluticasone Propionate/Salmeterol 250/50mcg Diskus BID
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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