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Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma

NCT01248975 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2016-11-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

FP/SAL 250/50mcg BID

FP/SAL 250/50mcg BID

DRUG

GSK2190915 200mg QD (AM)

GSK2190915 200mg QD (AM)

DRUG

GSK2190915 100mg QD (AM)

GSK2190915 100mg QD (AM)

DRUG

Montelukast 10mg QD (PM)

Montelukast 10mg QD (PM)

DRUG

Placebo tablets (2) (AM)

Placebo tablets (2) (AM)

DRUG

Placebo capsule (PM)

Placebo capsule (PM)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Bulgaria
  • Poland
  • Ukraine

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01248975 on ClinicalTrials.gov