Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma
Overview[ - collapse ][ - ]
Purpose | 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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Condition | Asthma |
Intervention | Drug: FP/SAL 250/50mcg BID Drug: GSK2190915 200mg QD (AM) Drug: GSK2190915 100mg QD (AM) Drug: Montelukast 10mg QD (PM) Drug: Placebo tablets (2) (AM) Drug: Placebo capsule (PM) |
Phase | Phase 2 |
Sponsor | GlaxoSmithKline |
Responsible Party | GlaxoSmithKline |
ClinicalTrials.gov Identifier | NCT01248975 |
First Received | November 24, 2010 |
Last Updated | June 14, 2012 |
Last verified | April 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | November 24, 2010 |
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Last Updated Date | June 14, 2012 |
Start Date | December 2010 |
Estimated Primary Completion Date | October 2011 |
Current Primary Outcome Measures | Trough (AM pre-dose and pre-rescue bronchodilator) FEV1 [Time Frame: at the end of the 6 week treatment period.] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Safety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma |
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Official Title | 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 |
Brief 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic |
Condition | Asthma |
Intervention | 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) |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 145 |
Estimated Completion Date | October 2011 |
Estimated Primary Completion Date | October 2011 |
Eligibility Criteria | Inclusion Criteria: - Age: 18 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 - For current and former smokers, a 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/SAL 250/50mcg 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. Exclusion criteria: - 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 - Compliance: any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol - Affiliation with Investigator's Site |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Bulgaria, Poland, Ukraine |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01248975 |
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Other Study ID Numbers | 114387 |
Has Data Monitoring Committee | No |
Information Provided By | GlaxoSmithKline |
Study Sponsor | GlaxoSmithKline |
Collaborators | Not Provided |
Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
Verification Date | April 2012 |
Locations[ + expand ][ + ]
GSK Investigational Site | Pleven, Bulgaria, 5800 |
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GSK Investigational Site | Ruse, Bulgaria, 7000 |
GSK Investigational Site | Varna, Bulgaria, 9010 |
GSK Investigational Site | Bialystok, Poland, 15-084 |
GSK Investigational Site | Lodz, Poland, 93-329 |
GSK Investigational Site | Tarnow, Poland, 33-100 |
GSK Investigational Site | Dnipropetrovsk, Ukraine, 49051 |
GSK Investigational Site | Dnipropetrovsk, Ukraine, 49027 |
GSK Investigational Site | Donetsk, Ukraine, 83099 |
GSK Investigational Site | Ivano-Frankivsk, Ukraine, 76018 |
GSK Investigational Site | Kiev, Ukraine, 3680 |
GSK Investigational Site | Kiev, Ukraine, 03680 |
GSK Investigational Site | Kyiv, Ukraine, 02091 |
GSK Investigational Site | Kyiv, Ukraine, 03115 |
GSK Investigational Site | Kyiv, Ukraine, 02232 |
GSK Investigational Site | Kyiv, Ukraine, 04107 |
GSK Investigational Site | Zaporizhia, Ukraine, 69035 |