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.
ConditionAsthma
InterventionDrug: 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)
PhasePhase 2
SponsorGlaxoSmithKline
Responsible PartyGlaxoSmithKline
ClinicalTrials.gov IdentifierNCT01248975
First ReceivedNovember 24, 2010
Last UpdatedJune 14, 2012
Last verifiedApril 2012

Tracking Information[ + expand ][ + ]

First Received DateNovember 24, 2010
Last Updated DateJune 14, 2012
Start DateDecember 2010
Estimated Primary Completion DateOctober 2011
Current Primary Outcome MeasuresTrough (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
  • • 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.] [Designated as safety issue: No]
  • • Daily PM PEF [Time Frame: averaged over the last 3 weeks of the 6 week treatment period.] [Designated as safety issue: No]
  • • Daily (average of AM and PM) [Time Frame: averaged over the last 3 weeks of the 6 week treatment period] [Designated as safety issue: No]
  • • Daily asthma symptom score [Time Frame: averaged over the last 3 weeks of the 6 week treatment period.] [Designated as safety issue: No]
  • • Daily rescue salbutamol use [Time Frame: averaged over the last 3 weeks of the 6 week treatment period.] [Designated as safety issue: No]
  • • Percentage of symptom-free days [Time Frame: during the last 3 weeks of the 6 week treatment period.] [Designated as safety issue: No]
  • • Percentage of symptom-free nights [Time Frame: during the last 3 weeks of the 6 week treatment period.] [Designated as safety issue: No]
  • • Percentage of rescue-free days [Time Frame: during the last 3 weeks of the 6 week treatment period.] [Designated as safety issue: No]
  • • Percentage of rescue-free nights [Time Frame: during the last 3 weeks of the 6 week treatment period.] [Designated as safety issue: No]
  • • Percentage of nights without awakenings due to asthma [Time Frame: during the last 3 weeks of the 6 week treatment period.] [Designated as safety issue: No]
  • • Proportion of subjects withdrawn due to lack of efficacy [Time Frame: during the last 3 weeks of the 6 week treatment period.] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleSafety and Efficacy Study Adding GSK2190915 to Mid-dose Inhaled Corticosteroid/Long Acting Beta Agonist Combination Treatment for Asthma
Official TitleA 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
ConditionAsthma
InterventionDrug: 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)
  • Experimental: FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
    FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
  • Active Comparator: FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
    FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
  • Placebo Comparator: FP/SAL 250/50mcg BID plus placebo BID
    P/SAL 250/50mcg BID plus placebo BID

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment145
Estimated Completion DateOctober 2011
Estimated Primary Completion DateOctober 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
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesBulgaria, Poland, Ukraine

Administrative Information[ + expand ][ + ]

NCT Number NCT01248975
Other Study ID Numbers114387
Has Data Monitoring CommitteeNo
Information Provided ByGlaxoSmithKline
Study SponsorGlaxoSmithKline
CollaboratorsNot Provided
Investigators Study Director: GSK Clinical Trials GlaxoSmithKline
Verification DateApril 2012

Locations[ + expand ][ + ]

GSK Investigational Site
Pleven, Bulgaria, 5800
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