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Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 2

Conditions

Asthma

Treatments

Drug: FP/SAL 100/50
Drug: placebo
Drug: FP 100
Drug: montelukast
Drug: GSK2190915 300
Drug: GSK2190915 100

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects > or = 12 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 or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 12 years of age over the course of 6 weeks treatment.

Enrollment

162 patients

Sex

Female

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: 12 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
  • 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 100mcg 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

162 participants in 5 patient groups

FP 100mcg BID plus GSK2190915 100mg QD (AM)
Experimental group
Description:
FP 100mcg BID plus GSK2190915 100mg QD (AM)
Treatment:
Drug: GSK2190915 100
Drug: FP 100
FP 100mcg BID plus GSK2190915 300mg QD (AM)
Experimental group
Description:
FP 100mcg BID plus GSK2190915 300mg QD (AM)
Treatment:
Drug: GSK2190915 300
Drug: FP 100
FP 100mcg BID plus montelukast 10mg QD (PM)
Active Comparator group
Description:
FP 100mcg BID plus montelukast 10mg QD (PM)
Treatment:
Drug: montelukast
Drug: FP 100
FP 100mcg BID plus placebo BID
Active Comparator group
Description:
FP 100mcg BID plus placebo BID
Treatment:
Drug: placebo
Drug: FP 100
FP/SAL 100/50mcg BID plus placebo BID
Active Comparator group
Description:
FP/SAL 100/50mcg BID plus placebo BID
Treatment:
Drug: placebo
Drug: FP/SAL 100/50

Trial contacts and locations

32

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Data sourced from clinicaltrials.gov

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