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Completed

NCT Number: NCT01248975

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Pleven, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FP/SAL 250/50mcg BID

Drug

FP/SAL 250/50mcg BID

GSK2190915 200mg QD (AM)

Drug

GSK2190915 200mg QD (AM)

GSK2190915 100mg QD (AM)

Drug

GSK2190915 100mg QD (AM)

Montelukast 10mg QD (PM)

Drug

Montelukast 10mg QD (PM)

Placebo tablets (2) (AM)

Drug

Placebo tablets (2) (AM)

Placebo capsule (PM)

Drug

Placebo capsule (PM)

Primary outcomes

  1. Trough (AM pre-dose and pre-rescue bronchodilator) FEV1

    Time frame: at the end of the 6 week treatment period.

Secondary outcomes

  1. • 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.

  2. • Daily PM PEF

    Time frame: averaged over the last 3 weeks of the 6 week treatment period.

  3. • Daily (average of AM and PM)

    Time frame: averaged over the last 3 weeks of the 6 week treatment period

  4. • Daily asthma symptom score

    Time frame: averaged over the last 3 weeks of the 6 week treatment period.

  5. • Daily rescue salbutamol use

    Time frame: averaged over the last 3 weeks of the 6 week treatment period.

  6. • Percentage of symptom-free days

    Time frame: during the last 3 weeks of the 6 week treatment period.

  7. • Percentage of symptom-free nights

    Time frame: during the last 3 weeks of the 6 week treatment period.

  8. • Percentage of rescue-free days

    Time frame: during the last 3 weeks of the 6 week treatment period.

  9. • Percentage of rescue-free nights

    Time frame: during the last 3 weeks of the 6 week treatment period.

  10. • Percentage of nights without awakenings due to asthma

    Time frame: during the last 3 weeks of the 6 week treatment period.

  11. • Proportion of subjects withdrawn due to lack of efficacy

    Time frame: during the last 3 weeks of the 6 week treatment period.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 25, 2010
Registry last updated
Nov 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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