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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01156792
First received: July 1, 2010
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: FP 100
Drug: GSK2190915 100
Drug: GSK2190915 300
Drug: montelukast
Drug: placebo
Drug: FP/SAL 100/50
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Treatment, Four 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 100mg, GSK2190915 300mg, Montelukast 10mg or Placebo Tablets Once Daily or Salmeterol 50mcg Inhalation Powder Twice Daily to Fluticasone Propionate 100mcg Inhalation Powder Twice Daily in Uncontrolled Asthmatic Subjects ≥ 12 Years of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Trough (AM pre-dose and pre-rescue bronchodilator) FEV1 [ Time Frame: at the end of each 6 week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily trough (AM pre-dose and pre-rescue bronchodilator) AM peak expiratory flow [ Time Frame: averaged over the last 3 weeks of the 6 week treatment period. ] [ Designated as safety issue: No ]
  • Daily PM peak expiratory flow [ 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) peak expiratory flow [ 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 ]

Enrollment: 160
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FP 100mcg BID plus GSK2190915 100mg QD (AM)
FP 100mcg BID plus GSK2190915 100mg QD (AM)
Drug: FP 100
FP 100mcg BID
Drug: GSK2190915 100
GSK2190915 100mg QD (AM)
Experimental: FP 100mcg BID plus GSK2190915 300mg QD (AM)
FP 100mcg BID plus GSK2190915 300mg QD (AM)
Drug: FP 100
FP 100mcg BID
Drug: GSK2190915 300
GSK2190915 300mg QD (AM)
Active Comparator: FP 100mcg BID plus montelukast 10mg QD (PM)
FP 100mcg BID plus montelukast 10mg QD (PM)
Drug: FP 100
FP 100mcg BID
Drug: montelukast
montelukast 10mg QD (PM)
Active Comparator: FP 100mcg BID plus placebo BID
FP 100mcg BID plus placebo BID
Drug: FP 100
FP 100mcg BID
Drug: placebo
placebo BID
Active Comparator: FP/SAL 100/50mcg BID plus placebo BID
FP/SAL 100/50mcg BID plus placebo BID
Drug: placebo
placebo BID
Drug: FP/SAL 100/50
FP/SAL 100/50mcg BID

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156792

  Show 32 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01156792     History of Changes
Other Study ID Numbers: 114255
Study First Received: July 1, 2010
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
asthma
GSK2190915

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014