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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156792
• Other study ID #: 114255
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2010
• Last updated: September 4, 2014
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: September 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• FP 100
FP 100mcg BID
• GSK2190915 100
GSK2190915 100mg QD (AM)
• GSK2190915 300
GSK2190915 300mg QD (AM)
• montelukast
montelukast 10mg QD (PM)
• placebo
placebo BID
• FP/SAL 100/50
FP/SAL 100/50mcg BID

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Bangor	Maine
United States	GSK Investigational Site	Bellevue	Nebraska
United States	GSK Investigational Site	Bethlehem	Pennsylvania
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Coral Gables	Florida
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Lenexa	Kansas
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Ocean	New Jersey
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Orangeburg	South Carolina
United States	GSK Investigational Site	Owensboro	Kentucky
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	South Burlington	Vermont
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Vista	California
United States	GSK Investigational Site	Waco	Texas
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough (AM pre-dose and pre-rescue bronchodilator) FEV1		at the end of each 6 week treatment period	No
Secondary	Daily trough (AM pre-dose and pre-rescue bronchodilator) AM peak expiratory flow		averaged over the last 3 weeks of the 6 week treatment period.	No
Secondary	Daily PM peak expiratory flow		averaged over the last 3 weeks of the 6 week treatment period.	No
Secondary	Daily (average of AM and PM) peak expiratory flow		averaged over the last 3 weeks of the 6 week treatment period.	No
Secondary	Daily asthma symptom score		averaged over the last 3 weeks of the 6 week treatment period.	No
Secondary	Daily rescue salbutamol use		averaged over the last 3 weeks of the 6 week treatment period.	No
Secondary	Percentage of symptom-free days		during the last 3 weeks of the 6 week treatment period.	No
Secondary	Percentage of symptom-free nights		during the last 3 weeks of the 6 week treatment period.	No
Secondary	Percentage of rescue-free days		during the last 3 weeks of the 6 week treatment period.	No
Secondary	Percentage of rescue-free nights		during the last 3 weeks of the 6 week treatment period.	No
Secondary	Percentage of nights without awakenings due to asthma		during the last 3 weeks of the 6 week treatment period.	No
Secondary	Proportion of subjects withdrawn due to lack of efficacy		during the last 3 weeks of the 6 week treatment period.	No