Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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FP 100mcg BID plus GSK2190915 100mg QD (AM)

Group Type EXPERIMENTAL

FP 100

Intervention Type DRUG

FP 100mcg BID

GSK2190915 100

Intervention Type DRUG

GSK2190915 100mg QD (AM)

FP 100mcg BID plus GSK2190915 300mg QD (AM)

Group Type EXPERIMENTAL

FP 100

Intervention Type DRUG

FP 100mcg BID

GSK2190915 300

Intervention Type DRUG

GSK2190915 300mg QD (AM)

FP 100mcg BID plus montelukast 10mg QD (PM)

Group Type ACTIVE_COMPARATOR

FP 100

Intervention Type DRUG

FP 100mcg BID

montelukast

Intervention Type DRUG

montelukast 10mg QD (PM)

FP 100mcg BID plus placebo BID

Group Type ACTIVE_COMPARATOR

FP 100

Intervention Type DRUG

FP 100mcg BID

placebo

Intervention Type DRUG

placebo BID

FP/SAL 100/50mcg BID plus placebo BID

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type DRUG

placebo BID

FP/SAL 100/50

Intervention Type DRUG

FP/SAL 100/50mcg BID

Interventions

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FP 100

FP 100mcg BID

Intervention Type DRUG

GSK2190915 100

GSK2190915 100mg QD (AM)

Intervention Type DRUG

GSK2190915 300

GSK2190915 300mg QD (AM)

Intervention Type DRUG

montelukast

montelukast 10mg QD (PM)

Intervention Type DRUG

placebo

placebo BID

Intervention Type DRUG

FP/SAL 100/50

FP/SAL 100/50mcg BID

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

Huntington Beach, California, United States

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GSK Investigational Site

Los Angeles, California, United States

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GSK Investigational Site

Vista, California, United States

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GSK Investigational Site

Coral Gables, Florida, United States

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GSK Investigational Site

Miami, Florida, United States

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GSK Investigational Site

Indianapolis, Indiana, United States

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GSK Investigational Site

Lenexa, Kansas, United States

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GSK Investigational Site

Owensboro, Kentucky, United States

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GSK Investigational Site

Metairie, Louisiana, United States

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GSK Investigational Site

Bangor, Maine, United States

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GSK Investigational Site

Ypsilanti, Michigan, United States

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GSK Investigational Site

Minneapolis, Minnesota, United States

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GSK Investigational Site

St Louis, Missouri, United States

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GSK Investigational Site

St Louis, Missouri, United States

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GSK Investigational Site

Bellevue, Nebraska, United States

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GSK Investigational Site

Ocean City, New Jersey, United States

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GSK Investigational Site

Wilmington, North Carolina, United States

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GSK Investigational Site

Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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GSK Investigational Site

Bethlehem, Pennsylvania, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, United States

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GSK Investigational Site

Orangeburg, South Carolina, United States

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GSK Investigational Site

Austin, Texas, United States

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GSK Investigational Site

Dallas, Texas, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Plano, Texas, United States

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GSK Investigational Site

Waco, Texas, United States

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GSK Investigational Site

South Burlington, Vermont, United States

Site Status

GSK Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Snowise NG, Clements D, Ho SY, Follows RM. Addition of a 5-lipoxygenase-activating protein inhibitor to an inhaled corticosteroid (ICS) or an ICS/long-acting beta-2-agonist combination in subjects with asthma. Curr Med Res Opin. 2013 Dec;29(12):1663-74. doi: 10.1185/03007995.2013.842163. Epub 2013 Sep 19.

Reference Type DERIVED

PMID: 24010736 (View on PubMed)

Study Documents

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