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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

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 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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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

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)

Group Type EXPERIMENTAL

FP/SAL 250/50mcg BID

Intervention Type DRUG

FP/SAL 250/50mcg BID

GSK2190915 200mg QD (AM)

Intervention Type DRUG

GSK2190915 200mg QD (AM)

GSK2190915 100mg QD (AM)

Intervention Type DRUG

GSK2190915 100mg QD (AM)

Placebo capsule (PM)

Intervention Type DRUG

Placebo capsule (PM)

FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)

Group Type ACTIVE_COMPARATOR

FP/SAL 250/50mcg BID

Intervention Type DRUG

FP/SAL 250/50mcg BID

Montelukast 10mg QD (PM)

Intervention Type DRUG

Montelukast 10mg QD (PM)

Placebo tablets (2) (AM)

Intervention Type DRUG

Placebo tablets (2) (AM)

FP/SAL 250/50mcg BID plus placebo BID

P/SAL 250/50mcg BID plus placebo BID

Group Type PLACEBO_COMPARATOR

FP/SAL 250/50mcg BID

Intervention Type DRUG

FP/SAL 250/50mcg BID

Placebo tablets (2) (AM)

Intervention Type DRUG

Placebo tablets (2) (AM)

Placebo capsule (PM)

Intervention Type DRUG

Placebo capsule (PM)

Interventions

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FP/SAL 250/50mcg BID

Intervention Type DRUG

GSK2190915 200mg QD (AM)

Intervention Type DRUG

GSK2190915 100mg QD (AM)

Intervention Type DRUG

Montelukast 10mg QD (PM)

Intervention Type DRUG

Placebo tablets (2) (AM)

Intervention Type DRUG

Placebo capsule (PM)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 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

Pleven, , Bulgaria

Site Status

GSK Investigational Site

Rousse, , Bulgaria

Site Status

GSK Investigational Site

Varna, , Bulgaria

Site Status

GSK Investigational Site

Bialystok, , Poland

Site Status

GSK Investigational Site

Lodz, , Poland

Site Status

GSK Investigational Site

Tarnów, , Poland

Site Status

GSK Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

GSK Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

GSK Investigational Site

Donetsk, , Ukraine

Site Status

GSK Investigational Site

Ivano-Frankivsk, , Ukraine

Site Status

GSK Investigational Site

Kharkiv, , Ukraine

Site Status

GSK Investigational Site

Kharkiv, , Ukraine

Site Status

GSK Investigational Site

Kiev, , Ukraine

Site Status

GSK Investigational Site

Kiev, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Zaporizhia, , Ukraine

Site Status

Countries

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Bulgaria Poland Ukraine

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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