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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: GSK2190915 100mg QD (AM); Drug: FP/SAL 250/50mcg BID; Drug: Placebo tablets (2) (AM); Drug: GSK2190915 200mg QD (AM); Drug: Placebo capsule (PM); Drug: Montelukast 10mg QD (PM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01248975

114387

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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145 participants in 3 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: GSK2190915 200mg QD (AM)

Drug: FP/SAL 250/50mcg BID

Drug: GSK2190915 100mg QD (AM)

Drug: Placebo capsule (PM)

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

Active Comparator group

Description:

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

Treatment:

Drug: FP/SAL 250/50mcg BID

Drug: Placebo tablets (2) (AM)

Drug: Montelukast 10mg QD (PM)

FP/SAL 250/50mcg BID plus placebo BID

Placebo Comparator group

Description:

P/SAL 250/50mcg BID plus placebo BID

Treatment:

Drug: FP/SAL 250/50mcg BID

Drug: Placebo tablets (2) (AM)

Drug: Placebo capsule (PM)