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

NCT01248975 | Completed Phase 2

• 1 other identifier: 114387
• Study Type: interventional
• Target: 145
• Locations: 3 countries
• Sites: 19

Brief Summary

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.

Conditions

Asthma

Keywords

asthma; GSK2190915

Outcome Measures

Primary Outcomes (1)

• Trough (AM pre-dose and pre-rescue bronchodilator) FEV1

  at the end of the 6 week treatment period.

Secondary Outcomes (11)

• • Daily trough (AM pre-dose and pre-rescue bronchodilator) AM PEF

  averaged over the last 3 weeks of the 6 week treatment period.

• • Daily PM PEF

  averaged over the last 3 weeks of the 6 week treatment period.

• • Daily (average of AM and PM)

  averaged over the last 3 weeks of the 6 week treatment period

• • Daily asthma symptom score

  averaged over the last 3 weeks of the 6 week treatment period.

• • Daily rescue salbutamol use

  averaged over the last 3 weeks of the 6 week treatment period.

Study Arms (3)

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

EXPERIMENTAL

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

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

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

ACTIVE COMPARATOR

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

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

FP/SAL 250/50mcg BID plus placebo BID

PLACEBO COMPARATOR

P/SAL 250/50mcg BID plus placebo BID

Drug: FP/SAL 250/50mcg BID; Drug: Placebo tablets (2) (AM); Drug: Placebo capsule (PM)

Interventions

FP/SAL 250/50mcg BID DRUG

FP/SAL 250/50mcg BID

FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM); FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM); FP/SAL 250/50mcg BID plus placebo BID

GSK2190915 200mg QD (AM) DRUG

GSK2190915 200mg QD (AM)

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

GSK2190915 100mg QD (AM) DRUG

GSK2190915 100mg QD (AM)

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

Montelukast 10mg QD (PM) DRUG

Montelukast 10mg QD (PM)

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

Placebo tablets (2) (AM) DRUG

Placebo tablets (2) (AM)

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

Placebo capsule (PM) DRUG

Placebo capsule (PM)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (19)

GSK Investigational Site

Pleven, 5800, Bulgaria

Location

GSK Investigational Site

Rousse, 7000, Bulgaria

Location

GSK Investigational Site

Varna, 9010, Bulgaria

Location

GSK Investigational Site

Bialystok, 15-084, Poland

Location

GSK Investigational Site

Lodz, 93-329, Poland

Location

GSK Investigational Site

Tarnów, 33-100, Poland

Location

GSK Investigational Site

Dnipropetrovsk, 49027, Ukraine

Location

GSK Investigational Site

Dnipropetrovsk, 49051, Ukraine

Location

GSK Investigational Site

Donetsk, 83099, Ukraine

Location

GSK Investigational Site

Ivano-Frankivsk, 76018, Ukraine

Location

GSK Investigational Site

Kharkiv, 61035, Ukraine

Location

GSK Investigational Site

Kharkiv, 61037, Ukraine

Location

GSK Investigational Site

Kiev, 03680, Ukraine

Location

GSK Investigational Site

Kiev, 3680, Ukraine

Location

GSK Investigational Site

Kyiv, 02091, Ukraine

Location

GSK Investigational Site

Kyiv, 02232, Ukraine

Location

GSK Investigational Site

Kyiv, 03115, Ukraine

Location

GSK Investigational Site

Kyiv, 04107, Ukraine

Location

GSK Investigational Site

Zaporizhia, 69035, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 24010736 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Interventions

BID protein, human; 3-(3-tert-butylsulfanyl-1-(4-(6-ethoxypyridin-3-yl)benzyl)-5-(5-methylpyridin-2-ylmethoxy)-1H-indol-2-yl)-2,2-dimethylpropionic acid; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 25, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 25, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

PL (3); UA (13); BU (3)