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Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily

NCT ID: NCT01147744

Last Updated: 2017-10-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-28

Study Completion Date

2011-10-06

Brief Summary

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To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of age and older) with persistent asthma. These data will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried forward in Phase III asthma studies. The study also includes Fluticasone Propionate Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid and a leukotriene receptor antagonist.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GSK2190915 10mg and placebo

GSK2190915 10mg (1 x 10mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS

Group Type EXPERIMENTAL

GSK2190915 10mg

Intervention Type DRUG

GSK2190915 10mg (1 x 10mg) once daily in the morning

Placebo GSK2190915 one tablet

Intervention Type DRUG

Placebo tablet, one tablet once daily in the morning

Placebo montelukast

Intervention Type DRUG

Placebo capsule once daily in the evening

Placebo fluticasone propionate via ACCUHALER/DISKUS

Intervention Type DRUG

Inhaled placebo twice daily via ACCUHALER/DISKUS

GSK2190915 30mg and placebo

GSK2190915 30mg (1 x 30mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS

Group Type EXPERIMENTAL

GSK2190915 30mg

Intervention Type DRUG

GSK2190915 30mg (1 x 30mg) once daily in the morning

Placebo GSK2190915 one tablet

Intervention Type DRUG

Placebo tablet, one tablet once daily in the morning

Placebo montelukast

Intervention Type DRUG

Placebo capsule once daily in the evening

Placebo fluticasone propionate via ACCUHALER/DISKUS

Intervention Type DRUG

Inhaled placebo twice daily via ACCUHALER/DISKUS

GSK2190915 100mg QD and placebo

GSK2190915 100mg (1 x 100mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS

Group Type EXPERIMENTAL

GSK2190915 100mg

Intervention Type DRUG

GSK2190915 100mg (1 x 100mg) once daily in the morning

Placebo GSK2190915 one tablet

Intervention Type DRUG

Placebo tablet, one tablet once daily in the morning

Placebo montelukast

Intervention Type DRUG

Placebo capsule once daily in the evening

Placebo fluticasone propionate via ACCUHALER/DISKUS

Intervention Type DRUG

Inhaled placebo twice daily via ACCUHALER/DISKUS

GSK2190915 300mg QD and placebo

GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS

Group Type EXPERIMENTAL

GSK2190915 300mg

Intervention Type DRUG

GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning

Placebo montelukast

Intervention Type DRUG

Placebo capsule once daily in the evening

Placebo fluticasone propionate via ACCUHALER/DISKUS

Intervention Type DRUG

Inhaled placebo twice daily via ACCUHALER/DISKUS

Fluticasone propionate 100mcg and placebo

Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS and two placebo tablets in the morning and one placebo capsule in the evening

Group Type ACTIVE_COMPARATOR

Fluticasone Propionate 100mcg via ACCUHALER/DISKUS

Intervention Type DRUG

Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS

Placebo montelukast

Intervention Type DRUG

Placebo capsule once daily in the evening

Placebo GSK2190915 two tablets

Intervention Type DRUG

Placebo tablet, two tablets once daily in the morning

Montelukast 10mg and placebo

Montelukast 10mg (1 x 10mg capsule) once daily in the evening and two placebo tablets in the morning and inhaled placebo twice daily via ACCUHALER/DISKUS

Group Type ACTIVE_COMPARATOR

Montelukast 10mg

Intervention Type DRUG

Montelukast 10mg (1 x 10mg capsule) once daily in the evening

Placebo fluticasone propionate via ACCUHALER/DISKUS

Intervention Type DRUG

Inhaled placebo twice daily via ACCUHALER/DISKUS

Placebo GSK2190915 two tablets

Intervention Type DRUG

Placebo tablet, two tablets once daily in the morning

Placebo Comparator

Two GSK2190915 placebo tablets once daily in the morning, montelukast placebo capsule once daily in the evening and fluticasone propionate placebo twice daily via ACCUHALER/DISKUS

Group Type PLACEBO_COMPARATOR

Placebo montelukast

Intervention Type DRUG

Placebo capsule once daily in the evening

Placebo fluticasone propionate via ACCUHALER/DISKUS

Intervention Type DRUG

Inhaled placebo twice daily via ACCUHALER/DISKUS

Placebo GSK2190915 two tablets

Intervention Type DRUG

Placebo tablet, two tablets once daily in the morning

Interventions

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Fluticasone Propionate 100mcg via ACCUHALER/DISKUS

Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS

Intervention Type DRUG

GSK2190915 100mg

GSK2190915 100mg (1 x 100mg) once daily in the morning

Intervention Type DRUG

GSK2190915 10mg

GSK2190915 10mg (1 x 10mg) once daily in the morning

Intervention Type DRUG

GSK2190915 300mg

GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning

Intervention Type DRUG

GSK2190915 30mg

GSK2190915 30mg (1 x 30mg) once daily in the morning

Intervention Type DRUG

Montelukast 10mg

Montelukast 10mg (1 x 10mg capsule) once daily in the evening

Intervention Type DRUG

Placebo GSK2190915 one tablet

Placebo tablet, one tablet once daily in the morning

Intervention Type DRUG

Placebo montelukast

Placebo capsule once daily in the evening

Intervention Type DRUG

Placebo fluticasone propionate via ACCUHALER/DISKUS

Inhaled placebo twice daily via ACCUHALER/DISKUS

Intervention Type DRUG

Placebo GSK2190915 two tablets

Placebo tablet, two tablets once daily in the morning

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type of Subject: Outpatient
* Age: ≥12 years of age
* Gender: Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
* Asthma Diagnosis: As defined by NIH
* Severity of Disease: FEV1 50-85% predicted AND in current and former smokers a post salbutamol/albuterol ratio \>0.70
* Reversibility: ≥12% and ≥200mL in FEV1 within 30 ±15 minutes following salbutamol/albuterol
* Current anti-asthma therapy: Using short-acting beta-agonist (SABA) for ≥3 months
* Tobacco use: Non-smoker /former smoker with ≤10 pack years or current smoker with ≤10 pack years
* QTC: QTc(F)\<450msec or QTc(F)\<480 for subjects with Bundle Branch Block
* Liver function: Normal liver function
* Informed Consent

Exclusion Criteria

* History of Life-threatening asthma: Within previous 5 years
* Asthma Exacerbation: Requiring OCS within 3 months or hospitalisation within 6 months
* Respiratory Infection: Not resolved within the 4 weeks before V1 AND led to a change in asthma management OR treatment with antibiotics OR is expected to affect the subject's asthma status or ability to participate
* Corticosteroid Use: ICS used within 6 weeks or OCS/depot corticosteroids within 12 weeks
* OATP1B1 substrates: OATP1B1 substrates (e.g. statins, rifampicin, bromosulphophthalein, benzylpenicillin, methotrexate) within 4 weeks
* Immunosuppressive medications: Either using or required during the study
* Liver disease: Current or chronic history
* Concurrent disease/abnormalities: Clinically significant uncontrolled disease
* Investigational medications: Participation in a study or used investigational drug within 30 days
* Drug allergy: β-agonists, corticosteroids, constituents of inhalers
* Milk Protein Allergy: History of severe milk protein allergy
* Compliance: Factors likely to impair compliance either with regards to study medication, procedures or attendance
* Unable or unwilling to follow instructions: Procedures, dosing directions, e-diaries or pMDIs
* History of alcohol or drug abuse: Likely to interfere with the study
* Affiliation with Investigator's Site: Relative or employee
Minimum Eligible Age

12 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

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

Huntington Beach, California, United States

Site Status

GSK Investigational Site

Newport Beach, California, United States

Site Status

GSK Investigational Site

San Diego, California, United States

Site Status

GSK Investigational Site

Tallahassee, Florida, United States

Site Status

GSK Investigational Site

Owensboro, Kentucky, United States

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GSK Investigational Site

Metairie, Louisiana, United States

Site Status

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

Columbia, Missouri, United States

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GSK Investigational Site

Rolla, Missouri, United States

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GSK Investigational Site

St Louis, Missouri, United States

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GSK Investigational Site

Ocean City, New Jersey, United States

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GSK Investigational Site

Raleigh, North Carolina, United States

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GSK Investigational Site

Canton, Ohio, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, United States

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GSK Investigational Site

Medford, Oregon, United States

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GSK Investigational Site

Orangeburg, South Carolina, United States

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GSK Investigational Site

San Antonio, Texas, United States

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GSK Investigational Site

Waco, Texas, United States

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GSK Investigational Site

Bellingham, Washington, United States

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GSK Investigational Site

Pleven, , Bulgaria

Site Status

GSK Investigational Site

Plovdiv, , Bulgaria

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GSK Investigational Site

Rousse, , Bulgaria

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GSK Investigational Site

Sofia, , Bulgaria

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GSK Investigational Site

Sofia, , Bulgaria

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GSK Investigational Site

Sofia, , Bulgaria

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GSK Investigational Site

Sofia, , Bulgaria

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GSK Investigational Site

Stara Zagora, , Bulgaria

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GSK Investigational Site

Varna, , Bulgaria

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GSK Investigational Site

Chiba, , Japan

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GSK Investigational Site

Fukuoka, , Japan

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GSK Investigational Site

Fukuoka, , Japan

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GSK Investigational Site

Hokkaido, , Japan

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GSK Investigational Site

Hokkaido, , Japan

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GSK Investigational Site

Ibaraki, , Japan

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GSK Investigational Site

Kanagawa, , Japan

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GSK Investigational Site

Osaka, , Japan

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GSK Investigational Site

Osaka, , Japan

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GSK Investigational Site

Saitama, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Bialystok, , Poland

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GSK Investigational Site

Katowice, , Poland

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GSK Investigational Site

Krakow, , Poland

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GSK Investigational Site

Libiąż, , Poland

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GSK Investigational Site

Lodz, , Poland

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GSK Investigational Site

Poznan, , Poland

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GSK Investigational Site

Tarnów, , Poland

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GSK Investigational Site

Brasov, , Romania

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GSK Investigational Site

Bucharest, , Romania

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GSK Investigational Site

Bucharest, , Romania

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GSK Investigational Site

Bucharest, , Romania

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GSK Investigational Site

Cluj-Napoca, , Romania

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GSK Investigational Site

Cluj-Napoca, , Romania

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GSK Investigational Site

Deva, , Romania

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GSK Investigational Site

Timișoara, , Romania

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GSK Investigational Site

Dnipropetrovsk, , Ukraine

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GSK Investigational Site

Dnipropetrovsk, , Ukraine

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GSK Investigational Site

Dnipropetrovsk, , Ukraine

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GSK Investigational Site

Donetsk, , Ukraine

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GSK Investigational Site

Ivano-Frankivsk, , Ukraine

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GSK Investigational Site

Kharkiv, , Ukraine

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GSK Investigational Site

Kharkiv, , Ukraine

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GSK Investigational Site

Kharkiv, , Ukraine

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GSK Investigational Site

Kiev, , Ukraine

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GSK Investigational Site

Kyiv, , Ukraine

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GSK Investigational Site

Kyiv, , Ukraine

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GSK Investigational Site

Kyiv, , Ukraine

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GSK Investigational Site

Kyiv, , Ukraine

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GSK Investigational Site

Kyiv, , Ukraine

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GSK Investigational Site

Kyiv, , Ukraine

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GSK Investigational Site

Odesa, , Ukraine

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GSK Investigational Site

Simferopol, , Ukraine

Site Status

GSK Investigational Site

Yalta, , Ukraine

Site Status

GSK Investigational Site

Zaporizhia, , Ukraine

Site Status

Countries

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United States Bulgaria Japan Poland Romania Ukraine

References

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Follows RM, Snowise NG, Ho SY, Ambery CL, Smart K, McQuade BA. Efficacy, safety and tolerability of GSK2190915, a 5-lipoxygenase activating protein inhibitor, in adults and adolescents with persistent asthma: a randomised dose-ranging study. Respir Res. 2013 May 17;14(1):54. doi: 10.1186/1465-9921-14-54.

Reference Type DERIVED
PMID: 23682661 (View on PubMed)

Study Documents

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Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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112186

Identifier Type: -

Identifier Source: org_study_id