Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

421 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-03

Study Completion Date

2013-02-04

Brief Summary

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Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.

Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. Most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. This is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. The total duration of subject participation is approximately 14 weeks.

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

DOUBLE

Participants Investigators

Study Groups

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Fluticasone Furoate (FF)

100mcg, inhaled

Group Type ACTIVE_COMPARATOR

FF

Intervention Type DRUG

100

Fluticasone Furoate /Vilanterol (VI)

100/25mcg inhaled

Group Type ACTIVE_COMPARATOR

FF/VI

Intervention Type DRUG

100/25

Fluticasone Furoate/GSK573719

100/15.6-250mcg inhaled

Group Type EXPERIMENTAL

FF/GSK573719

Intervention Type DRUG

100/15.6

FF/GSK573719

Intervention Type DRUG

100/31.25

FF/GSK573719

Intervention Type DRUG

100/62.5

FF/GSK573719

Intervention Type DRUG

100/125

FF/GSK573719

Intervention Type DRUG

100/250

Interventions

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FF/GSK573719

100/15.6

Intervention Type DRUG

FF/GSK573719

100/31.25

Intervention Type DRUG

FF/GSK573719

100/62.5

Intervention Type DRUG

FF/GSK573719

100/125

Intervention Type DRUG

FF/GSK573719

100/250

Intervention Type DRUG

FF

100

Intervention Type DRUG

FF/VI

100/25

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Outpatient
* 18 years of age or older at Visit 1
* Diagnosis of Asthma
* Male or eligible Female
* Pre-bronchodilator FEV1 of 40-80% of the predicted normal value at Visit 1
* Demonstrated reversibility by ≥12% and ≥200mL of FEV1 within 40 minutes following albuterol at Visit 1
* A need for regular controller therapy (i.e., inhaled corticosteroids alone or in combination with a long-acting beta-agonist, or leukotriene modifier etc.,) for a minimum of 8 weeks prior to Visit 1.

Exclusion Criteria

* History of Life threatening asthma
* Respiratory infection not resolved
* Asthma exacerbation
* Concurrent respiratory disease
* Current Smokers
* Other diseases that are uncontrolled disease or disease state that, in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study
* A positive Hepatitis B surface antigen or positive Hepatitis C antibody and/or HIV
* Visual clinical evidence of oropharyngeal candidiasis
* Drug or milk protein allergies
* Concomitant medications affecting course of asthma
* Use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer)
* Previous use of GSK573719
* Any disease preventing use of anticholinergics
* Any condition that impairs compliance with study protocol including visit schedule and completion of daily diaries
* Any subject with a history of alcohol or substance abuse
* Any affiliation with Investigator's site

Minimum Eligible Age

18 Years

Eligible Sex

ALL

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

St Louis, Missouri, United States

Site Status

GSK Investigational Site

Medford, Oregon, United States

Site Status

GSK Investigational Site

Orangeburg, South Carolina, United States

Site Status

GSK Investigational Site

Spartanburg, South Carolina, United States

Site Status

GSK Investigational Site

Buenos Aires, , Argentina

Site Status

GSK Investigational Site

Buenos Aires, , Argentina

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GSK Investigational Site

Buenos Aires, , Argentina

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GSK Investigational Site

Mendoza, , Argentina

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GSK Investigational Site

San Miguel de Tucumán, , Argentina

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GSK Investigational Site

San Miguel de Tucumán, , Argentina

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GSK Investigational Site

Valparaíso, Región de Valparaíso, Chile

Site Status

GSK Investigational Site

Puente Alto - Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

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GSK Investigational Site

Talca, Región Metro de Santiago, Chile

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GSK Investigational Site

Santiago, , Chile

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GSK Investigational Site

Barnaul, , Russia

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GSK Investigational Site

Kazan', , Russia

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GSK Investigational Site

Klin, , Russia

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GSK Investigational Site

Moscow, , Russia

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GSK Investigational Site

Moscow, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Tomsk, , Russia

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GSK Investigational Site

Tomsk, , Russia

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GSK Investigational Site

Ufa, , Russia

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GSK Investigational Site

Yaroslavl, , Russia

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GSK Investigational Site

Bangkok, , Thailand

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GSK Investigational Site

Bangkok, , Thailand

Site Status

GSK Investigational Site

Khon Kaen, , Thailand

Site Status

GSK Investigational Site

Nonthaburi, , Thailand

Site Status

Countries

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United States Argentina Chile Russia Thailand

References

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Lee LA, Yang S, Kerwin E, Trivedi R, Edwards LD, Pascoe S. The effect of fluticasone furoate/umeclidinium in adult patients with asthma: a randomized, dose-ranging study. Respir Med. 2015 Jan;109(1):54-62. doi: 10.1016/j.rmed.2014.09.012. Epub 2014 Oct 2.

Reference Type DERIVED

PMID: 25452139 (View on PubMed)

Study Documents

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