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Evaluate the Safety, Efficacy and Dose Response of GSK573719 in Combination With Fluticasone Furoate in Subjects With Asthma (ILA115938)

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: April 5, 2012
Last updated: August 14, 2014
Last verified: August 2014

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.

Condition Intervention Phase
Asthma Drug: FF/GSK573719 Drug: FF Drug: FF/VI Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: A Multi-center, Randomized, Double-blind, Dose-ranging Study to Evaluate GSK573719 in Combination With Fluticasone Furoate, Fluticasone Furoate Alone, and an Active Control of Fluticasone Furoate/Vilanterol Combination in Subjects With Asthma

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in Trough FEV1 [ Time Frame: Day 14 ]
    FEV1 value obtained 24 hours after morning dosing on day 14 of each treatment period

Secondary Outcome Measures:
  • Mean Change from baseline in Daily AM/PM Peak Expiratory Flow [ Time Frame: Day 7-14 ]
    Daily AM/PM (pre-dose and pre-rescue bronchodilator) PEF; calculated from the last 7 days of each treatment period

  • Mean Change from baseline in Rescue albuterol use [ Time Frame: Day 7-14 ]
    Rescue albuterol/salbutamol use calculated from the 7 days prior to each treatment period as baseline and the last 7 days of each treatment period

Enrollment: 421
Study Start Date: April 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluticasone Furoate (FF)
100mcg, inhaled
Drug: FF
Active Comparator: Fluticasone Furoate /Vilanterol (VI)
100/25mcg inhaled
Drug: FF/VI
Experimental: Fluticasone Furoate/GSK573719
100/15.6-250mcg inhaled
Drug: FF/GSK573719
Drug: FF/GSK573719
Drug: FF/GSK573719
Drug: FF/GSK573719
Drug: FF/GSK573719


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01573624

United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, South Carolina
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
GSK Investigational Site
Buenos Aires, Argentina, C1424BSF
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1425BEN
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
GSK Investigational Site
Mendoza, Argentina, M5500CCG
GSK Investigational Site
San Miguel de Tucumán, Argentina, 4000
GSK Investigational Site
Tucumán, Argentina, T4000DGF
GSK Investigational Site
Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500551
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500800
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 8880465
GSK Investigational Site
Talca, Región Metro De Santiago, Chile, 3460001
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2341131
GSK Investigational Site
Santiago, Chile, 8380453
Russian Federation
GSK Investigational Site
Barnaul, Russian Federation, 656038
GSK Investigational Site
Kazan, Russian Federation, 420015
GSK Investigational Site
Klin, Russian Federation, 141600
GSK Investigational Site
Moscow, Russian Federation, 115 280
GSK Investigational Site
Moscow, Russian Federation, 123367
GSK Investigational Site
Saint-Petersburg, Russian Federation, 194354
GSK Investigational Site
St. Petersburg, Russian Federation, 194356
GSK Investigational Site
Tomsk, Russian Federation, 634001
GSK Investigational Site
Tomsk, Russian Federation, 634055
GSK Investigational Site
Ufa, Russian Federation, 450071
GSK Investigational Site
Yaroslavl, Russian Federation, 150003
GSK Investigational Site
Bangkok, Thailand, 10330
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Khon Kaen, Thailand, 40002
GSK Investigational Site
Nonthaburi, Thailand, 11000
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT01573624     History of Changes
Other Study ID Numbers: 115938
Study First Received: April 5, 2012
Last Updated: August 14, 2014

Keywords provided by GlaxoSmithKline:
Vilanterol (VI),
, Fluticasone Furoate (FF),

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents processed this record on July 21, 2017