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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01573624
First received: April 5, 2012
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
100
Active Comparator: Fluticasone Furoate /Vilanterol (VI)
100/25mcg inhaled
Drug: FF/VI
100/25
Experimental: Fluticasone Furoate/GSK573719
100/15.6-250mcg inhaled
Drug: FF/GSK573719
100/15.6
Drug: FF/GSK573719
100/31.25
Drug: FF/GSK573719
100/62.5
Drug: FF/GSK573719
100/125
Drug: FF/GSK573719
100/250

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573624

Locations
Argentina
GSK Investigational Site
Mendoza, Argentina, M5500CCG
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01573624     History of Changes
Other Study ID Numbers: 115938
Study First Received: April 5, 2012
Last Updated: July 25, 2013
Health Authority: Chile: SFDA -State Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
United States: Institutional Review Board
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Russian Federation: Ministry of Health and social development of Russian Federation, Federal
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Vilanterol (VI),
, Fluticasone Furoate (FF),
Adults
Asthma
GSK573719,

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 23, 2014