Last updated: 11/07/2018 09:59:52

Evaluate the safety, efficacy and dose response of GSK573719 in combination with Fluticasone Furoate in subjects with asthmaILA115938

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GSK study ID
115938
See study documents
Clinicaltrials.gov ID
NCT01573624
See results summary
EudraCT ID
2011-004328-37
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Model predicted change from baseline trough force expiratory volume in 1 second (FEV1)

Timeframe: Baseline (Day 1) and Day 15 of each treatment period

Percentage of chance that FF 100 mcg alone corrected change from baseline FEV1 response would exceed a target response by dose of UMEC combined with FF 100 mcg

Timeframe: Baseline (Day 1) and Day 15 of each treatment period

Mean change from baseline in trough FEV1 on Day 15 of each of the 3 treatment periods

Timeframe: Baseline (Day 1) and Day 15 of each treatment period

Secondary outcomes:

Mean change from baseline in daily morning (pre-dose and pre-rescue bronchodilator) peak expiratory flow (PEF) of each treatment period

Timeframe: Baseline (Week 0) and last 7 days of each treatment period

Mean change from baseline in daily evening (pre-dose and pre-rescue bronchodilator) PEF of each treatment period

Timeframe: Baseline (Week 0) and last 7 days of each treatment period

Mean change from baseline in rescue albuterol/salbutamol use of each treatment period.

Timeframe: Baseline (Week 0) and last 7 days of each treatment period

Interventions:
  • Drug: FF/GSK573719
  • Drug: FF
  • Drug: FF/VI
    • Enrollment:
    421
    Primary completion date:
    2013-04-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Laurie A. Lee, Shuying Yang, Edward Kerwin, Roopa Trivedi, Lisa D. Edwards, Steven Pascoe.The effect of fluticasone furoate/umeclidinium in adult patients with asthma: A randomized, dose-ranging study.Respir Med.2015;109(1):54-62
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone furoate/umeclidinium bromide, fluticasone furoate/vilanterol, umeclidinium bromide
    Collaborators
    Not applicable
    Study date(s)
    April 2012 to February 2013
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Outpatient
    • 18 years of age or older at Visit 1
    • History of Life threatening asthma
    • Respiratory infection not resolved
    Inclusion and exclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Klin, Russia, 141600
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Santiago, Región Metro De Santiago, Chile, 7500551
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tomsk, Russia, 634001
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mendoza, Mendoza, Argentina, M5500CCG
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ciudad Autonoma de Buenos Aires, Argentina, C1425BEN
    Status
    Study Complete
    Contact us
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2013-04-02
    Actual study completion date
    2013-04-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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