Last updated: 11/07/2018 05:40:41

Safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of GSK573719 and GW642444 in subjects with COPD

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GSK study ID
113120
See study documents
Clinicaltrials.gov ID
NCT01039675
See results summary
EudraCT ID
Not applicable
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: Safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of GSK573719 and GW642444 in subjects with COPD
Trial description: The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of inhaled GSK573719 and GW64244 compared to placebo, in subjects with COPD.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in weighted mean pulse rate over 0 to 6 hours post-dose at Day 28

Timeframe: Baseline and Day 28

Secondary outcomes:

Change from Baseline in weighted mean pulse rate over 0 to 6 hours post-dose at Day 1 and Day 14

Timeframe: Baseline, Day 1, and Day 14

Change from Baseline in maximum and minimum pulse rate 0 to 6 hours post-dose on Days 1, 14, and 28

Timeframe: Baseline, Day 1, Day 14 and Day 28

Interventions:
  • Drug: 500mcg/25mcg once daily
  • Drug: Placebo once daily
    • Enrollment:
    51
    Primary completion date:
    2010-20-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Feldman G, Walker RR, Brooks J, Mehta R, Crater G. 28-day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial. Pulm Pharmacol Ther. 2012;25(6):465-71.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    umeclidinium bromide, vilanterol
    Collaborators
    GSK
    Study date(s)
    January 2010 to April 2010
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • A signed and dated written informed consent prior to study participation
    • Males or females of non-childbearing potential
    • Current diagnosis of asthma
    • Other significant respiratory disorders besides COPD, including alpha-1 deficiency
    Inclusion and exclusion criteria
    Inclusion criteria:
    • A signed and dated written informed consent prior to study participation
    • Males or females of non-childbearing potential
    • 40 or more years of age
    • COPD diagnosis
    • 10 pack-years history or greater of cigarette smoking
    • Post-bronchodilator FEV1/FVC ratio of 0.70 or less
    • Post-bronchodilator FEV1 of 80% or less of predicted normal
    Exclusion criteria:
    • Current diagnosis of asthma
    • Other significant respiratory disorders besides COPD, including alpha-1 deficiency
    • Previous lung resection surgery
    • Significant abnormalities in chest x-ray presentation
    • Use of oral steroids, antibiotics or hospitalization for a COPD exacerbation within 3 motnhs prior screening
    • Any significant disease that would put subject at risk through study participation
    • BMI greater than 35
    • Pacemaker
    • Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or C)
    • Cancer
    • Allergy or hypersensitivity to anticholinergics or inhaler excipients
    • Diseases that would contra-indicate the use of anticholinergics
    • Use of oral corticosteroids within 6 weeks of screening
    • Use of long-acting beta-agonists within 48 hours of screening
    • Use of tiotropium within 14 days of screening
    • Use of theophyllines or anti-leukotrienes within 48 hours of screening
    • Use of short-acting bronchodilators within 4 hours of screening
    • Use of investigational medicines within 30 days of screening
    • Use of high dose inhaled corticosteroids
    • Use of long-term oxygen therapy, CPAP or NIPPV
    • Previous use of GSK573719 or GW642444

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Greenwood, South Carolina, United States, 29646
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Greenville, South Carolina, United States, 29615
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Gaffney, South Carolina, United States, 29340
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chester, South Carolina, United States, 29706
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    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
    2010-20-04
    Actual study completion date
    2010-20-04

    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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