Last updated: 11/07/2018 05:34:47

GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

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GSK study ID
113073
See study documents
Clinicaltrials.gov ID
NCT00950807
See results summary
EudraCT ID
2009-014543-46
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 Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of GSK573719 Administered Once- and Twice-Daily in Subjects with COPD
Trial description: The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in trough forced expiratory volume in one second (FEV1) at Day 15 of each treatment period

Timeframe: Baseline and Day 15 of each treatment period (up to Study Day 71)

Secondary outcomes:

Change from Baseline (BL) in weighted mean FEV1 over 0 to 24 hours obtained post-dose on Day 14 of each treatment period

Timeframe: Baseline and Day 14 of each treatment period (TP; up to Study Day 70)

Change from Baseline (BL) in serial FEV1 over 0-28 hours after the morning dose at Day 14 of each treatment period

Timeframe: Baseline and Day (D) 14 of each treatment period (TP; up to Study Day 70)

Interventions:
  • Drug: Tiotropium
  • Drug: Placebo
  • Drug: GSK573179
    • Enrollment:
    176
    Primary completion date:
    2010-15-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Donohue JF, Anzueto A, Brooks J, Crater G, Mehta R, Kalberg C. A randomized, double-blind, dose-ranging study of the novel LAMA GSK573719 in patients with COPD. [Respir Med]. 2012;106(7):970-979.
    Donohue JF, Anzueto A, Brooks J, Crater G, Mehta R, Kalberg C. A randomized, double-blind, dose-ranging study of the novel LAMA GSK573719 in patients with COPD. Respir Med.2012;106(7):970-979.
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    umeclidinium bromide
    Collaborators
    GSK
    Study date(s)
    September 2009 to March 2010
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    40 - 80 years
    Accepts healthy volunteers
    No
    • A signed and dated written informed consent prior to study participation
    • Males or females of non-childbearing potential
    • 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 to 80 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 35 to 70% of predicted normal
    Exclusion criteria:
    • Asthma
    • Other significant respiratory disorders besides COPD, including alpha-1 deficiency
    • Previous lung resection surgery
    • Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening
    • Hospitalization for COPD or pneumonia within 3 months of 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 to 6 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

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Gaffney, South Carolina, United States, 29340
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10787
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hannover, Niedersachsen, Germany, 30159
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Greenville, South Carolina, United States, 29615
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Seneca, South Carolina, United States, 29678
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85013
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 19 Results

    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
    2010-15-03
    Actual study completion date
    2010-15-03

    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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