Last updated: 11/07/2018 05:55:03

A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled study to evaluate the safety and tolerability of GSK573719/GW642444 and GSK573719 in subjects with Chronic Obstructive Pulmonary Disease (COPD)COPD nDPI

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GSK study ID
113359
See study documents
Clinicaltrials.gov ID
NCT01316887
See results summary
EudraCT ID
2010-023417-54
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 52 week Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 125mcg once-daily alone and in combination with GW642444 25mcg once-daily via novel Dry Powder Inhaler (nDPI) in Subjects with Chronic Obstructive Pulmonary Disease
Trial description: The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of participants with any on-treatment adverse event (AE) or any serious adverse event (SAE)

Timeframe: From the start of study drug up to 52 weeks

Secondary outcomes:

Number of participants with at least one chronic obstructive pulmonary disease (COPD) exacerbation over the course of the 52-week Treatment Period

Timeframe: From the start of study drug up to 52 weeks

Time to the first on-treatment COPD exacerbation

Timeframe: From the start of study drug up to 52 weeks

Change from Baseline in alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatine kinase (CK), and gamma glutamyl transferase (GGT) at Months 3, 6, 9, and 12

Timeframe: Baseline; Months 3, 6, 9, and 12

Change from Baseline in albumin, total protein, and hemoglobin at Months 3, 6, 9, and 12

Timeframe: Baseline; Months 3, 6, 9, and 12

Change from Baseline in calcium, carbon dioxide (CO2) content/bicarbonate, chloride, glucose, inorganic phosphorus (IP), potassium, sodium, and urea/blood urea nitrogen (BUN) at Months 3, 6, 9, and 12

Timeframe: Baseline; Months 3, 6, 9, and 12

Change from Baseline in creatinine, direct bilirubin, indirect bilirubin, total bilirubin, and uric acid at Months 3, 6, 9, and 12

Timeframe: Baseline; Months 3, 6, 9, and 12

Change from Baseline in the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils in blood at Months 3, 6, 9, and 12

Timeframe: Baseline; Months 3, 6, 9, and 12

Change from Baseline in eosinophil count, platelet count, and white blood cell (WBC) count at Months 3, 6, 9, and 12

Timeframe: Baseline; Months 3, 6, 9, and 12

Change from Baseline in hematocrit at Months 3, 6, 9, and 12

Timeframe: Baseline; Months 3, 6, 9, and 12

Change from Baseline to maximum systolic blood pressure (SBP) and change from Baseline to minimum diastolic blood pressure (DBP) over the course of the 52-week Treatment Period

Timeframe: Baseline; from the start of study drug up to 52 weeks

Maximum change from Baseline in pulse rate over the course of the 52-week Treatment Period

Timeframe: Baseline; from the start of study drug up to 52 weeks

Maximum change from Baseline in the electrocardiogram (ECG) parameters of QT interval corrected for heart rate by Bazett’s formula (QTcB), QT interval corrected for heart rate by Fridericia’s formula (QTcF), and PR interval over the course of the 52-week

Timeframe: Baseline; from the start of study drug up to 52 weeks

Maximum change from Baseline in the ECG parameter of heart rate over the course of the 52-week Treatment Period

Timeframe: Baseline; from the start of study drug up to 52 weeks

Number of participants with the indicated ECG result interpretations at any time post-Baseline

Timeframe: From the start of study drug up to 52 weeks

Number of participants with the indicated change from screening to any time post-Baseline in Holter ECG interpretation

Timeframe: Screening; from the start of study drug up to 52 weeks

Change from Baseline in the mean number of puffs of rescue medication (salbutamol and/or ipratropium bromide) per day over the course of the 52-week Treatment Period

Timeframe: Baseline; from the start of study drug up to 52 weeks

Change from Baseline in the percentage of rescue-free days over the course of the 52-week Treatment Period

Timeframe: From the start of study drug up to 52 weeks

Change from Baseline in trough forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) at Months 1, 3, 6, 9, and 12

Timeframe: Baseline; Months 1, 3, 6, 9, and 12

Interventions:
  • Drug: 125/25 mcg once-daily GSK573719/GW642444
  • Drug: 125mcg once-daily GSK573719
  • Drug: Placebo once-daily
    • Enrollment:
    563
    Primary completion date:
    2012-21-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    umeclidinium bromide, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    January 2011 to July 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40 - 120 years
    Accepts healthy volunteers
    No
    • outpatient
    • signed and dated written informed consent
    • Pregant or lactating women or women planning to become pregnant during the study
    • current diagnosis of asthma
    Inclusion and exclusion criteria
    Inclusion criteria:
    • outpatient
    • signed and dated written informed consent
    • 40 years of age or older
    • male and female subjects
    • COPD diagnosis
    • at least 10 pack-year smoking history
    • post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1 greater than or equal to 35% and less than or equal to 80% of predicted normal
    Exclusion criteria:
    • Pregant or lactating women or women planning to become pregnant during the study
    • current diagnosis of asthma
    • other respiratory disorders other than COPD
    • other diseases/abnormalities that are uncontrolled including cancer not in remission for at least 5 years
    • chest x-ray or CT scan with clinically significant abnormalities not believed to be due to COPD
    • hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium stearate or medical conditions associated with inhaled anticholinergics
    • hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1
    • lung volume reduction surgery within 12 months prior to Visit 1
    • abnormal and clinically significant ECG at Visit 1
    • abnormal and clinically significant Holter monitor finding at Visit 1
    • significantly abnormal finding from laboratory tests at Visit 1
    • unable to withhold albuterol/salbutamol and/or ipratropium bromide at least 4 hours prior to spirometry at each visit
    • use of depot corticosteroids within 12 weeks of Visit 1
    • use of oral or parenteral corticosteroids within 6 weeks of Visit 1
    • use of anitbiotics for lower respiratory tract infection within 6 weeks of Visit 1
    • use of cytochrome P450 3A4 inhibitors within 6 weeks of Visit 1
    • us of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) products if LABA/ICS therapy is discontinued completely within 30 days of Visit 1
    • use of ICS at a dose of >10000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1
    • initiation or discontinuation of ICS within 30 days of Visit 1
    • use of tiotropium within 14 days of Visit 1
    • use of roflumilast within 14 days of Visit 1
    • use of theophyllines within 48 hours of Visit 1
    • use of oral leukotriene inhibitors within 48 hours prior to Visit 1
    • use of long-acting oral beta-agonists within 48 hours of Visit 1
    • use of short-acting oral beta-agonists within 12 hours of Visit 1
    • use of inhaled long-acting beta-agonists within 48 hours prior to Visit 1
    • use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component
    • use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1
    • use of inhaled short acting beta-agonists within 4 hours of Visit 1
    • use of inhaled short-acting anticholinergics within 4 hours of Visit 1
    • use of inhaled short-acting anticholinergic/short-acting beta2-agonist combination products within 4 hours of Visit 1
    • use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer) of Visit 1
    • long-term oxygen therapy prescribed for >12 hours per day
    • regular use of short-acting bronchodilators
    • use of CPAP or NIPPV
    • participation in the maintenance phase of a pulmonary rehabilitation program
    • known or suspected history of alcohol or drug abluse with 2 years prior to Visit 1
    • anyone affiliated with the investigator site (e.g., investigator, study coordinator, etc.)
    • previous use of GSK573719, GW642444 , GSK573719/GW642444 combination, GSK233705/GW642444 combination, or Fluticasone Furoate/GW642444 combination

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bloemfontein, South Africa, 9301
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Shakhty, Rostov region, Russia, 346510
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pitesti, Romania, 110084
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Corsicana, Texas, United States, 75110
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ivanovo, Russia, 153005
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Durban, South Africa, 4001
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 52 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
    2012-21-07
    Actual study completion date
    2012-21-07

    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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