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
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2012-21-07
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
GSK Investigational Site
Shakhty, Rostov region, Russia, 346510
Status
Study Complete
Location
GSK Investigational Site
Corsicana, Texas, United States, 75110
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23229
Status
Study Complete
Location
GSK Investigational Site
Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Morgantown, West Virginia, United States, 26505
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16508
Status
Study Complete
Location
GSK Investigational Site
Plymouth, Minnesota, United States, 55441
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Talca, Región Metro De Santiago, Chile, 3460001
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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.
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