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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02164513
Registration number
NCT02164513
Ethics application status
Date submitted
12/06/2014
Date registered
16/06/2014
Date last updated
10/10/2018
Titles & IDs
Public title
A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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Scientific title
A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
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Secondary ID [1]
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116855
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - fluticasone furoate (FF)
Treatment: Drugs - vilanterol (VI)
Treatment: Drugs - umeclidinium bromide (UMEC)
Experimental: fluticasone furoate/umeclidinium bromide/vilanterol - Eligible Subjects completing 2-weeks run-in period will receive FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg QD (morning) for a period of 52 weeks via DPI
Experimental: fluticasone furoate/vilanterol - Eligible Subjects completing 2-weeks run-in period will receive FF/VI 100 mcg/25 mcg QD (morning) for a treatment period of 52 weeks via DPI)
Experimental: umeclidinium bromide/vilanterol - Eligible Subjects completing 2-weeks run-in period will receive UMEC/VI 62.5 mcg/25 mcg QD (morning) for a treatment period of 52 weeks via DPI
Treatment: Drugs: fluticasone furoate (FF)
FF will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg and FF/VI 100 mcg/25 mcg
Treatment: Drugs: vilanterol (VI)
VI will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, FF/VI 100 mcg/25 mcg and UMEC/VI 62.5 mcg/25 mcg
Treatment: Drugs: umeclidinium bromide (UMEC)
UMEC will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, and UMEC/VI 62.5 mcg/25 mcg
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI
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Assessment method [1]
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The annual rate of moderate or severe COPD exacerbations which occurred during treatment was assessed. Moderate exacerbations were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. Analysis performed using a generalized linear model assuming a negative binomial distribution. ITT population was used which comprised of all randomized participants, excluding those who were randomized in error. Only those participants with non-missing co-variates were included in the analysis.
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Timepoint [1]
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Up to Week 52
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Secondary outcome [1]
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1), at Week 52 Comparing FF/UMEC/VI With FF/VI
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Assessment method [1]
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FEV1 was defined as the amount of air a person exhales in one second. Change from Baseline was calculated as the value of FEV1 at Week 52 minus the value at Baseline. Baseline for trough FEV1 was defined as Day 1 (Pre-dose). Only those participants with non-missing co-variates were included in the analysis. The analysis was performed using a Repeated measures model with covariates of treatment group, smoking status (Screening), geographical region, visit, Baseline, Baseline by visit and treatment group by visit interactions.
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Timepoint [1]
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Baseline and Week 52
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Secondary outcome [2]
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Change From Baseline in St. George's Respiratory Questionnaire for (SGRQ) Total Score at Week 52 Comparing FF/UMEC/VI With FF/VI
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Assessment method [2]
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SGRQ is a disease specific-questionnaire, designed to measure impact of respiratory disease and its treatment on a COPD participant's Health Related Quality of Life (HRQoL). SGRQ contains 14 questions with total of 40 items grouped into three domains (Symptoms, Activity, and Impacts). The overall summary score along with scores for the individual domains of symptoms, activity and impacts were assessed. Score was calculated by summing the pre-assigned weights of answers, dividing by sum of maximum weights for items in SGRQ. Total scores ranged from 0 to 100. A decrease in score indicates improvement in HRQoL and higher score implies worse quality of life. Change from Baseline was calculated as total score at Week 52 minus value at Baseline. Baseline was defined as Day 1. Minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Only those participants with non-missing co-variates were included in the analysis.
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Timepoint [2]
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Baseline and Week 52
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Secondary outcome [3]
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Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With FF/VI and With UMEC/VI
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Assessment method [3]
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This measures the number of days, to the first onset of moderate or severe exacerbations. Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations, were defined as exacerbations that required hospitalization or resulted in death. The Hazard ratio from Cox proportional hazards model with covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted FEV1 (Screening), have been reported. Only those participants with non-missing co-variates were included in the analysis. First quartile and median time to onset are taken from the Kaplan-Meier estimates. If \<25% (and \<50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.
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Timepoint [3]
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Up to Week 52
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Secondary outcome [4]
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Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI in the Subset of Participants With a Blood Eosinophil Count >=150 Cells Per Microliter
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Assessment method [4]
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The annual rate of moderate or severe COPD exacerbations during the treatment, for participants with blood eosinophil count \>=150 cells per microliter , has been reported. Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. Only those participants with non-missing co-variates and non-missing eosinophil, at Baseline were included in the analysis.
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Timepoint [4]
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Up to Week 52
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Secondary outcome [5]
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Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With UMEC/VI in the Subset of Particpants With a Blood Eosinophil Count >=150 Cells Per Microliter at Baseline
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Assessment method [5]
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This measures the number of days, to the first onset of moderate or severe exacerbations for participants with blood eosinophil count \>=150 cells per microliter, at Baseline has been reported. Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations, were defined as exacerbations that required hospitalization or resulted in death. Only those participants with non-missing co-variates and non missing eosinophils at Baseline were included in the analysis. First quartile and median time to onset are taken from the Kaplan-Meier estimates. If \<25% (and \<50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.
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Timepoint [5]
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Up to Week 52
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Secondary outcome [6]
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Annual Rate of On-treatment Severe Exacerbations Comparing FF/UMEC/VI With FF/VI and With UMEC/VI
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Assessment method [6]
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The annual rate of severe COPD exacerbations during the treatment, has been reported. Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. The covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted FEV1 (Screening) were used. Only those participants with non-missing co-variates were included in the analysis
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Timepoint [6]
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Up to Week 52
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Eligibility
Key inclusion criteria
* Informed Consent: A signed and dated written informed consent prior to study participation
* Type of subject: Outpatient
* Age: Subjects 40 years of age or older at Visit 1
* Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to safety follow-up contact): Abstinence; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS); Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
* COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
* Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at screening (visit 1) [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history
* Severity of COPD symptoms: A score of >=10 on the COPD Assessment Test (CAT) at screening
* Severity of COPD Disease: A post-albuterol/salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of <0.70 at Screening
* Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Note: Subjects receiving only Pro re nata (PRN) COPD medications are not eligible
* History of Exacerbations: Subjects must demonstrate: a post-bronchodilator FEV1 <50% predicted normal and a documented history of >= 1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator 50% <=FEV1 < 80% predicted normal and a documented history of >= 2 moderate exacerbations or a documented history of >=1 severe COPD exacerbation (hospitalized) in the previous 12 months. Note: Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations. Note: A documented history of a COPD exacerbation (e.g., medical record verification) is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or hospitalization (for a severe exacerbation). Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable
* Liver function tests: alanine aminotransferase (ALT) <2x upper limit of normal (ULN); alkaline phosphatase <=1.5xULN; bilirubin <=1.5xULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
* French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
* Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
* Alpha1-antitrypsin deficiency: Subjects with Alpha1-antitrypsin deficiency as the underlying cause of COPD
* Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
* Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening
* Risk Factors for Pneumonia: immune suppression (e.g. human immunodeficiency virus [HIV], Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Patients at potentially high risk (e.g. very low BMI, severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator
* Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded
* Other Respiratory tract infections that have not resolved at least 7 days prior to screening
* Abnormal Chest x-ray(CXR): Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest x-ray at Screening Visit 1 (or historical radiograph or computerised tomography (CT) scan obtained within 3 months prior to screening) that will be over-read by a central vendor. Note: Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbation within 3 months of screening must provide a post pneumonia/exacerbation chest x-ray to be over-read by the central vendor or have a chest x-ray conducted at screening. For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz [BfS])
* Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
* Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria
* Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV Heart failure
* Abnormal and clinically significant 12-Lead Electrocardiogram (ECG) finding: Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The Principal Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: atrial fibrillation (AF) with rapid ventricular rate >120 beats per minute); sustained or nonsustained ventricular tachycardia (VT); Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted); QT interval corrected for heart rate (QTcF) >=500 milliseconds (msec) in patients with QRS <120 msec and QTcF >=530 msec in patients with QRS >=120 msec
* Contraindications: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the Investigator contraindicates study participation
* Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment
* Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3 Liter/minute (L/min) (Oxygen use =<3L/min flow is not exclusionary)
* Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol for the 4-hour period required prior to spirometry testing at each study visit
* Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded
* Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
* Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits
* Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
* Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or study site, or immediate family members of the aforementioned that is involved with this study
* Inability to read: In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete study related materials
* Medication prior to screening: Use of the following medications within the following time intervals prior to Screening (Visit 1) or during the study: Long term antibiotic therapy Subjects receiving antibiotics for long term therapy are not eligible for the study (Antibiotics are allowed for the short term treatment of an exacerbation or for short term treatment of other acute infections during the study); Systemic, Oral, parenteral corticosteroids 30 days (Except during the study oral/systemic corticosteroids may be used to treat COPD exacerbations/pneumonia) Intra-articular injections are allowed; Any other investigational drug (30 days or 5 half lives whichever is longer)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/06/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/07/2017
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Sample size
Target
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Accrual to date
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Final
10355
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Concord
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2139 - Concord
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2250 - Gosford
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2035 - Maroubra
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2145 - Westmead
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4870 - Cairns
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4152 - Carina Heights
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5000 - Adelaide
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5041 - Daw Park
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3168 - Clayton
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3011 - Footscray
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3199 - Frankston
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3220 - Geelong
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3300 - Hamilton
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6964 - Murdoch
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6009 - Nedlands
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2107 - Liverpool
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0
0
United States of America
Query!
State/province [30]
0
0
Oregon
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Pennsylvania
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Rhode Island
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
South Carolina
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
South Dakota
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Tennessee
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Texas
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Virginia
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
Washington
Query!
Country [39]
0
0
Argentina
Query!
State/province [39]
0
0
Buenos Aires
Query!
Country [40]
0
0
Argentina
Query!
State/province [40]
0
0
Córdova
Query!
Country [41]
0
0
Argentina
Query!
State/province [41]
0
0
Entre Ríos
Query!
Country [42]
0
0
Argentina
Query!
State/province [42]
0
0
Mendoza
Query!
Country [43]
0
0
Argentina
Query!
State/province [43]
0
0
Santa Fe
Query!
Country [44]
0
0
Argentina
Query!
State/province [44]
0
0
Tucumán
Query!
Country [45]
0
0
Argentina
Query!
State/province [45]
0
0
Berazategui, Buenos Aires
Query!
Country [46]
0
0
Argentina
Query!
State/province [46]
0
0
Berazategui
Query!
Country [47]
0
0
Argentina
Query!
State/province [47]
0
0
Capital Federal
Query!
Country [48]
0
0
Argentina
Query!
State/province [48]
0
0
Ciudad Autonoma de Buenis Aires
Query!
Country [49]
0
0
Argentina
Query!
State/province [49]
0
0
Ciudad Autónoma de Buenos Aires
Query!
Country [50]
0
0
Argentina
Query!
State/province [50]
0
0
Cordoba
Query!
Country [51]
0
0
Argentina
Query!
State/province [51]
0
0
Coronel Suarez
Query!
Country [52]
0
0
Argentina
Query!
State/province [52]
0
0
Monte Grande
Query!
Country [53]
0
0
Argentina
Query!
State/province [53]
0
0
Salta
Query!
Country [54]
0
0
Argentina
Query!
State/province [54]
0
0
San Miguel de Tucumán
Query!
Country [55]
0
0
Argentina
Query!
State/province [55]
0
0
Santa Rosa
Query!
Country [56]
0
0
Austria
Query!
State/province [56]
0
0
Feldbach
Query!
Country [57]
0
0
Austria
Query!
State/province [57]
0
0
Feldkirch
Query!
Country [58]
0
0
Austria
Query!
State/province [58]
0
0
Grieskirchen
Query!
Country [59]
0
0
Austria
Query!
State/province [59]
0
0
Thalheim bei Wels
Query!
Country [60]
0
0
Austria
Query!
State/province [60]
0
0
Vienna
Query!
Country [61]
0
0
Belgium
Query!
State/province [61]
0
0
Antwerpen
Query!
Country [62]
0
0
Belgium
Query!
State/province [62]
0
0
Brugge
Query!
Country [63]
0
0
Belgium
Query!
State/province [63]
0
0
Brussels
Query!
Country [64]
0
0
Belgium
Query!
State/province [64]
0
0
Erpent
Query!
Country [65]
0
0
Belgium
Query!
State/province [65]
0
0
Genk
Query!
Country [66]
0
0
Belgium
Query!
State/province [66]
0
0
Gent
Query!
Country [67]
0
0
Belgium
Query!
State/province [67]
0
0
Gilly
Query!
Country [68]
0
0
Belgium
Query!
State/province [68]
0
0
Hasselt
Query!
Country [69]
0
0
Belgium
Query!
State/province [69]
0
0
Liège
Query!
Country [70]
0
0
Belgium
Query!
State/province [70]
0
0
Malmedy
Query!
Country [71]
0
0
Belgium
Query!
State/province [71]
0
0
Mechelen
Query!
Country [72]
0
0
Belgium
Query!
State/province [72]
0
0
Montigny-Le-Tilleul
Query!
Country [73]
0
0
Belgium
Query!
State/province [73]
0
0
Oostende
Query!
Country [74]
0
0
Belgium
Query!
State/province [74]
0
0
Roeselaere
Query!
Country [75]
0
0
Belgium
Query!
State/province [75]
0
0
Turnhout
Query!
Country [76]
0
0
Brazil
Query!
State/province [76]
0
0
Pernambuco
Query!
Country [77]
0
0
Brazil
Query!
State/province [77]
0
0
Rio Grande Do Sul
Query!
Country [78]
0
0
Brazil
Query!
State/province [78]
0
0
Santa Catarina
Query!
Country [79]
0
0
Brazil
Query!
State/province [79]
0
0
Rio de Janeiro
Query!
Country [80]
0
0
Brazil
Query!
State/province [80]
0
0
São Paulo
Query!
Country [81]
0
0
Canada
Query!
State/province [81]
0
0
Alberta
Query!
Country [82]
0
0
Canada
Query!
State/province [82]
0
0
Manitoba
Query!
Country [83]
0
0
Canada
Query!
State/province [83]
0
0
New Brunswick
Query!
Country [84]
0
0
Canada
Query!
State/province [84]
0
0
Nova Scotia
Query!
Country [85]
0
0
Canada
Query!
State/province [85]
0
0
Ontario
Query!
Country [86]
0
0
Canada
Query!
State/province [86]
0
0
Quebec
Query!
Country [87]
0
0
Chile
Query!
State/province [87]
0
0
Región Del Biobio
Query!
Country [88]
0
0
Chile
Query!
State/province [88]
0
0
Región Del Maule
Query!
Country [89]
0
0
Chile
Query!
State/province [89]
0
0
Región Metro De Santiago
Query!
Country [90]
0
0
Chile
Query!
State/province [90]
0
0
Valparaíso
Query!
Country [91]
0
0
Chile
Query!
State/province [91]
0
0
Santiago
Query!
Country [92]
0
0
Chile
Query!
State/province [92]
0
0
Talcahuano
Query!
Country [93]
0
0
Chile
Query!
State/province [93]
0
0
Viña del Mar
Query!
Country [94]
0
0
China
Query!
State/province [94]
0
0
Guangdong
Query!
Country [95]
0
0
China
Query!
State/province [95]
0
0
Guangxi
Query!
Country [96]
0
0
China
Query!
State/province [96]
0
0
Hainan
Query!
Country [97]
0
0
China
Query!
State/province [97]
0
0
Hebei
Query!
Country [98]
0
0
China
Query!
State/province [98]
0
0
Jiangsu
Query!
Country [99]
0
0
China
Query!
State/province [99]
0
0
Jiangxi
Query!
Country [100]
0
0
China
Query!
State/province [100]
0
0
Jilin
Query!
Country [101]
0
0
China
Query!
State/province [101]
0
0
Liaoning
Query!
Country [102]
0
0
China
Query!
State/province [102]
0
0
Ningxia
Query!
Country [103]
0
0
China
Query!
State/province [103]
0
0
Shandong
Query!
Country [104]
0
0
China
Query!
State/province [104]
0
0
Shanxi
Query!
Country [105]
0
0
China
Query!
State/province [105]
0
0
Sichuan
Query!
Country [106]
0
0
China
Query!
State/province [106]
0
0
Zhejiang
Query!
Country [107]
0
0
China
Query!
State/province [107]
0
0
Beijing
Query!
Country [108]
0
0
China
Query!
State/province [108]
0
0
Changsha
Query!
Country [109]
0
0
China
Query!
State/province [109]
0
0
Chongqing
Query!
Country [110]
0
0
China
Query!
State/province [110]
0
0
Fuzhou
Query!
Country [111]
0
0
China
Query!
State/province [111]
0
0
Guangzhou
Query!
Country [112]
0
0
China
Query!
State/province [112]
0
0
Nanchang
Query!
Country [113]
0
0
China
Query!
State/province [113]
0
0
Shanghai
Query!
Country [114]
0
0
China
Query!
State/province [114]
0
0
Tianjin
Query!
Country [115]
0
0
China
Query!
State/province [115]
0
0
Wuxi
Query!
Country [116]
0
0
Colombia
Query!
State/province [116]
0
0
Barranquilla
Query!
Country [117]
0
0
Colombia
Query!
State/province [117]
0
0
Bogota
Query!
Country [118]
0
0
Colombia
Query!
State/province [118]
0
0
Bogotá
Query!
Country [119]
0
0
Colombia
Query!
State/province [119]
0
0
Medellin
Query!
Country [120]
0
0
Czechia
Query!
State/province [120]
0
0
Benesov
Query!
Country [121]
0
0
Czechia
Query!
State/province [121]
0
0
Brandys nad Labem
Query!
Country [122]
0
0
Czechia
Query!
State/province [122]
0
0
Cvikov
Query!
Country [123]
0
0
Czechia
Query!
State/province [123]
0
0
Holesov
Query!
Country [124]
0
0
Czechia
Query!
State/province [124]
0
0
Hradec Kralove
Query!
Country [125]
0
0
Czechia
Query!
State/province [125]
0
0
Jaromer
Query!
Country [126]
0
0
Czechia
Query!
State/province [126]
0
0
Olomouc
Query!
Country [127]
0
0
Czechia
Query!
State/province [127]
0
0
Ostrava - Poruba
Query!
Country [128]
0
0
Czechia
Query!
State/province [128]
0
0
Plzen
Query!
Country [129]
0
0
Czechia
Query!
State/province [129]
0
0
Praha 5
Query!
Country [130]
0
0
Czechia
Query!
State/province [130]
0
0
Praha 8
Query!
Country [131]
0
0
Czechia
Query!
State/province [131]
0
0
Tabor
Query!
Country [132]
0
0
Czechia
Query!
State/province [132]
0
0
Teplice
Query!
Country [133]
0
0
Czechia
Query!
State/province [133]
0
0
Trebic
Query!
Country [134]
0
0
Denmark
Query!
State/province [134]
0
0
Aalborg
Query!
Country [135]
0
0
Denmark
Query!
State/province [135]
0
0
Aarhus C
Query!
Country [136]
0
0
Denmark
Query!
State/province [136]
0
0
Hellerup
Query!
Country [137]
0
0
Denmark
Query!
State/province [137]
0
0
Hvidovre
Query!
Country [138]
0
0
Denmark
Query!
State/province [138]
0
0
Kolding
Query!
Country [139]
0
0
Denmark
Query!
State/province [139]
0
0
Odense C
Query!
Country [140]
0
0
Denmark
Query!
State/province [140]
0
0
Roskilde
Query!
Country [141]
0
0
Denmark
Query!
State/province [141]
0
0
Sønderborg
Query!
Country [142]
0
0
Finland
Query!
State/province [142]
0
0
Espoo
Query!
Country [143]
0
0
Finland
Query!
State/province [143]
0
0
Helsinki
Query!
Country [144]
0
0
Finland
Query!
State/province [144]
0
0
Jyvaskyla
Query!
Country [145]
0
0
Finland
Query!
State/province [145]
0
0
Lohja
Query!
Country [146]
0
0
Finland
Query!
State/province [146]
0
0
Tampere
Query!
Country [147]
0
0
Finland
Query!
State/province [147]
0
0
Turku
Query!
Country [148]
0
0
France
Query!
State/province [148]
0
0
Bayonne cedex
Query!
Country [149]
0
0
France
Query!
State/province [149]
0
0
Brest Cedex
Query!
Country [150]
0
0
France
Query!
State/province [150]
0
0
Briis-sous-Forge
Query!
Country [151]
0
0
France
Query!
State/province [151]
0
0
Grenoble cedex 9
Query!
Country [152]
0
0
France
Query!
State/province [152]
0
0
Le Mans
Query!
Country [153]
0
0
France
Query!
State/province [153]
0
0
Lyon cedex 04
Query!
Country [154]
0
0
France
Query!
State/province [154]
0
0
Marseille cedex 03
Query!
Country [155]
0
0
France
Query!
State/province [155]
0
0
Montauban cedex
Query!
Country [156]
0
0
France
Query!
State/province [156]
0
0
Montpellier cedex 5
Query!
Country [157]
0
0
France
Query!
State/province [157]
0
0
Nimes
Query!
Country [158]
0
0
France
Query!
State/province [158]
0
0
Orléans cedex 2
Query!
Country [159]
0
0
France
Query!
State/province [159]
0
0
Paris
Query!
Country [160]
0
0
France
Query!
State/province [160]
0
0
Perpignan
Query!
Country [161]
0
0
France
Query!
State/province [161]
0
0
Pessac cedex
Query!
Country [162]
0
0
France
Query!
State/province [162]
0
0
Pringy cedex
Query!
Country [163]
0
0
France
Query!
State/province [163]
0
0
Rennes Cedex 9
Query!
Country [164]
0
0
France
Query!
State/province [164]
0
0
Strasbourg cedex
Query!
Country [165]
0
0
France
Query!
State/province [165]
0
0
Toulon
Query!
Country [166]
0
0
France
Query!
State/province [166]
0
0
Vandoeuvre-les-Nancy
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Baden-Wuerttemberg
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Bayern
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Brandenburg
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Hessen
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Niedersachsen
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Nordrhein-Westfalen
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Rheinland-Pfalz
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Saarland
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Sachsen-Anhalt
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Sachsen
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Schleswig-Holstein
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Thueringen
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Berlin
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Deggendorf
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Hamburg
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Witten
Query!
Country [183]
0
0
Hong Kong
Query!
State/province [183]
0
0
Kwun Tong
Query!
Country [184]
0
0
Hong Kong
Query!
State/province [184]
0
0
Lai Chi Kok
Query!
Country [185]
0
0
Hong Kong
Query!
State/province [185]
0
0
Pokfulam
Query!
Country [186]
0
0
Hong Kong
Query!
State/province [186]
0
0
Shatin
Query!
Country [187]
0
0
Hong Kong
Query!
State/province [187]
0
0
Tuen Mun
Query!
Country [188]
0
0
Israel
Query!
State/province [188]
0
0
Afula
Query!
Country [189]
0
0
Israel
Query!
State/province [189]
0
0
Ashkelon
Query!
Country [190]
0
0
Israel
Query!
State/province [190]
0
0
Haifa
Query!
Country [191]
0
0
Israel
Query!
State/province [191]
0
0
Holon
Query!
Country [192]
0
0
Israel
Query!
State/province [192]
0
0
Jerusalem
Query!
Country [193]
0
0
Israel
Query!
State/province [193]
0
0
Kfar-Saba
Query!
Country [194]
0
0
Israel
Query!
State/province [194]
0
0
Petah Tikva
Query!
Country [195]
0
0
Israel
Query!
State/province [195]
0
0
Ramat Gan
Query!
Country [196]
0
0
Israel
Query!
State/province [196]
0
0
Rehovot
Query!
Country [197]
0
0
Israel
Query!
State/province [197]
0
0
Tel Aviv
Query!
Country [198]
0
0
Israel
Query!
State/province [198]
0
0
Tel-Aviv
Query!
Country [199]
0
0
Israel
Query!
State/province [199]
0
0
Zrifin
Query!
Country [200]
0
0
Japan
Query!
State/province [200]
0
0
Aichi
Query!
Country [201]
0
0
Japan
Query!
State/province [201]
0
0
Chiba
Query!
Country [202]
0
0
Japan
Query!
State/province [202]
0
0
Ehime
Query!
Country [203]
0
0
Japan
Query!
State/province [203]
0
0
Fukuoka
Query!
Country [204]
0
0
Japan
Query!
State/province [204]
0
0
Gifu
Query!
Country [205]
0
0
Japan
Query!
State/province [205]
0
0
Gunma
Query!
Country [206]
0
0
Japan
Query!
State/province [206]
0
0
Hiroshima
Query!
Country [207]
0
0
Japan
Query!
State/province [207]
0
0
Hokkaido
Query!
Country [208]
0
0
Japan
Query!
State/province [208]
0
0
Hyogo
Query!
Country [209]
0
0
Japan
Query!
State/province [209]
0
0
Ibaraki
Query!
Country [210]
0
0
Japan
Query!
State/province [210]
0
0
Ishikawa
Query!
Country [211]
0
0
Japan
Query!
State/province [211]
0
0
Iwate
Query!
Country [212]
0
0
Japan
Query!
State/province [212]
0
0
Kagawa
Query!
Country [213]
0
0
Japan
Query!
State/province [213]
0
0
Kanagawa
Query!
Country [214]
0
0
Japan
Query!
State/province [214]
0
0
Kochi
Query!
Country [215]
0
0
Japan
Query!
State/province [215]
0
0
Kumamoto
Query!
Country [216]
0
0
Japan
Query!
State/province [216]
0
0
Kyoto
Query!
Country [217]
0
0
Japan
Query!
State/province [217]
0
0
Mie
Query!
Country [218]
0
0
Japan
Query!
State/province [218]
0
0
Miyagi
Query!
Country [219]
0
0
Japan
Query!
State/province [219]
0
0
Nagano
Query!
Country [220]
0
0
Japan
Query!
State/province [220]
0
0
Niigata
Query!
Country [221]
0
0
Japan
Query!
State/province [221]
0
0
Oita
Query!
Country [222]
0
0
Japan
Query!
State/province [222]
0
0
Okayama
Query!
Country [223]
0
0
Japan
Query!
State/province [223]
0
0
Okinawa
Query!
Country [224]
0
0
Japan
Query!
State/province [224]
0
0
Osaka
Query!
Country [225]
0
0
Japan
Query!
State/province [225]
0
0
Saitama
Query!
Country [226]
0
0
Japan
Query!
State/province [226]
0
0
Shizuoka
Query!
Country [227]
0
0
Japan
Query!
State/province [227]
0
0
Tochigi
Query!
Country [228]
0
0
Japan
Query!
State/province [228]
0
0
Tokyo
Query!
Country [229]
0
0
Japan
Query!
State/province [229]
0
0
Toyama
Query!
Country [230]
0
0
Japan
Query!
State/province [230]
0
0
Wakayama
Query!
Country [231]
0
0
Japan
Query!
State/province [231]
0
0
Yamagata
Query!
Country [232]
0
0
Japan
Query!
State/province [232]
0
0
Yamanashi
Query!
Country [233]
0
0
Korea, Republic of
Query!
State/province [233]
0
0
Bucheon city, Gyenggi-do
Query!
Country [234]
0
0
Korea, Republic of
Query!
State/province [234]
0
0
Cheongju-si, Chungcheongbuk-do
Query!
Country [235]
0
0
Korea, Republic of
Query!
State/province [235]
0
0
Gyeonggi-do
Query!
Country [236]
0
0
Korea, Republic of
Query!
State/province [236]
0
0
Incheon
Query!
Country [237]
0
0
Korea, Republic of
Query!
State/province [237]
0
0
Jeonju-si
Query!
Country [238]
0
0
Korea, Republic of
Query!
State/province [238]
0
0
Kangwon-do
Query!
Country [239]
0
0
Korea, Republic of
Query!
State/province [239]
0
0
Seoul
Query!
Country [240]
0
0
Korea, Republic of
Query!
State/province [240]
0
0
Suwon
Query!
Country [241]
0
0
Netherlands
Query!
State/province [241]
0
0
Alkmaar
Query!
Country [242]
0
0
Netherlands
Query!
State/province [242]
0
0
Almelo
Query!
Country [243]
0
0
Netherlands
Query!
State/province [243]
0
0
Assen
Query!
Country [244]
0
0
Netherlands
Query!
State/province [244]
0
0
Beek
Query!
Country [245]
0
0
Netherlands
Query!
State/province [245]
0
0
Breda
Query!
Country [246]
0
0
Netherlands
Query!
State/province [246]
0
0
Den Bosch
Query!
Country [247]
0
0
Netherlands
Query!
State/province [247]
0
0
Dordrecht
Query!
Country [248]
0
0
Netherlands
Query!
State/province [248]
0
0
Eindhoven
Query!
Country [249]
0
0
Netherlands
Query!
State/province [249]
0
0
Enschede
Query!
Country [250]
0
0
Netherlands
Query!
State/province [250]
0
0
Groningen
Query!
Country [251]
0
0
Netherlands
Query!
State/province [251]
0
0
Harderwijk
Query!
Country [252]
0
0
Netherlands
Query!
State/province [252]
0
0
Helmond
Query!
Country [253]
0
0
Netherlands
Query!
State/province [253]
0
0
Hoofddorp
Query!
Country [254]
0
0
Netherlands
Query!
State/province [254]
0
0
Hoorn
Query!
Country [255]
0
0
Netherlands
Query!
State/province [255]
0
0
Kloosterhaar
Query!
Country [256]
0
0
Netherlands
Query!
State/province [256]
0
0
Leeuwarden
Query!
Country [257]
0
0
Netherlands
Query!
State/province [257]
0
0
Nieuwegein
Query!
Country [258]
0
0
Netherlands
Query!
State/province [258]
0
0
Rotterdam
Query!
Country [259]
0
0
Netherlands
Query!
State/province [259]
0
0
Sneek
Query!
Country [260]
0
0
Netherlands
Query!
State/province [260]
0
0
Spijkenisse
Query!
Country [261]
0
0
Netherlands
Query!
State/province [261]
0
0
Veldhoven
Query!
Country [262]
0
0
Netherlands
Query!
State/province [262]
0
0
Zutphen
Query!
Country [263]
0
0
Netherlands
Query!
State/province [263]
0
0
Zwolle
Query!
Country [264]
0
0
New Zealand
Query!
State/province [264]
0
0
Auckland
Query!
Country [265]
0
0
New Zealand
Query!
State/province [265]
0
0
Dunedin
Query!
Country [266]
0
0
New Zealand
Query!
State/province [266]
0
0
Newtown, Wellington
Query!
Country [267]
0
0
New Zealand
Query!
State/province [267]
0
0
Tauranga
Query!
Country [268]
0
0
New Zealand
Query!
State/province [268]
0
0
Wellington
Query!
Country [269]
0
0
Norway
Query!
State/province [269]
0
0
Bodø
Query!
Country [270]
0
0
Norway
Query!
State/province [270]
0
0
Fredrikstad
Query!
Country [271]
0
0
Norway
Query!
State/province [271]
0
0
Hakadal
Query!
Country [272]
0
0
Norway
Query!
State/province [272]
0
0
Kløfta
Query!
Country [273]
0
0
Norway
Query!
State/province [273]
0
0
Levanger
Query!
Country [274]
0
0
Norway
Query!
State/province [274]
0
0
Oslo
Query!
Country [275]
0
0
Norway
Query!
State/province [275]
0
0
Stavanger
Query!
Country [276]
0
0
Norway
Query!
State/province [276]
0
0
Trondheim
Query!
Country [277]
0
0
Peru
Query!
State/province [277]
0
0
Lima
Query!
Country [278]
0
0
Philippines
Query!
State/province [278]
0
0
Caloocan City
Query!
Country [279]
0
0
Philippines
Query!
State/province [279]
0
0
Iloilo
Query!
Country [280]
0
0
Philippines
Query!
State/province [280]
0
0
Jaro, Iloilo City
Query!
Country [281]
0
0
Philippines
Query!
State/province [281]
0
0
Pasig
Query!
Country [282]
0
0
Philippines
Query!
State/province [282]
0
0
Quezon City
Query!
Country [283]
0
0
Poland
Query!
State/province [283]
0
0
Bialystok
Query!
Country [284]
0
0
Poland
Query!
State/province [284]
0
0
Ostrowiec Swietokrzyski
Query!
Country [285]
0
0
Poland
Query!
State/province [285]
0
0
Sopot
Query!
Country [286]
0
0
Poland
Query!
State/province [286]
0
0
Szczecin
Query!
Country [287]
0
0
Poland
Query!
State/province [287]
0
0
Tarnów
Query!
Country [288]
0
0
Poland
Query!
State/province [288]
0
0
Zgierz
Query!
Country [289]
0
0
Puerto Rico
Query!
State/province [289]
0
0
Guaynabo
Query!
Country [290]
0
0
Puerto Rico
Query!
State/province [290]
0
0
Mayaguez
Query!
Country [291]
0
0
Puerto Rico
Query!
State/province [291]
0
0
Ponce
Query!
Country [292]
0
0
Puerto Rico
Query!
State/province [292]
0
0
San Juan
Query!
Country [293]
0
0
Romania
Query!
State/province [293]
0
0
Braila
Query!
Country [294]
0
0
Romania
Query!
State/province [294]
0
0
Brasov
Query!
Country [295]
0
0
Romania
Query!
State/province [295]
0
0
Bucharest
Query!
Country [296]
0
0
Romania
Query!
State/province [296]
0
0
Comuna Alexandru Cel Bun
Query!
Country [297]
0
0
Romania
Query!
State/province [297]
0
0
Constanta
Query!
Country [298]
0
0
Romania
Query!
State/province [298]
0
0
Ploiesti
Query!
Country [299]
0
0
Romania
Query!
State/province [299]
0
0
Ramnicu Valcea
Query!
Country [300]
0
0
Russian Federation
Query!
State/province [300]
0
0
Barnaul
Query!
Country [301]
0
0
Russian Federation
Query!
State/province [301]
0
0
Belgorod
Query!
Country [302]
0
0
Russian Federation
Query!
State/province [302]
0
0
Blagoveshchensk
Query!
Country [303]
0
0
Russian Federation
Query!
State/province [303]
0
0
Chita
Query!
Country [304]
0
0
Russian Federation
Query!
State/province [304]
0
0
Ekaterinburg
Query!
Country [305]
0
0
Russian Federation
Query!
State/province [305]
0
0
Ivanovo
Query!
Country [306]
0
0
Russian Federation
Query!
State/province [306]
0
0
Kazan
Query!
Country [307]
0
0
Russian Federation
Query!
State/province [307]
0
0
Krasnodar
Query!
Country [308]
0
0
Russian Federation
Query!
State/province [308]
0
0
Krasnoyarsk
Query!
Country [309]
0
0
Russian Federation
Query!
State/province [309]
0
0
Moscow
Query!
Country [310]
0
0
Russian Federation
Query!
State/province [310]
0
0
Novgorod
Query!
Country [311]
0
0
Russian Federation
Query!
State/province [311]
0
0
Novosibirsk
Query!
Country [312]
0
0
Russian Federation
Query!
State/province [312]
0
0
Petrozavodsk
Query!
Country [313]
0
0
Russian Federation
Query!
State/province [313]
0
0
Pyatigorsk
Query!
Country [314]
0
0
Russian Federation
Query!
State/province [314]
0
0
Ryazan
Query!
Country [315]
0
0
Russian Federation
Query!
State/province [315]
0
0
Saint-Petersburg
Query!
Country [316]
0
0
Russian Federation
Query!
State/province [316]
0
0
Saratov
Query!
Country [317]
0
0
Russian Federation
Query!
State/province [317]
0
0
St. Petersburg
Query!
Country [318]
0
0
Russian Federation
Query!
State/province [318]
0
0
Stavropol
Query!
Country [319]
0
0
Russian Federation
Query!
State/province [319]
0
0
Tomsk
Query!
Country [320]
0
0
Russian Federation
Query!
State/province [320]
0
0
Ulan-Ude
Query!
Country [321]
0
0
Russian Federation
Query!
State/province [321]
0
0
Ulyanovsk
Query!
Country [322]
0
0
Russian Federation
Query!
State/province [322]
0
0
Vladimir
Query!
Country [323]
0
0
Russian Federation
Query!
State/province [323]
0
0
Vladivostok
Query!
Country [324]
0
0
Russian Federation
Query!
State/province [324]
0
0
Volgodonsk
Query!
Country [325]
0
0
Russian Federation
Query!
State/province [325]
0
0
Voronezh
Query!
Country [326]
0
0
Russian Federation
Query!
State/province [326]
0
0
Vsevolozhsk, Leningrad Region
Query!
Country [327]
0
0
Russian Federation
Query!
State/province [327]
0
0
Yaroslavl
Query!
Country [328]
0
0
Singapore
Query!
State/province [328]
0
0
Singapore
Query!
Country [329]
0
0
South Africa
Query!
State/province [329]
0
0
Gauteng
Query!
Country [330]
0
0
South Africa
Query!
State/province [330]
0
0
Mpumalanga
Query!
Country [331]
0
0
South Africa
Query!
State/province [331]
0
0
Amanzimtoti
Query!
Country [332]
0
0
South Africa
Query!
State/province [332]
0
0
Bellville
Query!
Country [333]
0
0
South Africa
Query!
State/province [333]
0
0
Bloemfontein
Query!
Country [334]
0
0
South Africa
Query!
State/province [334]
0
0
Boksburg North
Query!
Country [335]
0
0
South Africa
Query!
State/province [335]
0
0
Cape Town
Query!
Country [336]
0
0
South Africa
Query!
State/province [336]
0
0
CapeTown
Query!
Country [337]
0
0
South Africa
Query!
State/province [337]
0
0
Durban
Query!
Country [338]
0
0
South Africa
Query!
State/province [338]
0
0
Gatesville
Query!
Country [339]
0
0
South Africa
Query!
State/province [339]
0
0
Johannesburg
Query!
Country [340]
0
0
South Africa
Query!
State/province [340]
0
0
Korsten
Query!
Country [341]
0
0
South Africa
Query!
State/province [341]
0
0
Mowbray
Query!
Country [342]
0
0
South Africa
Query!
State/province [342]
0
0
Paarl
Query!
Country [343]
0
0
South Africa
Query!
State/province [343]
0
0
Panorama
Query!
Country [344]
0
0
South Africa
Query!
State/province [344]
0
0
Tygerberg
Query!
Country [345]
0
0
Spain
Query!
State/province [345]
0
0
Andalucia
Query!
Country [346]
0
0
Spain
Query!
State/province [346]
0
0
Cantabria
Query!
Country [347]
0
0
Spain
Query!
State/province [347]
0
0
Catalonia
Query!
Country [348]
0
0
Spain
Query!
State/province [348]
0
0
(Badalona) Barcelona
Query!
Country [349]
0
0
Spain
Query!
State/province [349]
0
0
(Barakaldo) Vizcaya
Query!
Country [350]
0
0
Spain
Query!
State/province [350]
0
0
Alicante
Query!
Country [351]
0
0
Spain
Query!
State/province [351]
0
0
Alzira/Valencia
Query!
Country [352]
0
0
Spain
Query!
State/province [352]
0
0
Barcelona
Query!
Country [353]
0
0
Spain
Query!
State/province [353]
0
0
Basurto/Bilbao
Query!
Country [354]
0
0
Spain
Query!
State/province [354]
0
0
Burgos
Query!
Country [355]
0
0
Spain
Query!
State/province [355]
0
0
Centelles (Barcelona)
Query!
Country [356]
0
0
Spain
Query!
State/province [356]
0
0
Coslada
Query!
Country [357]
0
0
Spain
Query!
State/province [357]
0
0
Cáceres
Query!
Country [358]
0
0
Spain
Query!
State/province [358]
0
0
Gerona
Query!
Country [359]
0
0
Spain
Query!
State/province [359]
0
0
Girona
Query!
Country [360]
0
0
Spain
Query!
State/province [360]
0
0
L'Hospitalet de Llobregat
Query!
Country [361]
0
0
Spain
Query!
State/province [361]
0
0
La Coruña
Query!
Country [362]
0
0
Spain
Query!
State/province [362]
0
0
La Roca Del Valles (Barcelona)
Query!
Country [363]
0
0
Spain
Query!
State/province [363]
0
0
Lleida
Query!
Country [364]
0
0
Spain
Query!
State/province [364]
0
0
Madrid
Query!
Country [365]
0
0
Spain
Query!
State/province [365]
0
0
Mataró
Query!
Country [366]
0
0
Spain
Query!
State/province [366]
0
0
Málaga
Query!
Country [367]
0
0
Spain
Query!
State/province [367]
0
0
Mérida (Badajoz)
Query!
Country [368]
0
0
Spain
Query!
State/province [368]
0
0
Oviedo
Query!
Country [369]
0
0
Spain
Query!
State/province [369]
0
0
Palma de Mallorca
Query!
Country [370]
0
0
Spain
Query!
State/province [370]
0
0
Pamplona
Query!
Country [371]
0
0
Spain
Query!
State/province [371]
0
0
Peralada( Girona)
Query!
Country [372]
0
0
Spain
Query!
State/province [372]
0
0
Petrer/Alicante
Query!
Country [373]
0
0
Spain
Query!
State/province [373]
0
0
Ponferrada (León)
Query!
Country [374]
0
0
Spain
Query!
State/province [374]
0
0
Pozuelo De Alarcón/Madrid
Query!
Country [375]
0
0
Spain
Query!
State/province [375]
0
0
Sabadell (Barcelona)
Query!
Country [376]
0
0
Spain
Query!
State/province [376]
0
0
Sagunto/Valencia
Query!
Country [377]
0
0
Spain
Query!
State/province [377]
0
0
Salamanca
Query!
Country [378]
0
0
Spain
Query!
State/province [378]
0
0
San Juan De Alicante
Query!
Country [379]
0
0
Spain
Query!
State/province [379]
0
0
San Sebastian de los Reyes
Query!
Country [380]
0
0
Spain
Query!
State/province [380]
0
0
Santander
Query!
Country [381]
0
0
Spain
Query!
State/province [381]
0
0
Santiago de Compostela
Query!
Country [382]
0
0
Spain
Query!
State/province [382]
0
0
Sevilla
Query!
Country [383]
0
0
Spain
Query!
State/province [383]
0
0
Tarragona
Query!
Country [384]
0
0
Spain
Query!
State/province [384]
0
0
Valencia
Query!
Country [385]
0
0
Spain
Query!
State/province [385]
0
0
Valladolid
Query!
Country [386]
0
0
Spain
Query!
State/province [386]
0
0
Vizcaya
Query!
Country [387]
0
0
Spain
Query!
State/province [387]
0
0
Zaragoza
Query!
Country [388]
0
0
Sweden
Query!
State/province [388]
0
0
Borås
Query!
Country [389]
0
0
Sweden
Query!
State/province [389]
0
0
Göteborg
Query!
Country [390]
0
0
Sweden
Query!
State/province [390]
0
0
Höllviken
Query!
Country [391]
0
0
Sweden
Query!
State/province [391]
0
0
Linköping
Query!
Country [392]
0
0
Sweden
Query!
State/province [392]
0
0
Luleå
Query!
Country [393]
0
0
Sweden
Query!
State/province [393]
0
0
Stockholm
Query!
Country [394]
0
0
Sweden
Query!
State/province [394]
0
0
Uppsala
Query!
Country [395]
0
0
Sweden
Query!
State/province [395]
0
0
Örebro
Query!
Country [396]
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Summary
Brief summary
The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid \[ICS\]/ Long-acting Muscarinic Receptor Antagonists \[LAMA\])/ Long Acting Beta-Agonist \[LABA\] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year. Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety follow-up period. Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD
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Trial website
https://clinicaltrials.gov/study/NCT02164513
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Trial related presentations / publications
Dransfield MT, Criner GJ, Halpin DMG, Han MK, Hartley B, Kalhan R, Lange P, Lipson DA, Martinez FJ, Midwinter D, Singh D, Wise R, Kunisaki KM. Time-Dependent Risk of Cardiovascular Events Following an Exacerbation in Patients With Chronic Obstructive Pulmonary Disease: Post Hoc Analysis From the IMPACT Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e024350. doi: 10.1161/JAHA.121.024350. Epub 2022 Sep 14. Thomashow B, Stiegler M, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Martinez FJ, Midwinter D, Singh D, Tabberer M, Wise RA, Lipson DA, Jones P. Higher COPD Assessment Test Score Associated With Greater Exacerbations Risk: A Post Hoc Analysis of the IMPACT Trial. Chronic Obstr Pulm Dis. 2022 Jan 27;9(1):68-79. doi: 10.15326/jcopdf.2021.0259. Bafadhel M, Barnes N, Bourke SC, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Jones CE, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Martinez FJ, Wise R, Singh D. A single blood eosinophil count measurement is as good as two for prediction of ICS treatment response in the IMPACT trial. Eur Respir J. 2021 Sep 23;58(3):2004522. doi: 10.1183/13993003.04522-2020. Print 2021 Sep. No abstract available. Singh D, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Lettis S, Lipson DA, Mannino D, Martin N, Martinez FJ, Miller BE, Wise R, Zhu CQ, Lomas D. InforMing the PAthway of COPD Treatment (IMPACT) trial: fibrinogen levels predict risk of moderate or severe exacerbations. Respir Res. 2021 Apr 28;22(1):130. doi: 10.1186/s12931-021-01706-y. Halpin DMG, Criner GJ, Dransfield MT, Han MK, Hartley B, Harvey C, Jones CE, Kato M, Lange P, Lettis S, Lomas DA, Martinez FJ, Martin N, Singh D, Wise R, Zheng J, Lipson DA. Triple Versus Dual Combination Therapy in Chronic Obstructive Pulmonary Disease in Asian Countries: Analysis of the IMPACT Trial. Pulm Ther. 2021 Jun;7(1):101-118. doi: 10.1007/s41030-020-00136-3. Epub 2020 Nov 17. Bourdin A, Criner G, Devouassoux G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kalhan R, Lange P, Lettis S, Lipson DA, Lomas DA, Echave-Sustaeta Maria-Tome JM, Martin N, Martinez FJ, Quasny H, Sail L, Siler TM, Singh D, Thomashow B, Watz H, Wise R, Hanania NA. InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions. Chronic Obstr Pulm Dis. 2021 Jan;8(1):76-90. doi: 10.15326/jcopdf.2020.0158. Zheng J, Zhong N, Wang C, Wei LP, Zhou XD, Zhao L, Dong Yuan Y, He B, Wu B, Du X, Song J, Lipson DA. Single inhaler triple therapy (FF/UMEC/VI) versus FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the China cohort in the IMPACT trial. Curr Med Res Opin. 2021 Jan;37(1):145-155. doi: 10.1080/03007995.2020.1844646. Epub 2020 Dec 7. Marin JM, Mateos L, Roldan J, Echave-Sustaeta JM, Pascual-Guardia S, Pardo MV, Velasco B, Jones CE, Kilbride S, Lipson DA. Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620963021. doi: 10.1177/1753466620963021. Hanania NA, Mannino DM, Criner GJ, Dransfield MT, Han MK, Jones CE, Kilbride S, Lomas DA, Martin N, Martinez FJ, Singh D, Wise RA, Halpin DMG, Lima R, Lipson DA. Effect of Age on the Efficacy and Safety of Once-Daily Single-Inhaler Triple-Therapy Fluticasone Furoate/Umeclidinium/Vilanterol in Patients With COPD: A Post Hoc Analysis of the Informing the Pathway of COPD Treatment Trial. Chest. 2021 Mar;159(3):985-995. doi: 10.1016/j.chest.2020.09.253. Epub 2020 Oct 5. Tabberer M, Jones CE, Kilbride S, Halpin DMG, Lomas DA, Pascoe S, Singh D, Wise RA, Criner GJ, Lange P, Dransfield MT, Han MK, Martinez FJ, Kaisermann MC, Lipson DA. Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study. Adv Ther. 2020 Sep;37(9):3775-3790. doi: 10.1007/s12325-020-01409-8. Epub 2020 Jul 9. Erratum In: Adv Ther. 2022 Mar;39(3):1446. doi: 10.1007/s12325-021-02019-8. Han MK, Criner GJ, Dransfield MT, Halpin DMG, Jones CE, Kilbride S, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Wise RA, Singh D, Martinez FJ. The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial. Am J Respir Crit Care Med. 2020 Nov 1;202(9):1237-1243. doi: 10.1164/rccm.201912-2478OC. Day NC, Kumar S, Criner G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kaisermann MC, Kilbride S, Lange P, Lomas DA, Martin N, Martinez FJ, Singh D, Wise R, Lipson DA. Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial. Respir Res. 2020 Jun 5;21(1):139. doi: 10.1186/s12931-020-01398-w. Bogart MR, Hopson SD, Shih HC, Stanford RH, Coutinho AD. COPD exacerbation costs in the IMPACT study: a within-trial analysis. Am J Manag Care. 2020 May 1;26(5):e150-e154. doi: 10.37765/ajmc.2020.43157. Halpin DMG, Dransfield MT, Han MK, Jones CE, Kilbride S, Lange P, Lipson DA, Lomas DA, Martinez FJ, Pascoe S, Singh D, Wise R, Criner GJ. The effect of exacerbation history on outcomes in the IMPACT trial. Eur Respir J. 2020 May 21;55(5):1901921. doi: 10.1183/13993003.01921-2019. Print 2020 May. Erratum In: Eur Respir J. 2020 Jun 18;55(6):1951921. doi: 10.1183/13993003.51921-2019. Lipson DA, Crim C, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Lettis S, Manchester P, Martin N, Midwinter D, Morris A, Pascoe SJ, Singh D, Wise RA, Martinez FJ. Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1508-1516. doi: 10.1164/rccm.201911-2207OC. Ismaila AS, Risebrough N, Schroeder M, Shah D, Martin A, Goodall EC, Ndirangu K, Criner G, Dransfield M, Halpin DM, Han MK, Lomas DA. Cost-Effectiveness Of Once-Daily Single-Inhaler Triple Therapy In COPD: The IMPACT Trial. Int J Chron Obstruct Pulmon Dis. 2019 Nov 29;14:2681-2695. doi: 10.2147/COPD.S216072. eCollection 2019. Mehta R, Farrell C, Hayes S, Birk R, Okour M, Lipson DA. Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2020 Jan;59(1):67-79. doi: 10.1007/s40262-019-00794-w. Pascoe S, Barnes N, Brusselle G, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Lange P, Lettis S, Lipson DA, Lomas DA, Martinez FJ, Papi A, Roche N, van der Valk RJP, Wise R, Singh D. Blood eosinophils and treatment response with triple and dual combination therapy in chronic obstructive pulmonary disease: analysis of the IMPACT trial. Lancet Respir Med. 2019 Sep;7(9):745-756. doi: 10.1016/S2213-2600(19)30190-0. Epub 2019 Jul 4. Erratum In: Lancet Respir Med. 2021 Dec;9(12):e114. doi: 10.1016/S2213-2600(21)00516-6. Lipson DA, Barnhart F, Brealey N, Brooks J, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Martinez FJ, Singh D, Tabberer M, Wise RA, Pascoe SJ; IMPACT Investigators. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med. 2018 May 3;378(18):1671-1680. doi: 10.1056/NEJMoa1713901. Epub 2018 Apr 18. Pascoe SJ, Lipson DA, Locantore N, Barnacle H, Brealey N, Mohindra R, Dransfield MT, Pavord I, Barnes N. A phase III randomised controlled trial of single-dose triple therapy in COPD: the IMPACT protocol. Eur Respir J. 2016 Aug;48(2):320-30. doi: 10.1183/13993003.02165-2015. Epub 2016 Jul 13.
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GSK Clinical Trials
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/13/NCT02164513/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/13/NCT02164513/SAP_001.pdf
Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT02164513
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