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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)
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
Secondary ID [1] 0 0
116855
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI
Timepoint [1] 0 0
Up to Week 52
Secondary outcome [1] 0 0
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1), at Week 52 Comparing FF/UMEC/VI With FF/VI
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [2] 0 0
Change From Baseline in St. George's Respiratory Questionnaire for (SGRQ) Total Score at Week 52 Comparing FF/UMEC/VI With FF/VI
Timepoint [2] 0 0
Baseline and Week 52
Secondary outcome [3] 0 0
Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With FF/VI and With UMEC/VI
Timepoint [3] 0 0
Up to Week 52
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to Week 52
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Up to Week 52
Secondary outcome [6] 0 0
Annual Rate of On-treatment Severe Exacerbations Comparing FF/UMEC/VI With FF/VI and With UMEC/VI
Timepoint [6] 0 0
Up to Week 52

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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/07/2017
Sample size
Target
Accrual to date
Final
10355
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Concord
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GSK Investigational Site - Gosford
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GSK Investigational Site - Maroubra
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GSK Investigational Site - Westmead
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GSK Investigational Site - Cairns
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GSK Investigational Site - Carina Heights
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GSK Investigational Site - Adelaide
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GSK Investigational Site - Daw Park
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GSK Investigational Site - Clayton
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GSK Investigational Site - Footscray
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GSK Investigational Site - Frankston
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GSK Investigational Site - Geelong
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GSK Investigational Site - Hamilton
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GSK Investigational Site - Murdoch
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GSK Investigational Site - Nedlands
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GSK Investigational Site - Liverpool
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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
Recruitment postcode(s) [16] 0 0
2107 - Liverpool
Recruitment outside Australia
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State/province [110] 0 0
Fuzhou
Country [111] 0 0
China
State/province [111] 0 0
Guangzhou
Country [112] 0 0
China
State/province [112] 0 0
Nanchang
Country [113] 0 0
China
State/province [113] 0 0
Shanghai
Country [114] 0 0
China
State/province [114] 0 0
Tianjin
Country [115] 0 0
China
State/province [115] 0 0
Wuxi
Country [116] 0 0
Colombia
State/province [116] 0 0
Barranquilla
Country [117] 0 0
Colombia
State/province [117] 0 0
Bogota
Country [118] 0 0
Colombia
State/province [118] 0 0
Bogotá
Country [119] 0 0
Colombia
State/province [119] 0 0
Medellin
Country [120] 0 0
Czechia
State/province [120] 0 0
Benesov
Country [121] 0 0
Czechia
State/province [121] 0 0
Brandys nad Labem
Country [122] 0 0
Czechia
State/province [122] 0 0
Cvikov
Country [123] 0 0
Czechia
State/province [123] 0 0
Holesov
Country [124] 0 0
Czechia
State/province [124] 0 0
Hradec Kralove
Country [125] 0 0
Czechia
State/province [125] 0 0
Jaromer
Country [126] 0 0
Czechia
State/province [126] 0 0
Olomouc
Country [127] 0 0
Czechia
State/province [127] 0 0
Ostrava - Poruba
Country [128] 0 0
Czechia
State/province [128] 0 0
Plzen
Country [129] 0 0
Czechia
State/province [129] 0 0
Praha 5
Country [130] 0 0
Czechia
State/province [130] 0 0
Praha 8
Country [131] 0 0
Czechia
State/province [131] 0 0
Tabor
Country [132] 0 0
Czechia
State/province [132] 0 0
Teplice
Country [133] 0 0
Czechia
State/province [133] 0 0
Trebic
Country [134] 0 0
Denmark
State/province [134] 0 0
Aalborg
Country [135] 0 0
Denmark
State/province [135] 0 0
Aarhus C
Country [136] 0 0
Denmark
State/province [136] 0 0
Hellerup
Country [137] 0 0
Denmark
State/province [137] 0 0
Hvidovre
Country [138] 0 0
Denmark
State/province [138] 0 0
Kolding
Country [139] 0 0
Denmark
State/province [139] 0 0
Odense C
Country [140] 0 0
Denmark
State/province [140] 0 0
Roskilde
Country [141] 0 0
Denmark
State/province [141] 0 0
Sønderborg
Country [142] 0 0
Finland
State/province [142] 0 0
Espoo
Country [143] 0 0
Finland
State/province [143] 0 0
Helsinki
Country [144] 0 0
Finland
State/province [144] 0 0
Jyvaskyla
Country [145] 0 0
Finland
State/province [145] 0 0
Lohja
Country [146] 0 0
Finland
State/province [146] 0 0
Tampere
Country [147] 0 0
Finland
State/province [147] 0 0
Turku
Country [148] 0 0
France
State/province [148] 0 0
Bayonne cedex
Country [149] 0 0
France
State/province [149] 0 0
Brest Cedex
Country [150] 0 0
France
State/province [150] 0 0
Briis-sous-Forge
Country [151] 0 0
France
State/province [151] 0 0
Grenoble cedex 9
Country [152] 0 0
France
State/province [152] 0 0
Le Mans
Country [153] 0 0
France
State/province [153] 0 0
Lyon cedex 04
Country [154] 0 0
France
State/province [154] 0 0
Marseille cedex 03
Country [155] 0 0
France
State/province [155] 0 0
Montauban cedex
Country [156] 0 0
France
State/province [156] 0 0
Montpellier cedex 5
Country [157] 0 0
France
State/province [157] 0 0
Nimes
Country [158] 0 0
France
State/province [158] 0 0
Orléans cedex 2
Country [159] 0 0
France
State/province [159] 0 0
Paris
Country [160] 0 0
France
State/province [160] 0 0
Perpignan
Country [161] 0 0
France
State/province [161] 0 0
Pessac cedex
Country [162] 0 0
France
State/province [162] 0 0
Pringy cedex
Country [163] 0 0
France
State/province [163] 0 0
Rennes Cedex 9
Country [164] 0 0
France
State/province [164] 0 0
Strasbourg cedex
Country [165] 0 0
France
State/province [165] 0 0
Toulon
Country [166] 0 0
France
State/province [166] 0 0
Vandoeuvre-les-Nancy
Country [167] 0 0
Germany
State/province [167] 0 0
Baden-Wuerttemberg
Country [168] 0 0
Germany
State/province [168] 0 0
Bayern
Country [169] 0 0
Germany
State/province [169] 0 0
Brandenburg
Country [170] 0 0
Germany
State/province [170] 0 0
Hessen
Country [171] 0 0
Germany
State/province [171] 0 0
Niedersachsen
Country [172] 0 0
Germany
State/province [172] 0 0
Nordrhein-Westfalen
Country [173] 0 0
Germany
State/province [173] 0 0
Rheinland-Pfalz
Country [174] 0 0
Germany
State/province [174] 0 0
Saarland
Country [175] 0 0
Germany
State/province [175] 0 0
Sachsen-Anhalt
Country [176] 0 0
Germany
State/province [176] 0 0
Sachsen
Country [177] 0 0
Germany
State/province [177] 0 0
Schleswig-Holstein
Country [178] 0 0
Germany
State/province [178] 0 0
Thueringen
Country [179] 0 0
Germany
State/province [179] 0 0
Berlin
Country [180] 0 0
Germany
State/province [180] 0 0
Deggendorf
Country [181] 0 0
Germany
State/province [181] 0 0
Hamburg
Country [182] 0 0
Germany
State/province [182] 0 0
Witten
Country [183] 0 0
Hong Kong
State/province [183] 0 0
Kwun Tong
Country [184] 0 0
Hong Kong
State/province [184] 0 0
Lai Chi Kok
Country [185] 0 0
Hong Kong
State/province [185] 0 0
Pokfulam
Country [186] 0 0
Hong Kong
State/province [186] 0 0
Shatin
Country [187] 0 0
Hong Kong
State/province [187] 0 0
Tuen Mun
Country [188] 0 0
Israel
State/province [188] 0 0
Afula
Country [189] 0 0
Israel
State/province [189] 0 0
Ashkelon
Country [190] 0 0
Israel
State/province [190] 0 0
Haifa
Country [191] 0 0
Israel
State/province [191] 0 0
Holon
Country [192] 0 0
Israel
State/province [192] 0 0
Jerusalem
Country [193] 0 0
Israel
State/province [193] 0 0
Kfar-Saba
Country [194] 0 0
Israel
State/province [194] 0 0
Petah Tikva
Country [195] 0 0
Israel
State/province [195] 0 0
Ramat Gan
Country [196] 0 0
Israel
State/province [196] 0 0
Rehovot
Country [197] 0 0
Israel
State/province [197] 0 0
Tel Aviv
Country [198] 0 0
Israel
State/province [198] 0 0
Tel-Aviv
Country [199] 0 0
Israel
State/province [199] 0 0
Zrifin
Country [200] 0 0
Japan
State/province [200] 0 0
Aichi
Country [201] 0 0
Japan
State/province [201] 0 0
Chiba
Country [202] 0 0
Japan
State/province [202] 0 0
Ehime
Country [203] 0 0
Japan
State/province [203] 0 0
Fukuoka
Country [204] 0 0
Japan
State/province [204] 0 0
Gifu
Country [205] 0 0
Japan
State/province [205] 0 0
Gunma
Country [206] 0 0
Japan
State/province [206] 0 0
Hiroshima
Country [207] 0 0
Japan
State/province [207] 0 0
Hokkaido
Country [208] 0 0
Japan
State/province [208] 0 0
Hyogo
Country [209] 0 0
Japan
State/province [209] 0 0
Ibaraki
Country [210] 0 0
Japan
State/province [210] 0 0
Ishikawa
Country [211] 0 0
Japan
State/province [211] 0 0
Iwate
Country [212] 0 0
Japan
State/province [212] 0 0
Kagawa
Country [213] 0 0
Japan
State/province [213] 0 0
Kanagawa
Country [214] 0 0
Japan
State/province [214] 0 0
Kochi
Country [215] 0 0
Japan
State/province [215] 0 0
Kumamoto
Country [216] 0 0
Japan
State/province [216] 0 0
Kyoto
Country [217] 0 0
Japan
State/province [217] 0 0
Mie
Country [218] 0 0
Japan
State/province [218] 0 0
Miyagi
Country [219] 0 0
Japan
State/province [219] 0 0
Nagano
Country [220] 0 0
Japan
State/province [220] 0 0
Niigata
Country [221] 0 0
Japan
State/province [221] 0 0
Oita
Country [222] 0 0
Japan
State/province [222] 0 0
Okayama
Country [223] 0 0
Japan
State/province [223] 0 0
Okinawa
Country [224] 0 0
Japan
State/province [224] 0 0
Osaka
Country [225] 0 0
Japan
State/province [225] 0 0
Saitama
Country [226] 0 0
Japan
State/province [226] 0 0
Shizuoka
Country [227] 0 0
Japan
State/province [227] 0 0
Tochigi
Country [228] 0 0
Japan
State/province [228] 0 0
Tokyo
Country [229] 0 0
Japan
State/province [229] 0 0
Toyama
Country [230] 0 0
Japan
State/province [230] 0 0
Wakayama
Country [231] 0 0
Japan
State/province [231] 0 0
Yamagata
Country [232] 0 0
Japan
State/province [232] 0 0
Yamanashi
Country [233] 0 0
Korea, Republic of
State/province [233] 0 0
Bucheon city, Gyenggi-do
Country [234] 0 0
Korea, Republic of
State/province [234] 0 0
Cheongju-si, Chungcheongbuk-do
Country [235] 0 0
Korea, Republic of
State/province [235] 0 0
Gyeonggi-do
Country [236] 0 0
Korea, Republic of
State/province [236] 0 0
Incheon
Country [237] 0 0
Korea, Republic of
State/province [237] 0 0
Jeonju-si
Country [238] 0 0
Korea, Republic of
State/province [238] 0 0
Kangwon-do
Country [239] 0 0
Korea, Republic of
State/province [239] 0 0
Seoul
Country [240] 0 0
Korea, Republic of
State/province [240] 0 0
Suwon
Country [241] 0 0
Netherlands
State/province [241] 0 0
Alkmaar
Country [242] 0 0
Netherlands
State/province [242] 0 0
Almelo
Country [243] 0 0
Netherlands
State/province [243] 0 0
Assen
Country [244] 0 0
Netherlands
State/province [244] 0 0
Beek
Country [245] 0 0
Netherlands
State/province [245] 0 0
Breda
Country [246] 0 0
Netherlands
State/province [246] 0 0
Den Bosch
Country [247] 0 0
Netherlands
State/province [247] 0 0
Dordrecht
Country [248] 0 0
Netherlands
State/province [248] 0 0
Eindhoven
Country [249] 0 0
Netherlands
State/province [249] 0 0
Enschede
Country [250] 0 0
Netherlands
State/province [250] 0 0
Groningen
Country [251] 0 0
Netherlands
State/province [251] 0 0
Harderwijk
Country [252] 0 0
Netherlands
State/province [252] 0 0
Helmond
Country [253] 0 0
Netherlands
State/province [253] 0 0
Hoofddorp
Country [254] 0 0
Netherlands
State/province [254] 0 0
Hoorn
Country [255] 0 0
Netherlands
State/province [255] 0 0
Kloosterhaar
Country [256] 0 0
Netherlands
State/province [256] 0 0
Leeuwarden
Country [257] 0 0
Netherlands
State/province [257] 0 0
Nieuwegein
Country [258] 0 0
Netherlands
State/province [258] 0 0
Rotterdam
Country [259] 0 0
Netherlands
State/province [259] 0 0
Sneek
Country [260] 0 0
Netherlands
State/province [260] 0 0
Spijkenisse
Country [261] 0 0
Netherlands
State/province [261] 0 0
Veldhoven
Country [262] 0 0
Netherlands
State/province [262] 0 0
Zutphen
Country [263] 0 0
Netherlands
State/province [263] 0 0
Zwolle
Country [264] 0 0
New Zealand
State/province [264] 0 0
Auckland
Country [265] 0 0
New Zealand
State/province [265] 0 0
Dunedin
Country [266] 0 0
New Zealand
State/province [266] 0 0
Newtown, Wellington
Country [267] 0 0
New Zealand
State/province [267] 0 0
Tauranga
Country [268] 0 0
New Zealand
State/province [268] 0 0
Wellington
Country [269] 0 0
Norway
State/province [269] 0 0
Bodø
Country [270] 0 0
Norway
State/province [270] 0 0
Fredrikstad
Country [271] 0 0
Norway
State/province [271] 0 0
Hakadal
Country [272] 0 0
Norway
State/province [272] 0 0
Kløfta
Country [273] 0 0
Norway
State/province [273] 0 0
Levanger
Country [274] 0 0
Norway
State/province [274] 0 0
Oslo
Country [275] 0 0
Norway
State/province [275] 0 0
Stavanger
Country [276] 0 0
Norway
State/province [276] 0 0
Trondheim
Country [277] 0 0
Peru
State/province [277] 0 0
Lima
Country [278] 0 0
Philippines
State/province [278] 0 0
Caloocan City
Country [279] 0 0
Philippines
State/province [279] 0 0
Iloilo
Country [280] 0 0
Philippines
State/province [280] 0 0
Jaro, Iloilo City
Country [281] 0 0
Philippines
State/province [281] 0 0
Pasig
Country [282] 0 0
Philippines
State/province [282] 0 0
Quezon City
Country [283] 0 0
Poland
State/province [283] 0 0
Bialystok
Country [284] 0 0
Poland
State/province [284] 0 0
Ostrowiec Swietokrzyski
Country [285] 0 0
Poland
State/province [285] 0 0
Sopot
Country [286] 0 0
Poland
State/province [286] 0 0
Szczecin
Country [287] 0 0
Poland
State/province [287] 0 0
Tarnów
Country [288] 0 0
Poland
State/province [288] 0 0
Zgierz
Country [289] 0 0
Puerto Rico
State/province [289] 0 0
Guaynabo
Country [290] 0 0
Puerto Rico
State/province [290] 0 0
Mayaguez
Country [291] 0 0
Puerto Rico
State/province [291] 0 0
Ponce
Country [292] 0 0
Puerto Rico
State/province [292] 0 0
San Juan
Country [293] 0 0
Romania
State/province [293] 0 0
Braila
Country [294] 0 0
Romania
State/province [294] 0 0
Brasov
Country [295] 0 0
Romania
State/province [295] 0 0
Bucharest
Country [296] 0 0
Romania
State/province [296] 0 0
Comuna Alexandru Cel Bun
Country [297] 0 0
Romania
State/province [297] 0 0
Constanta
Country [298] 0 0
Romania
State/province [298] 0 0
Ploiesti
Country [299] 0 0
Romania
State/province [299] 0 0
Ramnicu Valcea
Country [300] 0 0
Russian Federation
State/province [300] 0 0
Barnaul
Country [301] 0 0
Russian Federation
State/province [301] 0 0
Belgorod
Country [302] 0 0
Russian Federation
State/province [302] 0 0
Blagoveshchensk
Country [303] 0 0
Russian Federation
State/province [303] 0 0
Chita
Country [304] 0 0
Russian Federation
State/province [304] 0 0
Ekaterinburg
Country [305] 0 0
Russian Federation
State/province [305] 0 0
Ivanovo
Country [306] 0 0
Russian Federation
State/province [306] 0 0
Kazan
Country [307] 0 0
Russian Federation
State/province [307] 0 0
Krasnodar
Country [308] 0 0
Russian Federation
State/province [308] 0 0
Krasnoyarsk
Country [309] 0 0
Russian Federation
State/province [309] 0 0
Moscow
Country [310] 0 0
Russian Federation
State/province [310] 0 0
Novgorod
Country [311] 0 0
Russian Federation
State/province [311] 0 0
Novosibirsk
Country [312] 0 0
Russian Federation
State/province [312] 0 0
Petrozavodsk
Country [313] 0 0
Russian Federation
State/province [313] 0 0
Pyatigorsk
Country [314] 0 0
Russian Federation
State/province [314] 0 0
Ryazan
Country [315] 0 0
Russian Federation
State/province [315] 0 0
Saint-Petersburg
Country [316] 0 0
Russian Federation
State/province [316] 0 0
Saratov
Country [317] 0 0
Russian Federation
State/province [317] 0 0
St. Petersburg
Country [318] 0 0
Russian Federation
State/province [318] 0 0
Stavropol
Country [319] 0 0
Russian Federation
State/province [319] 0 0
Tomsk
Country [320] 0 0
Russian Federation
State/province [320] 0 0
Ulan-Ude
Country [321] 0 0
Russian Federation
State/province [321] 0 0
Ulyanovsk
Country [322] 0 0
Russian Federation
State/province [322] 0 0
Vladimir
Country [323] 0 0
Russian Federation
State/province [323] 0 0
Vladivostok
Country [324] 0 0
Russian Federation
State/province [324] 0 0
Volgodonsk
Country [325] 0 0
Russian Federation
State/province [325] 0 0
Voronezh
Country [326] 0 0
Russian Federation
State/province [326] 0 0
Vsevolozhsk, Leningrad Region
Country [327] 0 0
Russian Federation
State/province [327] 0 0
Yaroslavl
Country [328] 0 0
Singapore
State/province [328] 0 0
Singapore
Country [329] 0 0
South Africa
State/province [329] 0 0
Gauteng
Country [330] 0 0
South Africa
State/province [330] 0 0
Mpumalanga
Country [331] 0 0
South Africa
State/province [331] 0 0
Amanzimtoti
Country [332] 0 0
South Africa
State/province [332] 0 0
Bellville
Country [333] 0 0
South Africa
State/province [333] 0 0
Bloemfontein
Country [334] 0 0
South Africa
State/province [334] 0 0
Boksburg North
Country [335] 0 0
South Africa
State/province [335] 0 0
Cape Town
Country [336] 0 0
South Africa
State/province [336] 0 0
CapeTown
Country [337] 0 0
South Africa
State/province [337] 0 0
Durban
Country [338] 0 0
South Africa
State/province [338] 0 0
Gatesville
Country [339] 0 0
South Africa
State/province [339] 0 0
Johannesburg
Country [340] 0 0
South Africa
State/province [340] 0 0
Korsten
Country [341] 0 0
South Africa
State/province [341] 0 0
Mowbray
Country [342] 0 0
South Africa
State/province [342] 0 0
Paarl
Country [343] 0 0
South Africa
State/province [343] 0 0
Panorama
Country [344] 0 0
South Africa
State/province [344] 0 0
Tygerberg
Country [345] 0 0
Spain
State/province [345] 0 0
Andalucia
Country [346] 0 0
Spain
State/province [346] 0 0
Cantabria
Country [347] 0 0
Spain
State/province [347] 0 0
Catalonia
Country [348] 0 0
Spain
State/province [348] 0 0
(Badalona) Barcelona
Country [349] 0 0
Spain
State/province [349] 0 0
(Barakaldo) Vizcaya
Country [350] 0 0
Spain
State/province [350] 0 0
Alicante
Country [351] 0 0
Spain
State/province [351] 0 0
Alzira/Valencia
Country [352] 0 0
Spain
State/province [352] 0 0
Barcelona
Country [353] 0 0
Spain
State/province [353] 0 0
Basurto/Bilbao
Country [354] 0 0
Spain
State/province [354] 0 0
Burgos
Country [355] 0 0
Spain
State/province [355] 0 0
Centelles (Barcelona)
Country [356] 0 0
Spain
State/province [356] 0 0
Coslada
Country [357] 0 0
Spain
State/province [357] 0 0
Cáceres
Country [358] 0 0
Spain
State/province [358] 0 0
Gerona
Country [359] 0 0
Spain
State/province [359] 0 0
Girona
Country [360] 0 0
Spain
State/province [360] 0 0
L'Hospitalet de Llobregat
Country [361] 0 0
Spain
State/province [361] 0 0
La Coruña
Country [362] 0 0
Spain
State/province [362] 0 0
La Roca Del Valles (Barcelona)
Country [363] 0 0
Spain
State/province [363] 0 0
Lleida
Country [364] 0 0
Spain
State/province [364] 0 0
Madrid
Country [365] 0 0
Spain
State/province [365] 0 0
Mataró
Country [366] 0 0
Spain
State/province [366] 0 0
Málaga
Country [367] 0 0
Spain
State/province [367] 0 0
Mérida (Badajoz)
Country [368] 0 0
Spain
State/province [368] 0 0
Oviedo
Country [369] 0 0
Spain
State/province [369] 0 0
Palma de Mallorca
Country [370] 0 0
Spain
State/province [370] 0 0
Pamplona
Country [371] 0 0
Spain
State/province [371] 0 0
Peralada( Girona)
Country [372] 0 0
Spain
State/province [372] 0 0
Petrer/Alicante
Country [373] 0 0
Spain
State/province [373] 0 0
Ponferrada (León)
Country [374] 0 0
Spain
State/province [374] 0 0
Pozuelo De Alarcón/Madrid
Country [375] 0 0
Spain
State/province [375] 0 0
Sabadell (Barcelona)
Country [376] 0 0
Spain
State/province [376] 0 0
Sagunto/Valencia
Country [377] 0 0
Spain
State/province [377] 0 0
Salamanca
Country [378] 0 0
Spain
State/province [378] 0 0
San Juan De Alicante
Country [379] 0 0
Spain
State/province [379] 0 0
San Sebastian de los Reyes
Country [380] 0 0
Spain
State/province [380] 0 0
Santander
Country [381] 0 0
Spain
State/province [381] 0 0
Santiago de Compostela
Country [382] 0 0
Spain
State/province [382] 0 0
Sevilla
Country [383] 0 0
Spain
State/province [383] 0 0
Tarragona
Country [384] 0 0
Spain
State/province [384] 0 0
Valencia
Country [385] 0 0
Spain
State/province [385] 0 0
Valladolid
Country [386] 0 0
Spain
State/province [386] 0 0
Vizcaya
Country [387] 0 0
Spain
State/province [387] 0 0
Zaragoza
Country [388] 0 0
Sweden
State/province [388] 0 0
Borås
Country [389] 0 0
Sweden
State/province [389] 0 0
Göteborg
Country [390] 0 0
Sweden
State/province [390] 0 0
Höllviken
Country [391] 0 0
Sweden
State/province [391] 0 0
Linköping
Country [392] 0 0
Sweden
State/province [392] 0 0
Luleå
Country [393] 0 0
Sweden
State/province [393] 0 0
Stockholm
Country [394] 0 0
Sweden
State/province [394] 0 0
Uppsala
Country [395] 0 0
Sweden
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Örebro
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Östersund
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Bangkok
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Chiangmai
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Thailand
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Khon Kaen
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Thailand
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Muang
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Nakhon Ratchasima
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Nan
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Songkla
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Kharkiv
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Kyiv
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Baillieston, Glasgow
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Bradford
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Cambridge
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Chester
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Crawley
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Dundee, Scotland
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Ha Noi
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT02164513
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.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02164513