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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01313676
Registration number
NCT01313676
Ethics application status
Date submitted
3/02/2011
Date registered
14/03/2011
Date last updated
6/08/2018
Titles & IDs
Public title
Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease
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Scientific title
A Clinical Outcomes Study to Compare the Effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg With Placebo on Survival in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD) and a History of or at Increased Risk for Cardiovascular Disease
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Secondary ID [1]
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113782
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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/vilanterol
Treatment: Drugs - fluticasone furoate
Treatment: Drugs - vilanterol
Other interventions - Placebo
Experimental: fluticasone furoate/vilanterol - Combination of both products in one inhaler
Experimental: fluticasone furoate - comparator of individual component
Experimental: vilanterol - comparator of individual component
Placebo comparator: placebo - once daily via inhaler
Treatment: Drugs: fluticasone furoate/vilanterol
100/25mcg given once daily via novel dry powder inhaler
Treatment: Drugs: fluticasone furoate
100mcg given once daily via novel dry powder inhaler
Treatment: Drugs: vilanterol
25mcg given once daily via novel dry powder inhaler
Other interventions: Placebo
placebo comparator once daily via novel dry powder inhaler
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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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Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date
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Assessment method [1]
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Death from any cause: which occurred from the day of starting IP until the Commone End Date (CED). Common End Date (CED) is the study end date that was pre determined where approximately 1000 deaths would have occurred in the Intent-toTreat Efficacy (ITT-E) Population. Only deaths which occurred on or before the CED were used for the primary analysis. Those who had not died by CED, but who were known to be alive on or after the CED, were censored at the CED. Cox Proportional Hazards (PH) Model was adjusted for age, and gender, including all 4 arms. A hazard ratio of less than 1 indicates a lower death rate versus placebo or other arm. ITT-E Population consisted of all participants in the Safety Population (i.e. randomized to IP and who received at least one dose of IP), with the exception of those recruited at sites that were closed.
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Timepoint [1]
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From the date of randomization until date of death due to any cause (average of 2 study years)
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Secondary outcome [1]
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Decline in Forced Expiratory Volume in 1 Second (FEV1)
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Assessment method [1]
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The effect of treatment on decline of post bronchodilator FEV1 recorded during the treatment period was analyzed using a particular form of a mixed effect model - a random coefficients model. FEV1 was fitted as the response variable with treatment group, age, gender, baseline FEV1 and time on treatment as fixed effects. Time on treatment was treated as a continuous variable. This model allowed for an initial increase in FEV1, but then tested the difference in slopes from the first post-baseline measurement which was at 3 months. A negative slope indicates a decline. A positive treatment difference indicates a slower rate of decline vs Placebo or Component. Only participants with at least one on-treatment post-bronchodilator FEV1 measurement were analyzed.
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Timepoint [1]
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From start date of IP until IP stop date + 1 (assessed up to 4 years)
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Secondary outcome [2]
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Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date
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Assessment method [2]
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On-treatment CV composite event is comprised of the first event that is adjudicated as on-treatment CV death, myocardial infarction, stroke, unstable angina, or transient ischemic attack experienced by a participant. The events that occurred no more than 7 days after the participants last dose of IP are considered as on-treatment adverse events. Common end date is the study end date where approximately 1000 deaths would have occurred in the ITT-E Population. Cox PH Model was used to assess time to first on-treatment CV composite event. Cox PH Model was adjusted for age, gender and indicators of ischemic and vascular disease, including all four treatment arms. A hazard ratio less than 1 indicates a lower risk of a first CV event rate versus placebo or any arm.
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Timepoint [2]
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From the start of IP to first on treatment CV event till 7 days after the last dose of IP (average of 2 study years)
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Eligibility
Key inclusion criteria
* Type of subject: outpatient.
* Informed consent: Subjects must give their signed and dated written informed consent to participate.
* Gender: Male or female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
* Age: >=40 and <=80 years of age at Screening (Visit 1).
* Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
* Airflow Obstruction:
Subjects with a measured post-albuterol/salbutamol forced expiratory volume in 1 second (FEV1)/(forced vital capacity)FVC ratio of <=0.70 at Screening (Visit 1).
Subjects with a measured post-albuterol/salbutamol FEV1 >=50 and <=70% of predicted normal values calculated using NHANES III reference equations [Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1).
Post-bronchodilator spirometry will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI )with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated.
* Symptoms of COPD: Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1)
* Cardiovascular disease:
For patients >= 40 years of age: any one of the following:
Established (i.e. by clinical signs or imaging studies) coronary artery disease (CAD) Established (i.e. by clinical signs or imaging studies) peripheral vascular disease (PVD) Previous stroke Previous MI Diabetes mellitus with target organ disease OR
For patients >=60 years of age: any 2 of the following:
Being treated for hypercholesterolemia Being treated for hypertension Being treated for diabetes mellitus Being treated for peripheral vascular disease
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Minimum age
40
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Maximum age
80
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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.
* Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they also have a current diagnosis of COPD).
* alpha 1-antitrypsin deficiency: Subjects with known alpha-1 antitrypsin deficiency as the underlying cause of COPD.
* Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
* Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant.
* A moderate/severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).
* Current severe heart failure (New York Heart Association class IV). Subjects will also be excluded if they have a known ejection fraction of <30% or if they have an implantable cardioverter defibrillator (ICD).
* Other diseases/abnormalities: Any life-threatening condition with life expectancy <3 years, other than vascular disease or COPD, that might prevent the subject from completing the study.
* End stage chronic renal disease: Subjects will be excluded if on renal replacement therapy (hemodialysis or peritoneal).
* Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.
* Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years.
* Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. <=12 hours per day) is not exclusionary.
* 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 or the potential compliance to study procedures.
* Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.
* Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study (unless otherwise specified):
Medication No use within the following time intervals prior to Screening or thereafter at any time during the study (unless otherwise specified) Inhaled Long acting beta-agonists (LABA) 48 hours ICS/LABA combination products 48 hours Inhaled corticosteroids 48 hours Tiotropium 1 week Systemic, Oral, parenteral, intra-articular corticosteroids 30 days (oral and systemic corticosteroids may be used to treat COPD exacerbations during the study) Cytochrome P450 3A4 strong inhibitors including but not limited to antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saquinavir); Imidazole and Triazole anti-fungals (e.g. Ketaconazole, Itraconazole); Clarithromycin, Telithromycin, Amiodarone, and Nefazodone 6 weeks Grapefruit is allowed up to Visit 1, then limited to no more than one glass of grapefruit juice (250 mL/ 8 ounces) or one grapefruit per day 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 administering the treatment/s
The people assessing the outcomes
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
25/01/2011
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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
15/07/2015
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Sample size
Target
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Accrual to date
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Final
16568
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Cairns
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GSK Investigational Site - Glen Osmond
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4870 - Cairns
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4020 - Redcliffe
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5042 - Bedford Park
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5041 - Daw Park
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3011 - Footscray
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3220 - Geelong
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3004 - Melbourne
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Recruitment postcode(s) [8]
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5064 - Glen Osmond
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Recruitment outside Australia
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Bosnia and Herzegovina
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State/province [93]
0
0
Bijeljina
Query!
Country [94]
0
0
Bosnia and Herzegovina
Query!
State/province [94]
0
0
Brcko
Query!
Country [95]
0
0
Bosnia and Herzegovina
Query!
State/province [95]
0
0
Foca
Query!
Country [96]
0
0
Bosnia and Herzegovina
Query!
State/province [96]
0
0
Gracanica
Query!
Country [97]
0
0
Bosnia and Herzegovina
Query!
State/province [97]
0
0
Gradiska
Query!
Country [98]
0
0
Bosnia and Herzegovina
Query!
State/province [98]
0
0
Istocno Sarajevo
Query!
Country [99]
0
0
Bosnia and Herzegovina
Query!
State/province [99]
0
0
Konjic
Query!
Country [100]
0
0
Bosnia and Herzegovina
Query!
State/province [100]
0
0
Mostar
Query!
Country [101]
0
0
Bosnia and Herzegovina
Query!
State/province [101]
0
0
Novi Travnik
Query!
Country [102]
0
0
Bosnia and Herzegovina
Query!
State/province [102]
0
0
Pale
Query!
Country [103]
0
0
Bosnia and Herzegovina
Query!
State/province [103]
0
0
Sarajevo
Query!
Country [104]
0
0
Bosnia and Herzegovina
Query!
State/province [104]
0
0
Srebrenik
Query!
Country [105]
0
0
Bosnia and Herzegovina
Query!
State/province [105]
0
0
Tesanj
Query!
Country [106]
0
0
Bosnia and Herzegovina
Query!
State/province [106]
0
0
Teslic
Query!
Country [107]
0
0
Bosnia and Herzegovina
Query!
State/province [107]
0
0
Travnik
Query!
Country [108]
0
0
Bosnia and Herzegovina
Query!
State/province [108]
0
0
Trebinje
Query!
Country [109]
0
0
Bosnia and Herzegovina
Query!
State/province [109]
0
0
Tuzla
Query!
Country [110]
0
0
Bosnia and Herzegovina
Query!
State/province [110]
0
0
Visegrad
Query!
Country [111]
0
0
Bosnia and Herzegovina
Query!
State/province [111]
0
0
Zenica
Query!
Country [112]
0
0
Bulgaria
Query!
State/province [112]
0
0
Blagoevgrad
Query!
Country [113]
0
0
Bulgaria
Query!
State/province [113]
0
0
Dimitrovgrad
Query!
Country [114]
0
0
Bulgaria
Query!
State/province [114]
0
0
Gabrovo
Query!
Country [115]
0
0
Bulgaria
Query!
State/province [115]
0
0
Kozlodui
Query!
Country [116]
0
0
Bulgaria
Query!
State/province [116]
0
0
Lovech
Query!
Country [117]
0
0
Bulgaria
Query!
State/province [117]
0
0
Pazardjik
Query!
Country [118]
0
0
Bulgaria
Query!
State/province [118]
0
0
Petrich
Query!
Country [119]
0
0
Bulgaria
Query!
State/province [119]
0
0
Pleven
Query!
Country [120]
0
0
Bulgaria
Query!
State/province [120]
0
0
Plovdiv
Query!
Country [121]
0
0
Bulgaria
Query!
State/province [121]
0
0
Razgrad
Query!
Country [122]
0
0
Bulgaria
Query!
State/province [122]
0
0
Rousse
Query!
Country [123]
0
0
Bulgaria
Query!
State/province [123]
0
0
Sevlievo
Query!
Country [124]
0
0
Bulgaria
Query!
State/province [124]
0
0
Sliven
Query!
Country [125]
0
0
Bulgaria
Query!
State/province [125]
0
0
Sofia
Query!
Country [126]
0
0
Bulgaria
Query!
State/province [126]
0
0
Stara Zagora
Query!
Country [127]
0
0
Bulgaria
Query!
State/province [127]
0
0
Troyan
Query!
Country [128]
0
0
Bulgaria
Query!
State/province [128]
0
0
Varna
Query!
Country [129]
0
0
Bulgaria
Query!
State/province [129]
0
0
Veliko Tarnovo
Query!
Country [130]
0
0
Bulgaria
Query!
State/province [130]
0
0
Vidin
Query!
Country [131]
0
0
Canada
Query!
State/province [131]
0
0
Alberta
Query!
Country [132]
0
0
Canada
Query!
State/province [132]
0
0
British Columbia
Query!
Country [133]
0
0
Canada
Query!
State/province [133]
0
0
Manitoba
Query!
Country [134]
0
0
Canada
Query!
State/province [134]
0
0
Ontario
Query!
Country [135]
0
0
Canada
Query!
State/province [135]
0
0
Quebec
Query!
Country [136]
0
0
Chile
Query!
State/province [136]
0
0
Región De La Araucania
Query!
Country [137]
0
0
Chile
Query!
State/province [137]
0
0
Región Metro De Santiago
Query!
Country [138]
0
0
Chile
Query!
State/province [138]
0
0
Valparaíso
Query!
Country [139]
0
0
China
Query!
State/province [139]
0
0
Guangdong
Query!
Country [140]
0
0
China
Query!
State/province [140]
0
0
Guangxi
Query!
Country [141]
0
0
China
Query!
State/province [141]
0
0
Hainan
Query!
Country [142]
0
0
China
Query!
State/province [142]
0
0
Hebei
Query!
Country [143]
0
0
China
Query!
State/province [143]
0
0
Hubei
Query!
Country [144]
0
0
China
Query!
State/province [144]
0
0
Inner Mongolia
Query!
Country [145]
0
0
China
Query!
State/province [145]
0
0
Liaoning
Query!
Country [146]
0
0
China
Query!
State/province [146]
0
0
Ningxia
Query!
Country [147]
0
0
China
Query!
State/province [147]
0
0
Shaanxi
Query!
Country [148]
0
0
China
Query!
State/province [148]
0
0
Shandong
Query!
Country [149]
0
0
China
Query!
State/province [149]
0
0
Shanxi
Query!
Country [150]
0
0
China
Query!
State/province [150]
0
0
Sichuan
Query!
Country [151]
0
0
China
Query!
State/province [151]
0
0
Baotou
Query!
Country [152]
0
0
China
Query!
State/province [152]
0
0
Beijing
Query!
Country [153]
0
0
China
Query!
State/province [153]
0
0
Bengbu
Query!
Country [154]
0
0
China
Query!
State/province [154]
0
0
Changchun
Query!
Country [155]
0
0
China
Query!
State/province [155]
0
0
Chengdu
Query!
Country [156]
0
0
China
Query!
State/province [156]
0
0
Chongqing
Query!
Country [157]
0
0
China
Query!
State/province [157]
0
0
Fu Zhou
Query!
Country [158]
0
0
China
Query!
State/province [158]
0
0
Fuzhou
Query!
Country [159]
0
0
China
Query!
State/province [159]
0
0
Guangzhou
Query!
Country [160]
0
0
China
Query!
State/province [160]
0
0
Hangzhou
Query!
Country [161]
0
0
China
Query!
State/province [161]
0
0
Hefei
Query!
Country [162]
0
0
China
Query!
State/province [162]
0
0
Huai'an
Query!
Country [163]
0
0
China
Query!
State/province [163]
0
0
Jiangyin
Query!
Country [164]
0
0
China
Query!
State/province [164]
0
0
Luzhou
Query!
Country [165]
0
0
China
Query!
State/province [165]
0
0
Nanchang
Query!
Country [166]
0
0
China
Query!
State/province [166]
0
0
Nanjing
Query!
Country [167]
0
0
China
Query!
State/province [167]
0
0
Shanghai
Query!
Country [168]
0
0
China
Query!
State/province [168]
0
0
ShangHai
Query!
Country [169]
0
0
China
Query!
State/province [169]
0
0
Tianjin
Query!
Country [170]
0
0
China
Query!
State/province [170]
0
0
Wuxi
Query!
Country [171]
0
0
Colombia
Query!
State/province [171]
0
0
Barranquilla
Query!
Country [172]
0
0
Colombia
Query!
State/province [172]
0
0
Bogota
Query!
Country [173]
0
0
Colombia
Query!
State/province [173]
0
0
Bogotá
Query!
Country [174]
0
0
Colombia
Query!
State/province [174]
0
0
Cali
Query!
Country [175]
0
0
Colombia
Query!
State/province [175]
0
0
Medellin
Query!
Country [176]
0
0
Colombia
Query!
State/province [176]
0
0
Zipaquira
Query!
Country [177]
0
0
Croatia
Query!
State/province [177]
0
0
Cakovec
Query!
Country [178]
0
0
Croatia
Query!
State/province [178]
0
0
Draganic
Query!
Country [179]
0
0
Croatia
Query!
State/province [179]
0
0
Hrasce Turopoljsko
Query!
Country [180]
0
0
Croatia
Query!
State/province [180]
0
0
Hreljin
Query!
Country [181]
0
0
Croatia
Query!
State/province [181]
0
0
Ivankovo
Query!
Country [182]
0
0
Croatia
Query!
State/province [182]
0
0
Karlovac
Query!
Country [183]
0
0
Croatia
Query!
State/province [183]
0
0
Klenovnik
Query!
Country [184]
0
0
Croatia
Query!
State/province [184]
0
0
Krapina
Query!
Country [185]
0
0
Croatia
Query!
State/province [185]
0
0
Kutina
Query!
Country [186]
0
0
Croatia
Query!
State/province [186]
0
0
Novi Marof
Query!
Country [187]
0
0
Croatia
Query!
State/province [187]
0
0
Osijek
Query!
Country [188]
0
0
Croatia
Query!
State/province [188]
0
0
Retkovci
Query!
Country [189]
0
0
Croatia
Query!
State/province [189]
0
0
Rijeka
Query!
Country [190]
0
0
Croatia
Query!
State/province [190]
0
0
Samobor
Query!
Country [191]
0
0
Croatia
Query!
State/province [191]
0
0
Senj
Query!
Country [192]
0
0
Croatia
Query!
State/province [192]
0
0
Sibenik
Query!
Country [193]
0
0
Croatia
Query!
State/province [193]
0
0
Sisak
Query!
Country [194]
0
0
Croatia
Query!
State/province [194]
0
0
Split
Query!
Country [195]
0
0
Croatia
Query!
State/province [195]
0
0
Strmec Samoborski
Query!
Country [196]
0
0
Croatia
Query!
State/province [196]
0
0
Stubicke toplice
Query!
Country [197]
0
0
Croatia
Query!
State/province [197]
0
0
Sukosan
Query!
Country [198]
0
0
Croatia
Query!
State/province [198]
0
0
Varazdin
Query!
Country [199]
0
0
Croatia
Query!
State/province [199]
0
0
Zabok
Query!
Country [200]
0
0
Croatia
Query!
State/province [200]
0
0
Zadar
Query!
Country [201]
0
0
Croatia
Query!
State/province [201]
0
0
Zagreb
Query!
Country [202]
0
0
Czechia
Query!
State/province [202]
0
0
Benesov
Query!
Country [203]
0
0
Czechia
Query!
State/province [203]
0
0
Beroun
Query!
Country [204]
0
0
Czechia
Query!
State/province [204]
0
0
Brno
Query!
Country [205]
0
0
Czechia
Query!
State/province [205]
0
0
Havlickuv brod
Query!
Country [206]
0
0
Czechia
Query!
State/province [206]
0
0
Hlucin
Query!
Country [207]
0
0
Czechia
Query!
State/province [207]
0
0
Holesov
Query!
Country [208]
0
0
Czechia
Query!
State/province [208]
0
0
Jaromer
Query!
Country [209]
0
0
Czechia
Query!
State/province [209]
0
0
Jindrichuv Hradec
Query!
Country [210]
0
0
Czechia
Query!
State/province [210]
0
0
Kolin
Query!
Country [211]
0
0
Czechia
Query!
State/province [211]
0
0
Kralupy nad Vltavou
Query!
Country [212]
0
0
Czechia
Query!
State/province [212]
0
0
Kromeriz
Query!
Country [213]
0
0
Czechia
Query!
State/province [213]
0
0
Liberec
Query!
Country [214]
0
0
Czechia
Query!
State/province [214]
0
0
Melnik
Query!
Country [215]
0
0
Czechia
Query!
State/province [215]
0
0
Moravsky Krumlov
Query!
Country [216]
0
0
Czechia
Query!
State/province [216]
0
0
Neratovice
Query!
Country [217]
0
0
Czechia
Query!
State/province [217]
0
0
Novy Jicin
Query!
Country [218]
0
0
Czechia
Query!
State/province [218]
0
0
Ostrava - Belsky les
Query!
Country [219]
0
0
Czechia
Query!
State/province [219]
0
0
Ostrava - Poruba
Query!
Country [220]
0
0
Czechia
Query!
State/province [220]
0
0
Ostrava
Query!
Country [221]
0
0
Czechia
Query!
State/province [221]
0
0
Plzen
Query!
Country [222]
0
0
Czechia
Query!
State/province [222]
0
0
Praha 13
Query!
Country [223]
0
0
Czechia
Query!
State/province [223]
0
0
Praha 17
Query!
Country [224]
0
0
Czechia
Query!
State/province [224]
0
0
Praha 1
Query!
Country [225]
0
0
Czechia
Query!
State/province [225]
0
0
Praha 3
Query!
Country [226]
0
0
Czechia
Query!
State/province [226]
0
0
Praha 4
Query!
Country [227]
0
0
Czechia
Query!
State/province [227]
0
0
Praha 5
Query!
Country [228]
0
0
Czechia
Query!
State/province [228]
0
0
Praha 6
Query!
Country [229]
0
0
Czechia
Query!
State/province [229]
0
0
Rokycany
Query!
Country [230]
0
0
Czechia
Query!
State/province [230]
0
0
Rudna
Query!
Country [231]
0
0
Czechia
Query!
State/province [231]
0
0
Strakonice
Query!
Country [232]
0
0
Czechia
Query!
State/province [232]
0
0
Svitavy
Query!
Country [233]
0
0
Czechia
Query!
State/province [233]
0
0
Tremosna
Query!
Country [234]
0
0
Czechia
Query!
State/province [234]
0
0
Usti Nad Labem - Klise
Query!
Country [235]
0
0
Czechia
Query!
State/province [235]
0
0
Zatec
Query!
Country [236]
0
0
France
Query!
State/province [236]
0
0
Ferolles Attilly
Query!
Country [237]
0
0
France
Query!
State/province [237]
0
0
Paris Cedex 04
Query!
Country [238]
0
0
France
Query!
State/province [238]
0
0
Strasbourg Cedex
Query!
Country [239]
0
0
France
Query!
State/province [239]
0
0
Tarbes
Query!
Country [240]
0
0
France
Query!
State/province [240]
0
0
Toulouse cedex 9
Query!
Country [241]
0
0
Georgia
Query!
State/province [241]
0
0
Batumi
Query!
Country [242]
0
0
Georgia
Query!
State/province [242]
0
0
Gurjaani
Query!
Country [243]
0
0
Georgia
Query!
State/province [243]
0
0
Kutaisi
Query!
Country [244]
0
0
Georgia
Query!
State/province [244]
0
0
Kvemo Kartli
Query!
Country [245]
0
0
Georgia
Query!
State/province [245]
0
0
Tbilisi
Query!
Country [246]
0
0
Germany
Query!
State/province [246]
0
0
Baden-Wuerttemberg
Query!
Country [247]
0
0
Germany
Query!
State/province [247]
0
0
Bayern
Query!
Country [248]
0
0
Germany
Query!
State/province [248]
0
0
Brandenburg
Query!
Country [249]
0
0
Germany
Query!
State/province [249]
0
0
Hessen
Query!
Country [250]
0
0
Germany
Query!
State/province [250]
0
0
Niedersachsen
Query!
Country [251]
0
0
Germany
Query!
State/province [251]
0
0
Nordrhein-Westfalen
Query!
Country [252]
0
0
Germany
Query!
State/province [252]
0
0
Rheinland-Pfalz
Query!
Country [253]
0
0
Germany
Query!
State/province [253]
0
0
Sachsen-Anhalt
Query!
Country [254]
0
0
Germany
Query!
State/province [254]
0
0
Sachsen
Query!
Country [255]
0
0
Germany
Query!
State/province [255]
0
0
Schleswig-Holstein
Query!
Country [256]
0
0
Germany
Query!
State/province [256]
0
0
Thueringen
Query!
Country [257]
0
0
Germany
Query!
State/province [257]
0
0
Berlin
Query!
Country [258]
0
0
Germany
Query!
State/province [258]
0
0
Hamburg
Query!
Country [259]
0
0
Germany
Query!
State/province [259]
0
0
München
Query!
Country [260]
0
0
Greece
Query!
State/province [260]
0
0
Athens
Query!
Country [261]
0
0
Greece
Query!
State/province [261]
0
0
Thessaloniki
Query!
Country [262]
0
0
Hungary
Query!
State/province [262]
0
0
Balassagyarmat
Query!
Country [263]
0
0
Hungary
Query!
State/province [263]
0
0
Budapest
Query!
Country [264]
0
0
Hungary
Query!
State/province [264]
0
0
Debrecen
Query!
Country [265]
0
0
Hungary
Query!
State/province [265]
0
0
Gyula
Query!
Country [266]
0
0
Hungary
Query!
State/province [266]
0
0
Kaposvár
Query!
Country [267]
0
0
Hungary
Query!
State/province [267]
0
0
Komarom
Query!
Country [268]
0
0
Hungary
Query!
State/province [268]
0
0
Komló
Query!
Country [269]
0
0
Hungary
Query!
State/province [269]
0
0
Mosonmagyaróvár
Query!
Country [270]
0
0
Hungary
Query!
State/province [270]
0
0
Nagykanizsa
Query!
Country [271]
0
0
Hungary
Query!
State/province [271]
0
0
Nyiregyhaza
Query!
Country [272]
0
0
Hungary
Query!
State/province [272]
0
0
Pécs
Query!
Country [273]
0
0
Hungary
Query!
State/province [273]
0
0
Sopron
Query!
Country [274]
0
0
Hungary
Query!
State/province [274]
0
0
Szigetszentmiklos
Query!
Country [275]
0
0
Hungary
Query!
State/province [275]
0
0
Szikszó
Query!
Country [276]
0
0
Hungary
Query!
State/province [276]
0
0
Szombathely
Query!
Country [277]
0
0
Hungary
Query!
State/province [277]
0
0
Tatabanya
Query!
Country [278]
0
0
Hungary
Query!
State/province [278]
0
0
Vasarosnameny
Query!
Country [279]
0
0
Hungary
Query!
State/province [279]
0
0
Zalaegerszeg
Query!
Country [280]
0
0
India
Query!
State/province [280]
0
0
Ahmedabad
Query!
Country [281]
0
0
India
Query!
State/province [281]
0
0
Alappuzha
Query!
Country [282]
0
0
India
Query!
State/province [282]
0
0
Angamaly
Query!
Country [283]
0
0
India
Query!
State/province [283]
0
0
Aurangabad
Query!
Country [284]
0
0
India
Query!
State/province [284]
0
0
Bangalore
Query!
Country [285]
0
0
India
Query!
State/province [285]
0
0
Chennai
Query!
Country [286]
0
0
India
Query!
State/province [286]
0
0
Guntur
Query!
Country [287]
0
0
India
Query!
State/province [287]
0
0
Hyderabad
Query!
Country [288]
0
0
India
Query!
State/province [288]
0
0
Jaipur
Query!
Country [289]
0
0
India
Query!
State/province [289]
0
0
Lucknow
Query!
Country [290]
0
0
India
Query!
State/province [290]
0
0
Mysore
Query!
Country [291]
0
0
India
Query!
State/province [291]
0
0
Nagpur
Query!
Country [292]
0
0
India
Query!
State/province [292]
0
0
Nashik
Query!
Country [293]
0
0
India
Query!
State/province [293]
0
0
Nasik
Query!
Country [294]
0
0
India
Query!
State/province [294]
0
0
Pune
Query!
Country [295]
0
0
India
Query!
State/province [295]
0
0
Trisshur
Query!
Country [296]
0
0
India
Query!
State/province [296]
0
0
Trivandrum
Query!
Country [297]
0
0
India
Query!
State/province [297]
0
0
Varanasi
Query!
Country [298]
0
0
India
Query!
State/province [298]
0
0
Vijayawada
Query!
Country [299]
0
0
Indonesia
Query!
State/province [299]
0
0
Banda Aceh
Query!
Country [300]
0
0
Indonesia
Query!
State/province [300]
0
0
Banjarmasin
Query!
Country [301]
0
0
Indonesia
Query!
State/province [301]
0
0
Bukittinggi
Query!
Country [302]
0
0
Indonesia
Query!
State/province [302]
0
0
Denpasar
Query!
Country [303]
0
0
Indonesia
Query!
State/province [303]
0
0
Depok Timur
Query!
Country [304]
0
0
Indonesia
Query!
State/province [304]
0
0
Jakarta
Query!
Country [305]
0
0
Indonesia
Query!
State/province [305]
0
0
Lampung Selatan
Query!
Country [306]
0
0
Indonesia
Query!
State/province [306]
0
0
Makassar
Query!
Country [307]
0
0
Indonesia
Query!
State/province [307]
0
0
Malang
Query!
Country [308]
0
0
Indonesia
Query!
State/province [308]
0
0
Medan
Query!
Country [309]
0
0
Indonesia
Query!
State/province [309]
0
0
Padang
Query!
Country [310]
0
0
Indonesia
Query!
State/province [310]
0
0
Palembang
Query!
Country [311]
0
0
Indonesia
Query!
State/province [311]
0
0
Pekanbaru
Query!
Country [312]
0
0
Indonesia
Query!
State/province [312]
0
0
Pontianak
Query!
Country [313]
0
0
Indonesia
Query!
State/province [313]
0
0
Pringsewu
Query!
Country [314]
0
0
Indonesia
Query!
State/province [314]
0
0
Semarang
Query!
Country [315]
0
0
Indonesia
Query!
State/province [315]
0
0
Surabaya
Query!
Country [316]
0
0
Indonesia
Query!
State/province [316]
0
0
Surakarta
Query!
Country [317]
0
0
Indonesia
Query!
State/province [317]
0
0
Yogyakarta
Query!
Country [318]
0
0
Israel
Query!
State/province [318]
0
0
Afula
Query!
Country [319]
0
0
Israel
Query!
State/province [319]
0
0
Ashkelon
Query!
Country [320]
0
0
Israel
Query!
State/province [320]
0
0
Beer-Sheba
Query!
Country [321]
0
0
Israel
Query!
State/province [321]
0
0
Hadera
Query!
Country [322]
0
0
Israel
Query!
State/province [322]
0
0
Haifa
Query!
Country [323]
0
0
Israel
Query!
State/province [323]
0
0
Holon
Query!
Country [324]
0
0
Israel
Query!
State/province [324]
0
0
Jerusalem
Query!
Country [325]
0
0
Israel
Query!
State/province [325]
0
0
Kfar Saba
Query!
Country [326]
0
0
Israel
Query!
State/province [326]
0
0
Rehovot
Query!
Country [327]
0
0
Israel
Query!
State/province [327]
0
0
Tel Aviv
Query!
Country [328]
0
0
Israel
Query!
State/province [328]
0
0
Tel Hashomer
Query!
Country [329]
0
0
Italy
Query!
State/province [329]
0
0
Friuli-Venezia-Giulia
Query!
Country [330]
0
0
Japan
Query!
State/province [330]
0
0
Aichi
Query!
Country [331]
0
0
Japan
Query!
State/province [331]
0
0
Fukuoka
Query!
Country [332]
0
0
Japan
Query!
State/province [332]
0
0
Gifu
Query!
Country [333]
0
0
Japan
Query!
State/province [333]
0
0
Hokkaido
Query!
Country [334]
0
0
Japan
Query!
State/province [334]
0
0
Hyogo
Query!
Country [335]
0
0
Japan
Query!
State/province [335]
0
0
Ibaraki
Query!
Country [336]
0
0
Japan
Query!
State/province [336]
0
0
Kagawa
Query!
Country [337]
0
0
Japan
Query!
State/province [337]
0
0
Kodaira
Query!
Country [338]
0
0
Japan
Query!
State/province [338]
0
0
Kumamoto
Query!
Country [339]
0
0
Japan
Query!
State/province [339]
0
0
Kyoto
Query!
Country [340]
0
0
Japan
Query!
State/province [340]
0
0
Oita
Query!
Country [341]
0
0
Japan
Query!
State/province [341]
0
0
Osaka
Query!
Country [342]
0
0
Japan
Query!
State/province [342]
0
0
Shimane
Query!
Country [343]
0
0
Japan
Query!
State/province [343]
0
0
Tokyo
Query!
Country [344]
0
0
Korea, Republic of
Query!
State/province [344]
0
0
Bucheon-Si, Gyeonggi-Do
Query!
Country [345]
0
0
Korea, Republic of
Query!
State/province [345]
0
0
Bucheon
Query!
Country [346]
0
0
Korea, Republic of
Query!
State/province [346]
0
0
Busan
Query!
Country [347]
0
0
Korea, Republic of
Query!
State/province [347]
0
0
Cheonan
Query!
Country [348]
0
0
Korea, Republic of
Query!
State/province [348]
0
0
Chonju-si
Query!
Country [349]
0
0
Korea, Republic of
Query!
State/province [349]
0
0
Daegu
Query!
Country [350]
0
0
Korea, Republic of
Query!
State/province [350]
0
0
Daejeon
Query!
Country [351]
0
0
Korea, Republic of
Query!
State/province [351]
0
0
Goyang-si
Query!
Country [352]
0
0
Korea, Republic of
Query!
State/province [352]
0
0
Guri-si
Query!
Country [353]
0
0
Korea, Republic of
Query!
State/province [353]
0
0
Gwangju
Query!
Country [354]
0
0
Korea, Republic of
Query!
State/province [354]
0
0
Gyeonggi-do
Query!
Country [355]
0
0
Korea, Republic of
Query!
State/province [355]
0
0
Incheon
Query!
Country [356]
0
0
Korea, Republic of
Query!
State/province [356]
0
0
Kangwon
Query!
Country [357]
0
0
Korea, Republic of
Query!
State/province [357]
0
0
Seongnam
Query!
Country [358]
0
0
Korea, Republic of
Query!
State/province [358]
0
0
Seoul
Query!
Country [359]
0
0
Korea, Republic of
Query!
State/province [359]
0
0
Suwon, Gyeonggi-do
Query!
Country [360]
0
0
Korea, Republic of
Query!
State/province [360]
0
0
Uijeongbu, Gyeonggi-do
Query!
Country [361]
0
0
Korea, Republic of
Query!
State/province [361]
0
0
Ulsan
Query!
Country [362]
0
0
Korea, Republic of
Query!
State/province [362]
0
0
Wonju-si, Kanwon-do
Query!
Country [363]
0
0
Latvia
Query!
State/province [363]
0
0
Balvi
Query!
Country [364]
0
0
Latvia
Query!
State/province [364]
0
0
Daugavpils
Query!
Country [365]
0
0
Latvia
Query!
State/province [365]
0
0
Jekabpils
Query!
Country [366]
0
0
Latvia
Query!
State/province [366]
0
0
Jelgava
Query!
Country [367]
0
0
Latvia
Query!
State/province [367]
0
0
Jurmala
Query!
Country [368]
0
0
Latvia
Query!
State/province [368]
0
0
Kraslava
Query!
Country [369]
0
0
Latvia
Query!
State/province [369]
0
0
Kuldiga
Query!
Country [370]
0
0
Latvia
Query!
State/province [370]
0
0
Liepaja
Query!
Country [371]
0
0
Latvia
Query!
State/province [371]
0
0
Ogre
Query!
Country [372]
0
0
Latvia
Query!
State/province [372]
0
0
Riga
Query!
Country [373]
0
0
Latvia
Query!
State/province [373]
0
0
Talsi
Query!
Country [374]
0
0
Latvia
Query!
State/province [374]
0
0
Tukums
Query!
Country [375]
0
0
Latvia
Query!
State/province [375]
0
0
Valmiera
Query!
Country [376]
0
0
Latvia
Query!
State/province [376]
0
0
Ventspils
Query!
Country [377]
0
0
Macedonia, The Former Yugoslav Republic of
Query!
State/province [377]
0
0
Bitola
Query!
Country [378]
0
0
Macedonia, The Former Yugoslav Republic of
Query!
State/province [378]
0
0
Gostivar
Query!
Country [379]
0
0
Macedonia, The Former Yugoslav Republic of
Query!
State/province [379]
0
0
Ohrid
Query!
Country [380]
0
0
Macedonia, The Former Yugoslav Republic of
Query!
State/province [380]
0
0
Prilep
Query!
Country [381]
0
0
Macedonia, The Former Yugoslav Republic of
Query!
State/province [381]
0
0
Shtip
Query!
Country [382]
0
0
Macedonia, The Former Yugoslav Republic of
Query!
State/province [382]
0
0
Skopje
Query!
Country [383]
0
0
Macedonia, The Former Yugoslav Republic of
Query!
State/province [383]
0
0
Strumica
Query!
Country [384]
0
0
Macedonia, The Former Yugoslav Republic of
Query!
State/province [384]
0
0
Veles
Query!
Country [385]
0
0
Malaysia
Query!
State/province [385]
0
0
Johor Bahru
Query!
Country [386]
0
0
Malaysia
Query!
State/province [386]
0
0
Kuala Lumpur
Query!
Country [387]
0
0
Malaysia
Query!
State/province [387]
0
0
Kuala Pilah
Query!
Country [388]
0
0
Malaysia
Query!
State/province [388]
0
0
Kuching
Query!
Country [389]
0
0
Malaysia
Query!
State/province [389]
0
0
Selangor
Query!
Country [390]
0
0
Malaysia
Query!
State/province [390]
0
0
Sibu
Query!
Country [391]
0
0
Malaysia
Query!
State/province [391]
0
0
Sungai Petani, Kedah
Query!
Country [392]
0
0
Malaysia
Query!
State/province [392]
0
0
Taiping Perak
Query!
Country [393]
0
0
Mexico
Query!
State/province [393]
0
0
Estado De México
Query!
Country [394]
0
0
Mexico
Query!
State/province [394]
0
0
Jalisco
Query!
Country [395]
0
0
Mexico
Query!
State/province [395]
0
0
Michoacán
Query!
Country [396]
0
0
Mexico
Query!
State/province [396]
0
0
Morelos
Query!
Country [397]
0
0
Mexico
Query!
State/province [397]
0
0
Nuevo León
Query!
Country [398]
0
0
Mexico
Query!
State/province [398]
0
0
Sonora
Query!
Country [399]
0
0
Mexico
Query!
State/province [399]
0
0
Aguascalientes
Query!
Country [400]
0
0
Mexico
Query!
State/province [400]
0
0
Chihuahua
Query!
Country [401]
0
0
Mexico
Query!
State/province [401]
0
0
Guadalajara
Query!
Country [402]
0
0
Mexico
Query!
State/province [402]
0
0
Hidalgo
Query!
Country [403]
0
0
Mexico
Query!
State/province [403]
0
0
Merida
Query!
Country [404]
0
0
Mexico
Query!
State/province [404]
0
0
Mexico D.F
Query!
Country [405]
0
0
Mexico
Query!
State/province [405]
0
0
Monterrey
Query!
Country [406]
0
0
Mexico
Query!
State/province [406]
0
0
México DF
Query!
Country [407]
0
0
Mexico
Query!
State/province [407]
0
0
San luis Potosí
Query!
Country [408]
0
0
Netherlands
Query!
State/province [408]
0
0
Alkmaar
Query!
Country [409]
0
0
Netherlands
Query!
State/province [409]
0
0
Almelo
Query!
Country [410]
0
0
Netherlands
Query!
State/province [410]
0
0
Ede Gld
Query!
Country [411]
0
0
Netherlands
Query!
State/province [411]
0
0
Helmond
Query!
Country [412]
0
0
Netherlands
Query!
State/province [412]
0
0
Zutphen
Query!
Country [413]
0
0
Philippines
Query!
State/province [413]
0
0
Alabang, Muntinlupa City
Query!
Country [414]
0
0
Philippines
Query!
State/province [414]
0
0
Caloocan
Query!
Country [415]
0
0
Philippines
Query!
State/province [415]
0
0
Cavite
Query!
Country [416]
0
0
Philippines
Query!
State/province [416]
0
0
Cebu City
Query!
Country [417]
0
0
Philippines
Query!
State/province [417]
0
0
Dasmariñas, Cavite
Query!
Country [418]
0
0
Philippines
Query!
State/province [418]
0
0
Davao
Query!
Country [419]
0
0
Philippines
Query!
State/province [419]
0
0
Iloilo City
Query!
Country [420]
0
0
Philippines
Query!
State/province [420]
0
0
Iloilo
Query!
Country [421]
0
0
Philippines
Query!
State/province [421]
0
0
Jaro, Iloilo City
Query!
Country [422]
0
0
Philippines
Query!
State/province [422]
0
0
Los Banos
Query!
Country [423]
0
0
Philippines
Query!
State/province [423]
0
0
Manila
Query!
Country [424]
0
0
Philippines
Query!
State/province [424]
0
0
Marilao, Bulacan
Query!
Country [425]
0
0
Philippines
Query!
State/province [425]
0
0
Pasay
Query!
Country [426]
0
0
Philippines
Query!
State/province [426]
0
0
Pasig
Query!
Country [427]
0
0
Philippines
Query!
State/province [427]
0
0
Quezon City
Query!
Country [428]
0
0
Philippines
Query!
State/province [428]
0
0
Quezon
Query!
Country [429]
0
0
Philippines
Query!
State/province [429]
0
0
San Fernando, Pampanga
Query!
Country [430]
0
0
Poland
Query!
State/province [430]
0
0
Bialystok
Query!
Country [431]
0
0
Poland
Query!
State/province [431]
0
0
Bielsko-Biala
Query!
Country [432]
0
0
Poland
Query!
State/province [432]
0
0
Bienkowka
Query!
Country [433]
0
0
Poland
Query!
State/province [433]
0
0
Bydgoszcz
Query!
Country [434]
0
0
Poland
Query!
State/province [434]
0
0
Chelmza
Query!
Country [435]
0
0
Poland
Query!
State/province [435]
0
0
Chodziez
Query!
Country [436]
0
0
Poland
Query!
State/province [436]
0
0
Chorzow
Query!
Country [437]
0
0
Poland
Query!
State/province [437]
0
0
Choszczno
Query!
Country [438]
0
0
Poland
Query!
State/province [438]
0
0
Czestochowa
Query!
Country [439]
0
0
Poland
Query!
State/province [439]
0
0
Dabrowa Gornicza
Query!
Country [440]
0
0
Poland
Query!
State/province [440]
0
0
Dzialdowo
Query!
Country [441]
0
0
Poland
Query!
State/province [441]
0
0
Elblag
Query!
Country [442]
0
0
Poland
Query!
State/province [442]
0
0
Gdansk
Query!
Country [443]
0
0
Poland
Query!
State/province [443]
0
0
Gdynia
Query!
Country [444]
0
0
Poland
Query!
State/province [444]
0
0
Gorzow Wielkopolski
Query!
Country [445]
0
0
Poland
Query!
State/province [445]
0
0
Grudziadz
Query!
Country [446]
0
0
Poland
Query!
State/province [446]
0
0
Ilawa
Query!
Country [447]
0
0
Poland
Query!
State/province [447]
0
0
Inowroclaw
Query!
Country [448]
0
0
Poland
Query!
State/province [448]
0
0
Izabelin
Query!
Country [449]
0
0
Poland
Query!
State/province [449]
0
0
Jelenia Gora
Query!
Country [450]
0
0
Poland
Query!
State/province [450]
0
0
Karpacz
Query!
Country [451]
0
0
Poland
Query!
State/province [451]
0
0
Katowice
Query!
Country [452]
0
0
Poland
Query!
State/province [452]
0
0
Kielce
Query!
Country [453]
0
0
Poland
Query!
State/province [453]
0
0
Krakow
Query!
Country [454]
0
0
Poland
Query!
State/province [454]
0
0
Krotoszyn
Query!
Country [455]
0
0
Poland
Query!
State/province [455]
0
0
Ksawerow
Query!
Country [456]
0
0
Poland
Query!
State/province [456]
0
0
Kutno
Query!
Country [457]
0
0
Poland
Query!
State/province [457]
0
0
Libiaz
Query!
Country [458]
0
0
Poland
Query!
State/province [458]
0
0
Lodz
Query!
Country [459]
0
0
Poland
Query!
State/province [459]
0
0
Lublin
Query!
Country [460]
0
0
Poland
Query!
State/province [460]
0
0
Olawa
Query!
Country [461]
0
0
Poland
Query!
State/province [461]
0
0
Olsztyn
Query!
Country [462]
0
0
Poland
Query!
State/province [462]
0
0
Ostrow Wilekopolski
Query!
Country [463]
0
0
Poland
Query!
State/province [463]
0
0
Ostrowiec Swietokrzyski
Query!
Country [464]
0
0
Poland
Query!
State/province [464]
0
0
Piaseczno
Query!
Country [465]
0
0
Poland
Query!
State/province [465]
0
0
Pila
Query!
Country [466]
0
0
Poland
Query!
State/province [466]
0
0
Plock
Query!
Country [467]
0
0
Poland
Query!
State/province [467]
0
0
Police
Query!
Country [468]
0
0
Poland
Query!
State/province [468]
0
0
Poznan
Query!
Country [469]
0
0
Poland
Query!
State/province [469]
0
0
Ruda Slaska
Query!
Country [470]
0
0
Poland
Query!
State/province [470]
0
0
Rudka
Query!
Country [471]
0
0
Poland
Query!
State/province [471]
0
0
Rzeszow
Query!
Country [472]
0
0
Poland
Query!
State/province [472]
0
0
Skarzysko-Kamienna
Query!
Country [473]
0
0
Poland
Query!
State/province [473]
0
0
Skierniewice
Query!
Country [474]
0
0
Poland
Query!
State/province [474]
0
0
Slupsk
Query!
Country [475]
0
0
Poland
Query!
State/province [475]
0
0
Sopot
Query!
Country [476]
0
0
Poland
Query!
State/province [476]
0
0
Swidnik
Query!
Country [477]
0
0
Poland
Query!
State/province [477]
0
0
Szczecin
Query!
Country [478]
0
0
Poland
Query!
State/province [478]
0
0
Tarnow
Query!
Country [479]
0
0
Poland
Query!
State/province [479]
0
0
Tczew
Query!
Country [480]
0
0
Poland
Query!
State/province [480]
0
0
Torun
Query!
Country [481]
0
0
Poland
Query!
State/province [481]
0
0
Warszawa
Query!
Country [482]
0
0
Poland
Query!
State/province [482]
0
0
Wloclawek
Query!
Country [483]
0
0
Poland
Query!
State/province [483]
0
0
Wloszczowa
Query!
Country [484]
0
0
Poland
Query!
State/province [484]
0
0
Wodzislaw Slaski
Query!
Country [485]
0
0
Poland
Query!
State/province [485]
0
0
Wroclaw
Query!
Country [486]
0
0
Poland
Query!
State/province [486]
0
0
Zabrze
Query!
Country [487]
0
0
Poland
Query!
State/province [487]
0
0
Zgierz
Query!
Country [488]
0
0
Poland
Query!
State/province [488]
0
0
Leczyca
Query!
Country [489]
0
0
Romania
Query!
State/province [489]
0
0
Arad
Query!
Country [490]
0
0
Romania
Query!
State/province [490]
0
0
Bacau
Query!
Country [491]
0
0
Romania
Query!
State/province [491]
0
0
Bragadiru
Query!
Country [492]
0
0
Romania
Query!
State/province [492]
0
0
Brasov
Query!
Country [493]
0
0
Romania
Query!
State/province [493]
0
0
Bucarest
Query!
Country [494]
0
0
Romania
Query!
State/province [494]
0
0
Bucharest
Query!
Country [495]
0
0
Romania
Query!
State/province [495]
0
0
Bucuresti
Query!
Country [496]
0
0
Romania
Query!
State/province [496]
0
0
Campulung Muscel
Query!
Country [497]
0
0
Romania
Query!
State/province [497]
0
0
Cluj-Napoca
Query!
Country [498]
0
0
Romania
Query!
State/province [498]
0
0
Codlea
Query!
Country [499]
0
0
Romania
Query!
State/province [499]
0
0
Constanta
Query!
Country [500]
0
0
Romania
Query!
State/province [500]
0
0
Deva
Query!
Country [501]
0
0
Romania
Query!
State/province [501]
0
0
Iasi
Query!
Country [502]
0
0
Romania
Query!
State/province [502]
0
0
Pitesti
Query!
Country [503]
0
0
Romania
Query!
State/province [503]
0
0
Ploiesti
Query!
Country [504]
0
0
Romania
Query!
State/province [504]
0
0
Ramnicu Valcea
Query!
Country [505]
0
0
Romania
Query!
State/province [505]
0
0
Suceava
Query!
Country [506]
0
0
Romania
Query!
State/province [506]
0
0
Targu-Mures
Query!
Country [507]
0
0
Romania
Query!
State/province [507]
0
0
Timisoara
Query!
Country [508]
0
0
Russian Federation
Query!
State/province [508]
0
0
Arkhangelsk
Query!
Country [509]
0
0
Russian Federation
Query!
State/province [509]
0
0
Barnaul
Query!
Country [510]
0
0
Russian Federation
Query!
State/province [510]
0
0
Chelyabinsk
Query!
Country [511]
0
0
Russian Federation
Query!
State/province [511]
0
0
Ekaterinburg
Query!
Country [512]
0
0
Russian Federation
Query!
State/province [512]
0
0
Gatchina
Query!
Country [513]
0
0
Russian Federation
Query!
State/province [513]
0
0
Ivanovo
Query!
Country [514]
0
0
Russian Federation
Query!
State/province [514]
0
0
Izhevsk
Query!
Country [515]
0
0
Russian Federation
Query!
State/province [515]
0
0
Kaliningrad
Query!
Country [516]
0
0
Russian Federation
Query!
State/province [516]
0
0
Kazan
Query!
Country [517]
0
0
Russian Federation
Query!
State/province [517]
0
0
Kemerovo
Query!
Country [518]
0
0
Russian Federation
Query!
State/province [518]
0
0
Kirov
Query!
Country [519]
0
0
Russian Federation
Query!
State/province [519]
0
0
Krasnoyarsk
Query!
Country [520]
0
0
Russian Federation
Query!
State/province [520]
0
0
Kursk
Query!
Country [521]
0
0
Russian Federation
Query!
State/province [521]
0
0
Moscow
Query!
Country [522]
0
0
Russian Federation
Query!
State/province [522]
0
0
Nizhniy Novgorod
Query!
Country [523]
0
0
Russian Federation
Query!
State/province [523]
0
0
Novosibirsk
Query!
Country [524]
0
0
Russian Federation
Query!
State/province [524]
0
0
Orenburg
Query!
Country [525]
0
0
Russian Federation
Query!
State/province [525]
0
0
Perm
Query!
Country [526]
0
0
Russian Federation
Query!
State/province [526]
0
0
Pskov
Query!
Country [527]
0
0
Russian Federation
Query!
State/province [527]
0
0
Rostov-on-Don
Query!
Country [528]
0
0
Russian Federation
Query!
State/province [528]
0
0
Ryazan
Query!
Country [529]
0
0
Russian Federation
Query!
State/province [529]
0
0
Saint Petersburg
Query!
Country [530]
0
0
Russian Federation
Query!
State/province [530]
0
0
Saint-Petersburg
Query!
Country [531]
0
0
Russian Federation
Query!
State/province [531]
0
0
Saratov
Query!
Country [532]
0
0
Russian Federation
Query!
State/province [532]
0
0
Sestroretsk
Query!
Country [533]
0
0
Russian Federation
Query!
State/province [533]
0
0
Smolensk
Query!
Country [534]
0
0
Russian Federation
Query!
State/province [534]
0
0
St Petersburg
Query!
Country [535]
0
0
Russian Federation
Query!
State/province [535]
0
0
St'Petersburg
Query!
Country [536]
0
0
Russian Federation
Query!
State/province [536]
0
0
St-Petersburg
Query!
Country [537]
0
0
Russian Federation
Query!
State/province [537]
0
0
St. Petersburg
Query!
Country [538]
0
0
Russian Federation
Query!
State/province [538]
0
0
St.Petersburg
Query!
Country [539]
0
0
Russian Federation
Query!
State/province [539]
0
0
St.?etersburg
Query!
Country [540]
0
0
Russian Federation
Query!
State/province [540]
0
0
Tomsk
Query!
Country [541]
0
0
Russian Federation
Query!
State/province [541]
0
0
Tver
Query!
Country [542]
0
0
Russian Federation
Query!
State/province [542]
0
0
Ufa
Query!
Country [543]
0
0
Russian Federation
Query!
State/province [543]
0
0
Ulyanovsk
Query!
Country [544]
0
0
Russian Federation
Query!
State/province [544]
0
0
Voronezh
Query!
Country [545]
0
0
Russian Federation
Query!
State/province [545]
0
0
Vsevolzhsk
Query!
Country [546]
0
0
Russian Federation
Query!
State/province [546]
0
0
Yaroslavl
Query!
Country [547]
0
0
Serbia
Query!
State/province [547]
0
0
Belgrade
Query!
Country [548]
0
0
Serbia
Query!
State/province [548]
0
0
Cacak
Query!
Country [549]
0
0
Serbia
Query!
State/province [549]
0
0
Kragujevac
Query!
Country [550]
0
0
Serbia
Query!
State/province [550]
0
0
Nis
Query!
Country [551]
0
0
Serbia
Query!
State/province [551]
0
0
Sombor
Query!
Country [552]
0
0
Serbia
Query!
State/province [552]
0
0
Sremska Kamenica
Query!
Country [553]
0
0
Serbia
Query!
State/province [553]
0
0
Valjevo
Query!
Country [554]
0
0
Slovakia
Query!
State/province [554]
0
0
Bratislava
Query!
Country [555]
0
0
Slovakia
Query!
State/province [555]
0
0
Kosice
Query!
Country [556]
0
0
Slovakia
Query!
State/province [556]
0
0
Kralovsky Chlmec
Query!
Country [557]
0
0
Slovakia
Query!
State/province [557]
0
0
Nove Zamky
Query!
Country [558]
0
0
Slovakia
Query!
State/province [558]
0
0
Presov
Query!
Country [559]
0
0
Slovakia
Query!
State/province [559]
0
0
Spisska Nova Ves
Query!
Country [560]
0
0
Slovakia
Query!
State/province [560]
0
0
Sturovo
Query!
Country [561]
0
0
Slovakia
Query!
State/province [561]
0
0
Trnava
Query!
Country [562]
0
0
Slovakia
Query!
State/province [562]
0
0
Vrable
Query!
Country [563]
0
0
South Africa
Query!
State/province [563]
0
0
Gauteng
Query!
Country [564]
0
0
South Africa
Query!
State/province [564]
0
0
KwaZulu- Natal
Query!
Country [565]
0
0
South Africa
Query!
State/province [565]
0
0
Mpumalanga
Query!
Country [566]
0
0
South Africa
Query!
State/province [566]
0
0
Benoni
Query!
Country [567]
0
0
South Africa
Query!
State/province [567]
0
0
Bloemfontein
Query!
Country [568]
0
0
South Africa
Query!
State/province [568]
0
0
Cape Town
Query!
Country [569]
0
0
South Africa
Query!
State/province [569]
0
0
CapeTown
Query!
Country [570]
0
0
South Africa
Query!
State/province [570]
0
0
Durban
Query!
Country [571]
0
0
South Africa
Query!
State/province [571]
0
0
Gatesville
Query!
Country [572]
0
0
South Africa
Query!
State/province [572]
0
0
Johannesburg
Query!
Country [573]
0
0
South Africa
Query!
State/province [573]
0
0
Korsten
Query!
Country [574]
0
0
South Africa
Query!
State/province [574]
0
0
Lynnwood Ridge
Query!
Country [575]
0
0
South Africa
Query!
State/province [575]
0
0
Mowbray
Query!
Country [576]
0
0
South Africa
Query!
State/province [576]
0
0
Paarl
Query!
Country [577]
0
0
South Africa
Query!
State/province [577]
0
0
Panorama
Query!
Country [578]
0
0
South Africa
Query!
State/province [578]
0
0
Potchefstroom
Query!
Country [579]
0
0
South Africa
Query!
State/province [579]
0
0
Pretoria
Query!
Country [580]
0
0
South Africa
Query!
State/province [580]
0
0
Roodepoort
Query!
Country [581]
0
0
South Africa
Query!
State/province [581]
0
0
Rooihuiskraal
Query!
Country [582]
0
0
South Africa
Query!
State/province [582]
0
0
Somerset West
Query!
Country [583]
0
0
South Africa
Query!
State/province [583]
0
0
Thabazimbi
Query!
Country [584]
0
0
South Africa
Query!
State/province [584]
0
0
Tygerberg
Query!
Country [585]
0
0
South Africa
Query!
State/province [585]
0
0
Voorspoed
Query!
Country [586]
0
0
Spain
Query!
State/province [586]
0
0
Badalona
Query!
Country [587]
0
0
Spain
Query!
State/province [587]
0
0
Barcelona
Query!
Country [588]
0
0
Spain
Query!
State/province [588]
0
0
Benidorm
Query!
Country [589]
0
0
Spain
Query!
State/province [589]
0
0
Canet De Mar - Barcelona
Query!
Country [590]
0
0
Spain
Query!
State/province [590]
0
0
Galdakano
Query!
Country [591]
0
0
Spain
Query!
State/province [591]
0
0
Illescas-Toledo
Query!
Country [592]
0
0
Spain
Query!
State/province [592]
0
0
Jerez de la Frontera
Query!
Country [593]
0
0
Spain
Query!
State/province [593]
0
0
L'Hospitalet de Llobregat
Query!
Country [594]
0
0
Spain
Query!
State/province [594]
0
0
Madrid
Query!
Country [595]
0
0
Spain
Query!
State/province [595]
0
0
Mataró
Query!
Country [596]
0
0
Spain
Query!
State/province [596]
0
0
Oviedo
Query!
Country [597]
0
0
Spain
Query!
State/province [597]
0
0
Palma de Mallorca
Query!
Country [598]
0
0
Spain
Query!
State/province [598]
0
0
Pamplona
Query!
Country [599]
0
0
Spain
Query!
State/province [599]
0
0
Pozuelo De Alarcón/Madrid
Query!
Country [600]
0
0
Spain
Query!
State/province [600]
0
0
Sabadell (Barcelona)
Query!
Country [601]
0
0
Spain
Query!
State/province [601]
0
0
Sagunto/Valencia
Query!
Country [602]
0
0
Spain
Query!
State/province [602]
0
0
Sant Boi de Llobregat
Query!
Country [603]
0
0
Spain
Query!
State/province [603]
0
0
Santa Coloma de Gramenet
Query!
Country [604]
0
0
Spain
Query!
State/province [604]
0
0
Santiago de Compostela
Query!
Country [605]
0
0
Spain
Query!
State/province [605]
0
0
Torrelavega
Query!
Country [606]
0
0
Spain
Query!
State/province [606]
0
0
Valencia
Query!
Country [607]
0
0
Spain
Query!
State/province [607]
0
0
Vic (Barcelona)
Query!
Country [608]
0
0
Taiwan
Query!
State/province [608]
0
0
Changhua
Query!
Country [609]
0
0
Taiwan
Query!
State/province [609]
0
0
Chia-Yi
Query!
Country [610]
0
0
Taiwan
Query!
State/province [610]
0
0
Kaohsiung Hsien
Query!
Country [611]
0
0
Taiwan
Query!
State/province [611]
0
0
Kaohsiung
Query!
Country [612]
0
0
Taiwan
Query!
State/province [612]
0
0
Keelung
Query!
Country [613]
0
0
Taiwan
Query!
State/province [613]
0
0
LinKou
Query!
Country [614]
0
0
Taiwan
Query!
State/province [614]
0
0
Taichung
Query!
Country [615]
0
0
Taiwan
Query!
State/province [615]
0
0
Tainan
Query!
Country [616]
0
0
Taiwan
Query!
State/province [616]
0
0
Taipei
Query!
Country [617]
0
0
Taiwan
Query!
State/province [617]
0
0
Yung Kang City
Query!
Country [618]
0
0
Thailand
Query!
State/province [618]
0
0
Bangkok
Query!
Country [619]
0
0
Thailand
Query!
State/province [619]
0
0
Chiangmai
Query!
Country [620]
0
0
Thailand
Query!
State/province [620]
0
0
Chiangrai
Query!
Country [621]
0
0
Thailand
Query!
State/province [621]
0
0
Khon Kaen
Query!
Country [622]
0
0
Thailand
Query!
State/province [622]
0
0
Mae Rim, Chiang Mai
Query!
Country [623]
0
0
Thailand
Query!
State/province [623]
0
0
Muang Phitsanulok
Query!
Country [624]
0
0
Thailand
Query!
State/province [624]
0
0
Muang
Query!
Country [625]
0
0
Thailand
Query!
State/province [625]
0
0
Nakhon Ratchasima
Query!
Country [626]
0
0
Thailand
Query!
State/province [626]
0
0
Phitsanulok
Query!
Country [627]
0
0
Thailand
Query!
State/province [627]
0
0
Songkla
Query!
Country [628]
0
0
Turkey
Query!
State/province [628]
0
0
Ankara
Query!
Country [629]
0
0
Turkey
Query!
State/province [629]
0
0
Bursa
Query!
Country [630]
0
0
Turkey
Query!
State/province [630]
0
0
Istanbul
Query!
Country [631]
0
0
Turkey
Query!
State/province [631]
0
0
Kocaeli
Query!
Country [632]
0
0
Turkey
Query!
State/province [632]
0
0
Konya
Query!
Country [633]
0
0
Turkey
Query!
State/province [633]
0
0
Samsun
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Country [634]
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Yalta
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Funding & Sponsors
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Name
GlaxoSmithKline
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Summary
Brief summary
The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.
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Trial website
https://clinicaltrials.gov/study/NCT01313676
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Trial related presentations / publications
Horne BD, Hegewald MJ, Crim C, Rea S, Bair TL, Blagev DP. The Summit Score Stratifies Mortality and Morbidity in Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Jul 20;15:1741-1750. doi: 10.2147/COPD.S254437. eCollection 2020. Wise RA, Anderson JA, Amarenco P, Cowans NJ, Crim C, Denvir MA, Gomez CR, Jones MP, Morris A, Niewoehner D, Yates JC. Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial. Clin Trials. 2020 Aug;17(4):430-436. doi: 10.1177/1740774520920897. Epub 2020 May 22. Celli BR, Anderson JA, Brook R, Calverley P, Cowans NJ, Crim C, Dixon I, Kim V, Martinez FJ, Morris A, Newby DE, Yates J, Vestbo J. Serum biomarkers and outcomes in patients with moderate COPD: a substudy of the randomised SUMMIT trial. BMJ Open Respir Res. 2019 May 4;6(1):e000431. doi: 10.1136/bmjresp-2019-000431. eCollection 2019. Fawzy A, Anderson JA, Cowans NJ, Crim C, Wise R, Yates JC, Hansel NN. Association of platelet count with all-cause mortality and risk of cardiovascular and respiratory morbidity in stable COPD. Respir Res. 2019 May 8;20(1):86. doi: 10.1186/s12931-019-1059-1. Vestbo J, Dransfield M, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez F, Newby DE, Yates J, Lange P. Impact of pre-enrolment medication use on clinical outcomes in SUMMIT. ERJ Open Res. 2019 Feb 25;5(1):00203-2018. doi: 10.1183/23120541.00203-2018. eCollection 2019 Feb. Adamson PD, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Dixon IJ, Martinez FJ, Newby DE, Vestbo J, Yates JC, Mills NL. Cardiac Troponin I and Cardiovascular Risk in Patients With Chronic Obstructive Pulmonary Disease. J Am Coll Cardiol. 2018 Sep 4;72(10):1126-1137. doi: 10.1016/j.jacc.2018.06.051. Erratum In: J Am Coll Cardiol. 2018 Oct 30;72(18):2282. doi: 10.1016/j.jacc.2018.09.031. Kunisaki KM, Dransfield MT, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Hartley BF, Martinez FJ, Newby DE, Pragman AA, Vestbo J, Yates JC, Niewoehner DE; SUMMIT Investigators. Exacerbations of Chronic Obstructive Pulmonary Disease and Cardiac Events. A Post Hoc Cohort Analysis from the SUMMIT Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):51-57. doi: 10.1164/rccm.201711-2239OC. Celli B, Anderson JA, Brook R, Calverley P, Crim C, Holmes AP, Martinez FJ, Newby DE, Yates J, Vestbo J; SUMMIT Investigators. Long-Acting beta-Agonist/Inhaled Corticosteroid in Patients with Chronic Obstructive Pulmonary Disease with Cardiovascular Disease or Risk: A Factorial Analysis of the SUMMIT Clinical Trial. Am J Respir Crit Care Med. 2018 Jun 15;197(12):1641-1644. doi: 10.1164/rccm.201710-2052LE. No abstract available. Dransfield MT, McAllister DA, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Gallot N, Martinez FJ, Scanlon PD, Yates J, Vestbo J, Newby DE; SUMMIT Investigators. beta-Blocker Therapy and Clinical Outcomes in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. An Observational Substudy of SUMMIT. Ann Am Thorac Soc. 2018 May;15(5):608-614. doi: 10.1513/AnnalsATS.201708-626OC. Bhatt SP, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez FJ, Newby DE, Vestbo J, Yates JC, Dransfield MT. Cigarette smoking and response to inhaled corticosteroids in COPD. Eur Respir J. 2018 Jan 18;51(1):1701393. doi: 10.1183/13993003.01393-2017. Print 2018 Jan. No abstract available. Crim C, Calverley PMA, Anderson JA, Holmes AP, Kilbride S, Martinez FJ, Brook RD, Newby DE, Yates JC, Celli BR, Vestbo J; SUMMIT investigators. Pneumonia risk with inhaled fluticasone furoate and vilanterol in COPD patients with moderate airflow limitation: The SUMMIT trial. Respir Med. 2017 Oct;131:27-34. doi: 10.1016/j.rmed.2017.07.060. Epub 2017 Aug 1. Calverley PMA, Anderson JA, Brook RD, Crim C, Gallot N, Kilbride S, Martinez FJ, Yates J, Newby DE, Vestbo J, Wise R, Celli BR; SUMMIT (Study to Understand Mortality and Morbidity) Investigators. Fluticasone Furoate, Vilanterol, and Lung Function Decline in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. Am J Respir Crit Care Med. 2018 Jan 1;197(1):47-55. doi: 10.1164/rccm.201610-2086OC. Brook RD, Anderson JA, Calverley PM, Celli BR, Crim C, Denvir MA, Magder S, Martinez FJ, Rajagopalan S, Vestbo J, Yates J, Newby DE; SUMMIT Investigators. Cardiovascular outcomes with an inhaled beta2-agonist/corticosteroid in patients with COPD at high cardiovascular risk. Heart. 2017 Oct;103(19):1536-1542. doi: 10.1136/heartjnl-2016-310897. Epub 2017 Apr 17. Martinez FJ, Vestbo J, Anderson JA, Brook RD, Celli BR, Cowans NJ, Crim C, Dransfield M, Kilbride S, Yates J, Newby DE, Niewoehner D, Calverley PM; SUMMIT Investigators. Effect of Fluticasone Furoate and Vilanterol on Exacerbations of Chronic Obstructive Pulmonary Disease in Patients with Moderate Airflow Obstruction. Am J Respir Crit Care Med. 2017 Apr 1;195(7):881-888. doi: 10.1164/rccm.201607-1421OC. Vestbo J, Anderson JA, Brook RD, Calverley PM, Celli BR, Crim C, Martinez F, Yates J, Newby DE; SUMMIT Investigators. Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): a double-blind randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1817-26. doi: 10.1016/S0140-6736(16)30069-1. Epub 2016 Apr 28. Vestbo J, Anderson J, Brook RD, Calverley PM, Celli BR, Crim C, Haumann B, Martinez FJ, Yates J, Newby DE. The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol. Eur Respir J. 2013 May;41(5):1017-22. doi: 10.1183/09031936.00087312. Epub 2012 Sep 27.
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Public notes
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Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT01313676
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