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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
113782
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/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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From the date of randomization until date of death due to any cause (average of 2 study years)
Secondary outcome [1] 0 0
Decline in Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [1] 0 0
From start date of IP until IP stop date + 1 (assessed up to 4 years)
Secondary outcome [2] 0 0
Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date
Timepoint [2] 0 0
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)

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

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 administering the treatment/s
The people assessing the outcomes
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
25/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/07/2015
Sample size
Target
Accrual to date
Final
16568
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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GSK Investigational Site - Cairns
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GSK Investigational Site - Redcliffe
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GSK Investigational Site - Bedford Park
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GSK Investigational Site - Daw Park
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GSK Investigational Site - Footscray
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GSK Investigational Site - Geelong
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GSK Investigational Site - Melbourne
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GSK Investigational Site - Glen Osmond
Recruitment postcode(s) [1] 0 0
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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5064 - Glen Osmond
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Country [178] 0 0
Croatia
State/province [178] 0 0
Draganic
Country [179] 0 0
Croatia
State/province [179] 0 0
Hrasce Turopoljsko
Country [180] 0 0
Croatia
State/province [180] 0 0
Hreljin
Country [181] 0 0
Croatia
State/province [181] 0 0
Ivankovo
Country [182] 0 0
Croatia
State/province [182] 0 0
Karlovac
Country [183] 0 0
Croatia
State/province [183] 0 0
Klenovnik
Country [184] 0 0
Croatia
State/province [184] 0 0
Krapina
Country [185] 0 0
Croatia
State/province [185] 0 0
Kutina
Country [186] 0 0
Croatia
State/province [186] 0 0
Novi Marof
Country [187] 0 0
Croatia
State/province [187] 0 0
Osijek
Country [188] 0 0
Croatia
State/province [188] 0 0
Retkovci
Country [189] 0 0
Croatia
State/province [189] 0 0
Rijeka
Country [190] 0 0
Croatia
State/province [190] 0 0
Samobor
Country [191] 0 0
Croatia
State/province [191] 0 0
Senj
Country [192] 0 0
Croatia
State/province [192] 0 0
Sibenik
Country [193] 0 0
Croatia
State/province [193] 0 0
Sisak
Country [194] 0 0
Croatia
State/province [194] 0 0
Split
Country [195] 0 0
Croatia
State/province [195] 0 0
Strmec Samoborski
Country [196] 0 0
Croatia
State/province [196] 0 0
Stubicke toplice
Country [197] 0 0
Croatia
State/province [197] 0 0
Sukosan
Country [198] 0 0
Croatia
State/province [198] 0 0
Varazdin
Country [199] 0 0
Croatia
State/province [199] 0 0
Zabok
Country [200] 0 0
Croatia
State/province [200] 0 0
Zadar
Country [201] 0 0
Croatia
State/province [201] 0 0
Zagreb
Country [202] 0 0
Czechia
State/province [202] 0 0
Benesov
Country [203] 0 0
Czechia
State/province [203] 0 0
Beroun
Country [204] 0 0
Czechia
State/province [204] 0 0
Brno
Country [205] 0 0
Czechia
State/province [205] 0 0
Havlickuv brod
Country [206] 0 0
Czechia
State/province [206] 0 0
Hlucin
Country [207] 0 0
Czechia
State/province [207] 0 0
Holesov
Country [208] 0 0
Czechia
State/province [208] 0 0
Jaromer
Country [209] 0 0
Czechia
State/province [209] 0 0
Jindrichuv Hradec
Country [210] 0 0
Czechia
State/province [210] 0 0
Kolin
Country [211] 0 0
Czechia
State/province [211] 0 0
Kralupy nad Vltavou
Country [212] 0 0
Czechia
State/province [212] 0 0
Kromeriz
Country [213] 0 0
Czechia
State/province [213] 0 0
Liberec
Country [214] 0 0
Czechia
State/province [214] 0 0
Melnik
Country [215] 0 0
Czechia
State/province [215] 0 0
Moravsky Krumlov
Country [216] 0 0
Czechia
State/province [216] 0 0
Neratovice
Country [217] 0 0
Czechia
State/province [217] 0 0
Novy Jicin
Country [218] 0 0
Czechia
State/province [218] 0 0
Ostrava - Belsky les
Country [219] 0 0
Czechia
State/province [219] 0 0
Ostrava - Poruba
Country [220] 0 0
Czechia
State/province [220] 0 0
Ostrava
Country [221] 0 0
Czechia
State/province [221] 0 0
Plzen
Country [222] 0 0
Czechia
State/province [222] 0 0
Praha 13
Country [223] 0 0
Czechia
State/province [223] 0 0
Praha 17
Country [224] 0 0
Czechia
State/province [224] 0 0
Praha 1
Country [225] 0 0
Czechia
State/province [225] 0 0
Praha 3
Country [226] 0 0
Czechia
State/province [226] 0 0
Praha 4
Country [227] 0 0
Czechia
State/province [227] 0 0
Praha 5
Country [228] 0 0
Czechia
State/province [228] 0 0
Praha 6
Country [229] 0 0
Czechia
State/province [229] 0 0
Rokycany
Country [230] 0 0
Czechia
State/province [230] 0 0
Rudna
Country [231] 0 0
Czechia
State/province [231] 0 0
Strakonice
Country [232] 0 0
Czechia
State/province [232] 0 0
Svitavy
Country [233] 0 0
Czechia
State/province [233] 0 0
Tremosna
Country [234] 0 0
Czechia
State/province [234] 0 0
Usti Nad Labem - Klise
Country [235] 0 0
Czechia
State/province [235] 0 0
Zatec
Country [236] 0 0
France
State/province [236] 0 0
Ferolles Attilly
Country [237] 0 0
France
State/province [237] 0 0
Paris Cedex 04
Country [238] 0 0
France
State/province [238] 0 0
Strasbourg Cedex
Country [239] 0 0
France
State/province [239] 0 0
Tarbes
Country [240] 0 0
France
State/province [240] 0 0
Toulouse cedex 9
Country [241] 0 0
Georgia
State/province [241] 0 0
Batumi
Country [242] 0 0
Georgia
State/province [242] 0 0
Gurjaani
Country [243] 0 0
Georgia
State/province [243] 0 0
Kutaisi
Country [244] 0 0
Georgia
State/province [244] 0 0
Kvemo Kartli
Country [245] 0 0
Georgia
State/province [245] 0 0
Tbilisi
Country [246] 0 0
Germany
State/province [246] 0 0
Baden-Wuerttemberg
Country [247] 0 0
Germany
State/province [247] 0 0
Bayern
Country [248] 0 0
Germany
State/province [248] 0 0
Brandenburg
Country [249] 0 0
Germany
State/province [249] 0 0
Hessen
Country [250] 0 0
Germany
State/province [250] 0 0
Niedersachsen
Country [251] 0 0
Germany
State/province [251] 0 0
Nordrhein-Westfalen
Country [252] 0 0
Germany
State/province [252] 0 0
Rheinland-Pfalz
Country [253] 0 0
Germany
State/province [253] 0 0
Sachsen-Anhalt
Country [254] 0 0
Germany
State/province [254] 0 0
Sachsen
Country [255] 0 0
Germany
State/province [255] 0 0
Schleswig-Holstein
Country [256] 0 0
Germany
State/province [256] 0 0
Thueringen
Country [257] 0 0
Germany
State/province [257] 0 0
Berlin
Country [258] 0 0
Germany
State/province [258] 0 0
Hamburg
Country [259] 0 0
Germany
State/province [259] 0 0
München
Country [260] 0 0
Greece
State/province [260] 0 0
Athens
Country [261] 0 0
Greece
State/province [261] 0 0
Thessaloniki
Country [262] 0 0
Hungary
State/province [262] 0 0
Balassagyarmat
Country [263] 0 0
Hungary
State/province [263] 0 0
Budapest
Country [264] 0 0
Hungary
State/province [264] 0 0
Debrecen
Country [265] 0 0
Hungary
State/province [265] 0 0
Gyula
Country [266] 0 0
Hungary
State/province [266] 0 0
Kaposvár
Country [267] 0 0
Hungary
State/province [267] 0 0
Komarom
Country [268] 0 0
Hungary
State/province [268] 0 0
Komló
Country [269] 0 0
Hungary
State/province [269] 0 0
Mosonmagyaróvár
Country [270] 0 0
Hungary
State/province [270] 0 0
Nagykanizsa
Country [271] 0 0
Hungary
State/province [271] 0 0
Nyiregyhaza
Country [272] 0 0
Hungary
State/province [272] 0 0
Pécs
Country [273] 0 0
Hungary
State/province [273] 0 0
Sopron
Country [274] 0 0
Hungary
State/province [274] 0 0
Szigetszentmiklos
Country [275] 0 0
Hungary
State/province [275] 0 0
Szikszó
Country [276] 0 0
Hungary
State/province [276] 0 0
Szombathely
Country [277] 0 0
Hungary
State/province [277] 0 0
Tatabanya
Country [278] 0 0
Hungary
State/province [278] 0 0
Vasarosnameny
Country [279] 0 0
Hungary
State/province [279] 0 0
Zalaegerszeg
Country [280] 0 0
India
State/province [280] 0 0
Ahmedabad
Country [281] 0 0
India
State/province [281] 0 0
Alappuzha
Country [282] 0 0
India
State/province [282] 0 0
Angamaly
Country [283] 0 0
India
State/province [283] 0 0
Aurangabad
Country [284] 0 0
India
State/province [284] 0 0
Bangalore
Country [285] 0 0
India
State/province [285] 0 0
Chennai
Country [286] 0 0
India
State/province [286] 0 0
Guntur
Country [287] 0 0
India
State/province [287] 0 0
Hyderabad
Country [288] 0 0
India
State/province [288] 0 0
Jaipur
Country [289] 0 0
India
State/province [289] 0 0
Lucknow
Country [290] 0 0
India
State/province [290] 0 0
Mysore
Country [291] 0 0
India
State/province [291] 0 0
Nagpur
Country [292] 0 0
India
State/province [292] 0 0
Nashik
Country [293] 0 0
India
State/province [293] 0 0
Nasik
Country [294] 0 0
India
State/province [294] 0 0
Pune
Country [295] 0 0
India
State/province [295] 0 0
Trisshur
Country [296] 0 0
India
State/province [296] 0 0
Trivandrum
Country [297] 0 0
India
State/province [297] 0 0
Varanasi
Country [298] 0 0
India
State/province [298] 0 0
Vijayawada
Country [299] 0 0
Indonesia
State/province [299] 0 0
Banda Aceh
Country [300] 0 0
Indonesia
State/province [300] 0 0
Banjarmasin
Country [301] 0 0
Indonesia
State/province [301] 0 0
Bukittinggi
Country [302] 0 0
Indonesia
State/province [302] 0 0
Denpasar
Country [303] 0 0
Indonesia
State/province [303] 0 0
Depok Timur
Country [304] 0 0
Indonesia
State/province [304] 0 0
Jakarta
Country [305] 0 0
Indonesia
State/province [305] 0 0
Lampung Selatan
Country [306] 0 0
Indonesia
State/province [306] 0 0
Makassar
Country [307] 0 0
Indonesia
State/province [307] 0 0
Malang
Country [308] 0 0
Indonesia
State/province [308] 0 0
Medan
Country [309] 0 0
Indonesia
State/province [309] 0 0
Padang
Country [310] 0 0
Indonesia
State/province [310] 0 0
Palembang
Country [311] 0 0
Indonesia
State/province [311] 0 0
Pekanbaru
Country [312] 0 0
Indonesia
State/province [312] 0 0
Pontianak
Country [313] 0 0
Indonesia
State/province [313] 0 0
Pringsewu
Country [314] 0 0
Indonesia
State/province [314] 0 0
Semarang
Country [315] 0 0
Indonesia
State/province [315] 0 0
Surabaya
Country [316] 0 0
Indonesia
State/province [316] 0 0
Surakarta
Country [317] 0 0
Indonesia
State/province [317] 0 0
Yogyakarta
Country [318] 0 0
Israel
State/province [318] 0 0
Afula
Country [319] 0 0
Israel
State/province [319] 0 0
Ashkelon
Country [320] 0 0
Israel
State/province [320] 0 0
Beer-Sheba
Country [321] 0 0
Israel
State/province [321] 0 0
Hadera
Country [322] 0 0
Israel
State/province [322] 0 0
Haifa
Country [323] 0 0
Israel
State/province [323] 0 0
Holon
Country [324] 0 0
Israel
State/province [324] 0 0
Jerusalem
Country [325] 0 0
Israel
State/province [325] 0 0
Kfar Saba
Country [326] 0 0
Israel
State/province [326] 0 0
Rehovot
Country [327] 0 0
Israel
State/province [327] 0 0
Tel Aviv
Country [328] 0 0
Israel
State/province [328] 0 0
Tel Hashomer
Country [329] 0 0
Italy
State/province [329] 0 0
Friuli-Venezia-Giulia
Country [330] 0 0
Japan
State/province [330] 0 0
Aichi
Country [331] 0 0
Japan
State/province [331] 0 0
Fukuoka
Country [332] 0 0
Japan
State/province [332] 0 0
Gifu
Country [333] 0 0
Japan
State/province [333] 0 0
Hokkaido
Country [334] 0 0
Japan
State/province [334] 0 0
Hyogo
Country [335] 0 0
Japan
State/province [335] 0 0
Ibaraki
Country [336] 0 0
Japan
State/province [336] 0 0
Kagawa
Country [337] 0 0
Japan
State/province [337] 0 0
Kodaira
Country [338] 0 0
Japan
State/province [338] 0 0
Kumamoto
Country [339] 0 0
Japan
State/province [339] 0 0
Kyoto
Country [340] 0 0
Japan
State/province [340] 0 0
Oita
Country [341] 0 0
Japan
State/province [341] 0 0
Osaka
Country [342] 0 0
Japan
State/province [342] 0 0
Shimane
Country [343] 0 0
Japan
State/province [343] 0 0
Tokyo
Country [344] 0 0
Korea, Republic of
State/province [344] 0 0
Bucheon-Si, Gyeonggi-Do
Country [345] 0 0
Korea, Republic of
State/province [345] 0 0
Bucheon
Country [346] 0 0
Korea, Republic of
State/province [346] 0 0
Busan
Country [347] 0 0
Korea, Republic of
State/province [347] 0 0
Cheonan
Country [348] 0 0
Korea, Republic of
State/province [348] 0 0
Chonju-si
Country [349] 0 0
Korea, Republic of
State/province [349] 0 0
Daegu
Country [350] 0 0
Korea, Republic of
State/province [350] 0 0
Daejeon
Country [351] 0 0
Korea, Republic of
State/province [351] 0 0
Goyang-si
Country [352] 0 0
Korea, Republic of
State/province [352] 0 0
Guri-si
Country [353] 0 0
Korea, Republic of
State/province [353] 0 0
Gwangju
Country [354] 0 0
Korea, Republic of
State/province [354] 0 0
Gyeonggi-do
Country [355] 0 0
Korea, Republic of
State/province [355] 0 0
Incheon
Country [356] 0 0
Korea, Republic of
State/province [356] 0 0
Kangwon
Country [357] 0 0
Korea, Republic of
State/province [357] 0 0
Seongnam
Country [358] 0 0
Korea, Republic of
State/province [358] 0 0
Seoul
Country [359] 0 0
Korea, Republic of
State/province [359] 0 0
Suwon, Gyeonggi-do
Country [360] 0 0
Korea, Republic of
State/province [360] 0 0
Uijeongbu, Gyeonggi-do
Country [361] 0 0
Korea, Republic of
State/province [361] 0 0
Ulsan
Country [362] 0 0
Korea, Republic of
State/province [362] 0 0
Wonju-si, Kanwon-do
Country [363] 0 0
Latvia
State/province [363] 0 0
Balvi
Country [364] 0 0
Latvia
State/province [364] 0 0
Daugavpils
Country [365] 0 0
Latvia
State/province [365] 0 0
Jekabpils
Country [366] 0 0
Latvia
State/province [366] 0 0
Jelgava
Country [367] 0 0
Latvia
State/province [367] 0 0
Jurmala
Country [368] 0 0
Latvia
State/province [368] 0 0
Kraslava
Country [369] 0 0
Latvia
State/province [369] 0 0
Kuldiga
Country [370] 0 0
Latvia
State/province [370] 0 0
Liepaja
Country [371] 0 0
Latvia
State/province [371] 0 0
Ogre
Country [372] 0 0
Latvia
State/province [372] 0 0
Riga
Country [373] 0 0
Latvia
State/province [373] 0 0
Talsi
Country [374] 0 0
Latvia
State/province [374] 0 0
Tukums
Country [375] 0 0
Latvia
State/province [375] 0 0
Valmiera
Country [376] 0 0
Latvia
State/province [376] 0 0
Ventspils
Country [377] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [377] 0 0
Bitola
Country [378] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [378] 0 0
Gostivar
Country [379] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [379] 0 0
Ohrid
Country [380] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [380] 0 0
Prilep
Country [381] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [381] 0 0
Shtip
Country [382] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [382] 0 0
Skopje
Country [383] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [383] 0 0
Strumica
Country [384] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [384] 0 0
Veles
Country [385] 0 0
Malaysia
State/province [385] 0 0
Johor Bahru
Country [386] 0 0
Malaysia
State/province [386] 0 0
Kuala Lumpur
Country [387] 0 0
Malaysia
State/province [387] 0 0
Kuala Pilah
Country [388] 0 0
Malaysia
State/province [388] 0 0
Kuching
Country [389] 0 0
Malaysia
State/province [389] 0 0
Selangor
Country [390] 0 0
Malaysia
State/province [390] 0 0
Sibu
Country [391] 0 0
Malaysia
State/province [391] 0 0
Sungai Petani, Kedah
Country [392] 0 0
Malaysia
State/province [392] 0 0
Taiping Perak
Country [393] 0 0
Mexico
State/province [393] 0 0
Estado De México
Country [394] 0 0
Mexico
State/province [394] 0 0
Jalisco
Country [395] 0 0
Mexico
State/province [395] 0 0
Michoacán
Country [396] 0 0
Mexico
State/province [396] 0 0
Morelos
Country [397] 0 0
Mexico
State/province [397] 0 0
Nuevo León
Country [398] 0 0
Mexico
State/province [398] 0 0
Sonora
Country [399] 0 0
Mexico
State/province [399] 0 0
Aguascalientes
Country [400] 0 0
Mexico
State/province [400] 0 0
Chihuahua
Country [401] 0 0
Mexico
State/province [401] 0 0
Guadalajara
Country [402] 0 0
Mexico
State/province [402] 0 0
Hidalgo
Country [403] 0 0
Mexico
State/province [403] 0 0
Merida
Country [404] 0 0
Mexico
State/province [404] 0 0
Mexico D.F
Country [405] 0 0
Mexico
State/province [405] 0 0
Monterrey
Country [406] 0 0
Mexico
State/province [406] 0 0
México DF
Country [407] 0 0
Mexico
State/province [407] 0 0
San luis Potosí
Country [408] 0 0
Netherlands
State/province [408] 0 0
Alkmaar
Country [409] 0 0
Netherlands
State/province [409] 0 0
Almelo
Country [410] 0 0
Netherlands
State/province [410] 0 0
Ede Gld
Country [411] 0 0
Netherlands
State/province [411] 0 0
Helmond
Country [412] 0 0
Netherlands
State/province [412] 0 0
Zutphen
Country [413] 0 0
Philippines
State/province [413] 0 0
Alabang, Muntinlupa City
Country [414] 0 0
Philippines
State/province [414] 0 0
Caloocan
Country [415] 0 0
Philippines
State/province [415] 0 0
Cavite
Country [416] 0 0
Philippines
State/province [416] 0 0
Cebu City
Country [417] 0 0
Philippines
State/province [417] 0 0
Dasmariñas, Cavite
Country [418] 0 0
Philippines
State/province [418] 0 0
Davao
Country [419] 0 0
Philippines
State/province [419] 0 0
Iloilo City
Country [420] 0 0
Philippines
State/province [420] 0 0
Iloilo
Country [421] 0 0
Philippines
State/province [421] 0 0
Jaro, Iloilo City
Country [422] 0 0
Philippines
State/province [422] 0 0
Los Banos
Country [423] 0 0
Philippines
State/province [423] 0 0
Manila
Country [424] 0 0
Philippines
State/province [424] 0 0
Marilao, Bulacan
Country [425] 0 0
Philippines
State/province [425] 0 0
Pasay
Country [426] 0 0
Philippines
State/province [426] 0 0
Pasig
Country [427] 0 0
Philippines
State/province [427] 0 0
Quezon City
Country [428] 0 0
Philippines
State/province [428] 0 0
Quezon
Country [429] 0 0
Philippines
State/province [429] 0 0
San Fernando, Pampanga
Country [430] 0 0
Poland
State/province [430] 0 0
Bialystok
Country [431] 0 0
Poland
State/province [431] 0 0
Bielsko-Biala
Country [432] 0 0
Poland
State/province [432] 0 0
Bienkowka
Country [433] 0 0
Poland
State/province [433] 0 0
Bydgoszcz
Country [434] 0 0
Poland
State/province [434] 0 0
Chelmza
Country [435] 0 0
Poland
State/province [435] 0 0
Chodziez
Country [436] 0 0
Poland
State/province [436] 0 0
Chorzow
Country [437] 0 0
Poland
State/province [437] 0 0
Choszczno
Country [438] 0 0
Poland
State/province [438] 0 0
Czestochowa
Country [439] 0 0
Poland
State/province [439] 0 0
Dabrowa Gornicza
Country [440] 0 0
Poland
State/province [440] 0 0
Dzialdowo
Country [441] 0 0
Poland
State/province [441] 0 0
Elblag
Country [442] 0 0
Poland
State/province [442] 0 0
Gdansk
Country [443] 0 0
Poland
State/province [443] 0 0
Gdynia
Country [444] 0 0
Poland
State/province [444] 0 0
Gorzow Wielkopolski
Country [445] 0 0
Poland
State/province [445] 0 0
Grudziadz
Country [446] 0 0
Poland
State/province [446] 0 0
Ilawa
Country [447] 0 0
Poland
State/province [447] 0 0
Inowroclaw
Country [448] 0 0
Poland
State/province [448] 0 0
Izabelin
Country [449] 0 0
Poland
State/province [449] 0 0
Jelenia Gora
Country [450] 0 0
Poland
State/province [450] 0 0
Karpacz
Country [451] 0 0
Poland
State/province [451] 0 0
Katowice
Country [452] 0 0
Poland
State/province [452] 0 0
Kielce
Country [453] 0 0
Poland
State/province [453] 0 0
Krakow
Country [454] 0 0
Poland
State/province [454] 0 0
Krotoszyn
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Hue

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01313676
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01313676