Clinical trial NCT01313676: Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Cardiovascular disease
Novel Dry Powder Inhaler
Survival
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 16568
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Despite a potential link between the pathogenetic mechanisms involved in Chronic Obstructive Pulmonary Disease (COPD) and atherosclerotic cardiovascular disease, there are no currently approved therapies for patients with COPD that have clearly shown an additional beneficial effect in patients with cardiovascular comorbidities. The TOwards a Revolution in COPD Health (TORCH) study assessed the impact of the inhaled corticosteroid (ICS) fluticasone propionate (FP) in combination with the long-acting beta agonist (LABA), salmeterol (SAL), in reducing all-cause mortality. TORCH demonstrated a 17.5% reduction on all-cause mortality with salmeterol-fluticasone propionate combination (SFC) compared with placebo (HR=0.825, 95% CI (0.681, 1.002), p=0.052) in the entire COPD population with disease severity form moderate to very severe. A post hoc analysis of the data restricted to those subjects with an forced expiratory volume in 1 second (FEV1) \>=50% predicted with an apparent history of cardiovascular co-morbidities (defined as use at baseline of beta-blockers, angiotensin converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB), HMG CoA reductase inhibitors (i.e. statins) or a prior MI recorded at baseline) demonstrated a 49% reduction in the risk of dying within 96 weeks for the comparison of SFC with placebo. These post hoc data suggest the possibility of an ICS/LABA combination product to be of substantial benefit in COPD subjects with less severe airflow obstruction yet with increased cardiovascular risk.

The mechanism by which SFC appears to be associated with a greater reduction in mortality in these less severe COPD subjects with concomitant cardiovascular comorbidities is speculative at present, but could potentially in part be related to a lessening of the degree of inflammation in the systemic circulation, potential plaque stabilization and/or amelioration of arterial stiffness.

ICS/LABA combinations that are currently available require twice daily administration. A once daily ICS/LABA combination has the potential to improve patient compliance and as a result, overall disease management.

The purpose of this study is to prospectively evaluate the effect of the once daily ICS/LABA combination Fluticasone Furoate (FF)/Vilanterol (VI) on survival in subjects with moderate COPD (\>=50 and =\<70 % predicted FEV1 ) and a history of, or at increased risk for cardiovascular disease.

Eligibility criteria: 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

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.

Primary outcomes:
measure: 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
timeFrame: From the date of randomization until date of death due to any cause (average of 2 study years)
Secondary outcomes:
measure: Decline in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: From start date of IP until IP stop date + 1 (assessed up to 4 years)
measure: Number of Participants With First On-treatment Cardiovascular (CV) Composite Events Occured on or Before Common End Date
timeFrame: 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)
Other outcomes:
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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state: North Carolina
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state: Córdova
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Zwettl
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Neuwied
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Rhaunen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Zerbst
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Goerlitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Riesa
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Reinfeld
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Schleswig
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Jena
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: München
country: Germany
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Balassagyarmat
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Debrecen
country: Hungary
facility: GSK Investigational Site
city: Debrecen
country: Hungary
facility: GSK Investigational Site
city: Gyula
country: Hungary
facility: GSK Investigational Site
city: Kaposvár
country: Hungary
facility: GSK Investigational Site
city: Komarom
country: Hungary
facility: GSK Investigational Site
city: Komló
country: Hungary
facility: GSK Investigational Site
city: Mosonmagyaróvár
country: Hungary
facility: GSK Investigational Site
city: Nagykanizsa
country: Hungary
facility: GSK Investigational Site
city: Nyiregyhaza
country: Hungary
facility: GSK Investigational Site
city: Pécs
country: Hungary
facility: GSK Investigational Site
city: Sopron
country: Hungary
facility: GSK Investigational Site
city: Szigetszentmiklos
country: Hungary
facility: GSK Investigational Site
city: Szikszó
country: Hungary
facility: GSK Investigational Site
city: Szombathely
country: Hungary
facility: GSK Investigational Site
city: Tatabanya
country: Hungary
facility: GSK Investigational Site
city: Vasarosnameny
country: Hungary
facility: GSK Investigational Site
city: Zalaegerszeg
country: Hungary
facility: GSK Investigational Site
city: Ahmedabad
country: India
facility: GSK Investigational Site
city: Ahmedabad
country: India
facility: GSK Investigational Site
city: Alappuzha
country: India
facility: GSK Investigational Site
city: Angamaly
country: India
facility: GSK Investigational Site
city: Aurangabad
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Chennai
country: India
facility: GSK Investigational Site
city: Chennai
country: India
facility: GSK Investigational Site
city: Guntur
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Lucknow
country: India
facility: GSK Investigational Site
city: Mysore
country: India
facility: GSK Investigational Site
city: Mysore
country: India
facility: GSK Investigational Site
city: Nagpur
country: India
facility: GSK Investigational Site
city: Nagpur
country: India
facility: GSK Investigational Site
city: Nashik
country: India
facility: GSK Investigational Site
city: Nasik
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Trisshur
country: India
facility: GSK Investigational Site
city: Trivandrum
country: India
facility: GSK Investigational Site
city: Varanasi
country: India
facility: GSK Investigational Site
city: Varanasi
country: India
facility: GSK Investigational Site
city: Vijayawada
country: India
facility: GSK Investigational Site
city: Banda Aceh
country: Indonesia
facility: GSK Investigational Site
city: Banjarmasin
country: Indonesia
facility: GSK Investigational Site
city: Bukittinggi
country: Indonesia
facility: GSK Investigational Site
city: Denpasar
country: Indonesia
facility: GSK Investigational Site
city: Depok Timur
country: Indonesia
facility: GSK Investigational Site
city: Jakarta
country: Indonesia
facility: GSK Investigational Site
city: Jakarta
country: Indonesia
facility: GSK Investigational Site
city: Jakarta
country: Indonesia
facility: GSK Investigational Site
city: Lampung Selatan
country: Indonesia
facility: GSK Investigational Site
city: Makassar
country: Indonesia
facility: GSK Investigational Site
city: Malang
country: Indonesia
facility: GSK Investigational Site
city: Medan
country: Indonesia
facility: GSK Investigational Site
city: Medan
country: Indonesia
facility: GSK Investigational Site
city: Padang
country: Indonesia
facility: GSK Investigational Site
city: Palembang
country: Indonesia
facility: GSK Investigational Site
city: Pekanbaru
country: Indonesia
facility: GSK Investigational Site
city: Pontianak
country: Indonesia
facility: GSK Investigational Site
city: Pringsewu
country: Indonesia
facility: GSK Investigational Site
city: Semarang
country: Indonesia
facility: GSK Investigational Site
city: Surabaya
country: Indonesia
facility: GSK Investigational Site
city: Surakarta
country: Indonesia
facility: GSK Investigational Site
city: Yogyakarta
country: Indonesia
facility: GSK Investigational Site
city: Afula
country: Israel
facility: GSK Investigational Site
city: Ashkelon
country: Israel
facility: GSK Investigational Site
city: Beer-Sheba
country: Israel
facility: GSK Investigational Site
city: Hadera
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Holon
country: Israel
facility: GSK Investigational Site
city: Jerusalem
country: Israel
facility: GSK Investigational Site
city: Kfar Saba
country: Israel
facility: GSK Investigational Site
city: Rehovot
country: Israel
facility: GSK Investigational Site
city: Tel Aviv
country: Israel
facility: GSK Investigational Site
city: Tel Hashomer
country: Israel
facility: GSK Investigational Site
city: Pordenone
country: Italy
facility: GSK Investigational Site
state: Friuli-Venezia-Giulia
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Gifu
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hyogo
country: Japan
facility: GSK Investigational Site
city: Ibaraki
country: Japan
facility: GSK Investigational Site
city: Kagawa
country: Japan
facility: GSK Investigational Site
city: Kodaira
country: Japan
facility: GSK Investigational Site
city: Kumamoto
country: Japan
facility: GSK Investigational Site
city: Kyoto
country: Japan
facility: GSK Investigational Site
city: Oita
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Shimane
country: Japan
facility: GSK Investigational Site
city: Shimane
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Bucheon-Si, Gyeonggi-Do
country: Korea, Republic of
facility: GSK Investigational Site
city: Bucheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Cheonan
country: Korea, Republic of
facility: GSK Investigational Site
city: Chonju-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Daejeon
country: Korea, Republic of
facility: GSK Investigational Site
city: Daejeon
country: Korea, Republic of
facility: GSK Investigational Site
city: Goyang-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Guri-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Gwangju
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Kangwon
country: Korea, Republic of
facility: GSK Investigational Site
city: Seongnam
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Suwon, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Uijeongbu, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Ulsan
country: Korea, Republic of
facility: GSK Investigational Site
city: Wonju-si, Kanwon-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Balvi
country: Latvia
facility: GSK Investigational Site
city: Daugavpils
country: Latvia
facility: GSK Investigational Site
city: Daugavpils
country: Latvia
facility: GSK Investigational Site
city: Jekabpils
country: Latvia
facility: GSK Investigational Site
city: Jelgava
country: Latvia
facility: GSK Investigational Site
city: Jurmala
country: Latvia
facility: GSK Investigational Site
city: Kraslava
country: Latvia
facility: GSK Investigational Site
city: Kuldiga
country: Latvia
facility: GSK Investigational Site
city: Liepaja
country: Latvia
facility: GSK Investigational Site
city: Ogre
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Talsi
country: Latvia
facility: GSK Investigational Site
city: Tukums
country: Latvia
facility: GSK Investigational Site
city: Valmiera
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facility: GSK Investigational Site
city: Ventspils
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facility: GSK Investigational Site
city: Bitola
country: Macedonia, The Former Yugoslav Republic of
facility: GSK Investigational Site
city: Gostivar
country: Macedonia, The Former Yugoslav Republic of
facility: GSK Investigational Site
city: Ohrid
country: Macedonia, The Former Yugoslav Republic of
facility: GSK Investigational Site
city: Prilep
country: Macedonia, The Former Yugoslav Republic of
facility: GSK Investigational Site
city: Shtip
country: Macedonia, The Former Yugoslav Republic of
facility: GSK Investigational Site
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: GSK Investigational Site
city: Strumica
country: Macedonia, The Former Yugoslav Republic of
facility: GSK Investigational Site
city: Veles
country: Macedonia, The Former Yugoslav Republic of
facility: GSK Investigational Site
city: Johor Bahru
country: Malaysia
facility: GSK Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: GSK Investigational Site
city: Kuala Pilah
country: Malaysia
facility: GSK Investigational Site
city: Kuching
country: Malaysia
facility: GSK Investigational Site
city: Selangor
country: Malaysia
facility: GSK Investigational Site
city: Sibu
country: Malaysia
facility: GSK Investigational Site
city: Sungai Petani, Kedah
country: Malaysia
facility: GSK Investigational Site
city: Taiping Perak
country: Malaysia
facility: GSK Investigational Site
city: Cuautitlan Izcalli
country: Mexico
facility: GSK Investigational Site
state: Estado De México
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Zapopan
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Morelia
country: Mexico
facility: GSK Investigational Site
state: Michoacán
city: Cuernavaca
country: Mexico
facility: GSK Investigational Site
state: Morelos
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Hermosillo
country: Mexico
facility: GSK Investigational Site
state: Sonora
city: Aguascalientes
country: Mexico
facility: GSK Investigational Site
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
city: Hidalgo
country: Mexico
facility: GSK Investigational Site
city: Merida
country: Mexico
facility: GSK Investigational Site
city: Mexico D.F
country: Mexico
facility: GSK Investigational Site
city: Monterrey
country: Mexico
facility: GSK Investigational Site
city: México DF
country: Mexico
facility: GSK Investigational Site
city: San luis Potosí
country: Mexico
facility: GSK Investigational Site
city: Alkmaar
country: Netherlands
facility: GSK Investigational Site
city: Almelo
country: Netherlands
facility: GSK Investigational Site
city: Ede Gld
country: Netherlands
facility: GSK Investigational Site
city: Helmond
country: Netherlands
facility: GSK Investigational Site
city: Zutphen
country: Netherlands
facility: GSK Investigational Site
city: Alabang, Muntinlupa City
country: Philippines
facility: GSK Investigational Site
city: Caloocan
country: Philippines
facility: GSK Investigational Site
city: Cavite
country: Philippines
facility: GSK Investigational Site
city: Cebu City
country: Philippines
facility: GSK Investigational Site
city: Dasmariñas, Cavite
country: Philippines
facility: GSK Investigational Site
city: Davao
country: Philippines
facility: GSK Investigational Site
city: Iloilo City
country: Philippines
facility: GSK Investigational Site
city: Iloilo
country: Philippines
facility: GSK Investigational Site
city: Jaro, Iloilo City
country: Philippines
facility: GSK Investigational Site
city: Los Banos
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Marilao, Bulacan
country: Philippines
facility: GSK Investigational Site
city: Pasay
country: Philippines
facility: GSK Investigational Site
city: Pasig
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon
country: Philippines
facility: GSK Investigational Site
city: San Fernando, Pampanga
country: Philippines
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bielsko-Biala
country: Poland
facility: GSK Investigational Site
city: Bielsko-Biala
country: Poland
facility: GSK Investigational Site
city: Bienkowka
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Chelmza
country: Poland
facility: GSK Investigational Site
city: Chodziez
country: Poland
facility: GSK Investigational Site
city: Chorzow
country: Poland
facility: GSK Investigational Site
city: Choszczno
country: Poland
facility: GSK Investigational Site
city: Czestochowa
country: Poland
facility: GSK Investigational Site
city: Dabrowa Gornicza
country: Poland
facility: GSK Investigational Site
city: Dzialdowo
country: Poland
facility: GSK Investigational Site
city: Elblag
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gdynia
country: Poland
facility: GSK Investigational Site
city: Gorzow Wielkopolski
country: Poland
facility: GSK Investigational Site
city: Grudziadz
country: Poland
facility: GSK Investigational Site
city: Ilawa
country: Poland
facility: GSK Investigational Site
city: Inowroclaw
country: Poland
facility: GSK Investigational Site
city: Izabelin
country: Poland
facility: GSK Investigational Site
city: Jelenia Gora
country: Poland
facility: GSK Investigational Site
city: Karpacz
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Kielce
country: Poland
facility: GSK Investigational Site
city: Kielce
country: Poland
facility: GSK Investigational Site
city: Kielce
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krotoszyn
country: Poland
facility: GSK Investigational Site
city: Ksawerow
country: Poland
facility: GSK Investigational Site
city: Kutno
country: Poland
facility: GSK Investigational Site
city: Libiaz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lublin
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facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Olawa
country: Poland
facility: GSK Investigational Site
city: Olsztyn
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facility: GSK Investigational Site
city: Ostrow Wilekopolski
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facility: GSK Investigational Site
city: Ostrowiec Swietokrzyski
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facility: GSK Investigational Site
city: Piaseczno
country: Poland
facility: GSK Investigational Site
city: Pila
country: Poland
facility: GSK Investigational Site
city: Plock
country: Poland
facility: GSK Investigational Site
city: Police
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Ruda Slaska
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facility: GSK Investigational Site
city: Rudka
country: Poland
facility: GSK Investigational Site
city: Rzeszow
country: Poland
facility: GSK Investigational Site
city: Skarzysko-Kamienna
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facility: GSK Investigational Site
city: Skierniewice
country: Poland
facility: GSK Investigational Site
city: Slupsk
country: Poland
facility: GSK Investigational Site
city: Sopot
country: Poland
facility: GSK Investigational Site
city: Swidnik
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facility: GSK Investigational Site
city: Szczecin
country: Poland
facility: GSK Investigational Site
city: Szczecin
country: Poland
facility: GSK Investigational Site
city: Tarnow
country: Poland
facility: GSK Investigational Site
city: Tczew
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wloclawek
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facility: GSK Investigational Site
city: Wloszczowa
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facility: GSK Investigational Site
city: Wodzislaw Slaski
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facility: GSK Investigational Site
city: Wroclaw
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facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Zabrze
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facility: GSK Investigational Site
city: Zabrze
country: Poland
facility: GSK Investigational Site
city: Zgierz
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facility: GSK Investigational Site
city: Łęczyca
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facility: GSK Investigational Site
city: Arad
country: Romania
facility: GSK Investigational Site
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country: Romania
facility: GSK Investigational Site
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country: Romania
facility: GSK Investigational Site
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country: Romania
facility: GSK Investigational Site
city: Brasov
country: Romania
facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Changhua
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Milton Keynes
country: United Kingdom
facility: GSK Investigational Site
city: Reading
country: United Kingdom
facility: GSK Investigational Site
city: Sidcup, Kent
country: United Kingdom
facility: GSK Investigational Site
city: Tyne And Wear
country: United Kingdom
facility: GSK Investigational Site
city: Can Tho
country: Vietnam
facility: GSK Investigational Site
city: Ha Noi
country: Vietnam
facility: GSK Investigational Site
city: Ho Chi Minh
country: Vietnam
facility: GSK Investigational Site
city: Hue
country: Vietnam
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.