GSK: Protocol Summary for 113782

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Protocol Summary for 113782

Protocol Summary
Protocol Id:	113782
Secondary Ids:
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
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	yes
IND/IDE Grantor:	CDER
IND/IDE Number:	077855
IND/IDE Serial Number:
Has Expanded Access?:	no
Study Type:	Interventional
Oversight Authority:	United States: Food and Drug Administration
Collaborators:
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.
Record Verification Date:	November 2012
Status:	Recruiting
Why Study Stopped:
Study Start Date:	January 2011
Estimated Study Completion Date:	July 2015
Study Completion Date Type:	Anticipated
Estimated Primary Completion Date:	May 2015
Primary Completion Date Type:	Anticipated
Primary Purpose:	treatment
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	yes
Masked Caregiver:	yes
Masked Investigator:	yes
Masked Assessor:	yes
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Efficacy Study
Primary Outcomes:	all cause mortality approx 15 to 44 months
Secondary Outcomes:	FEV1 rate of decline approx 15 to 44 months Time to cardiovascular composite endpoint approx 15 to 44 months
Conditions:	Pulmonary Disease, Chronic Obstructive
Keywords:	COPD Cardiovascular disease Novel Dry Powder Inhaler Survival
Eligibility Criteria:	Click to view inclusion/exclusion 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.
Gender:	Both
Minimum Age:	40 Year
Maximum Age:	80 Year
Enrollment:	16000
Enrollment Type:	Anticipated
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Argentina (click to view all sites in Argentina) GSK Investigational Site Ciudad Autonoma de Buenos Aires, Buenos Aires, C1122AAK; Not Yet Recruiting; Contact: Horacio Budani, Principal Investigator, . GSK Investigational Site Concepcion del Uruguay, Entre Ríos, 3260; Not Yet Recruiting; Contact: Carlos F Victorio, Principal Investigator, . Australia (click to view all sites in Australia) GSK Investigational Site Bedford Park, South Australia, 5042; Recruiting; Contact: Dimitar Sajkov, Principal Investigator, . GSK Investigational Site Daw Park, South Australia, 5041; Not Yet Recruiting; Contact: Huw Davies, Principal Investigator, . GSK Investigational Site Toorak Gardens, South Australia, 5065; Recruiting; Contact: Mon Ming (Michael) Chia, Principal Investigator, . GSK Investigational Site Geelong, Victoria, 3220; Recruiting; Contact: Christopher Steinfort, Principal Investigator, . Austria (click to view all sites in Austria) GSK Investigational Site Thalheim bei Wels, 4600; Recruiting; Contact: Othmar Ablinger, Principal Investigator, . GSK Investigational Site Feldkirch, 6800; Recruiting; Contact: Gerhard Hermann Koeberl, Principal Investigator, . GSK Investigational Site Schluesslberg, 4707; Recruiting; Contact: Peter Wuertz, Principal Investigator, . GSK Investigational Site Linz, A-4020; Recruiting; Contact: Josef Wuertz, Principal Investigator, . GSK Investigational Site Feldbach, 8330; Recruiting; Contact: Robert Voves, Principal Investigator, . Bulgaria (click to view all sites in Bulgaria) GSK Investigational Site Rousse, 7000; Not Yet Recruiting; Contact: Hristo Metev, Principal Investigator, . GSK Investigational Site Sliven, 8800; Not Yet Recruiting; Contact: Christo Terziev, Principal Investigator, . GSK Investigational Site Sofia, 1618; Not Yet Recruiting; Contact: Michael Kyoleyan, Principal Investigator, . GSK Investigational Site Sofia, 1233; Not Yet Recruiting; Contact: Sotir Sotirov, Principal Investigator, . GSK Investigational Site Sofia, 1606; Not Yet Recruiting; Contact: Stoyan Madjarov, Principal Investigator, . GSK Investigational Site Sofia, 1000; Not Yet Recruiting; Contact: Krastyu Penchev, Principal Investigator, . GSK Investigational Site Sofia, 1431; Not Yet Recruiting; Contact: Kiril Palaveev, Principal Investigator, . GSK Investigational Site Dimitrovgrad, 6400; Not Yet Recruiting; Contact: Atanas Mihov, Principal Investigator, . GSK Investigational Site Rousse, 7000; Not Yet Recruiting; Contact: Dimitar Getov, Principal Investigator, . Canada (click to view all sites in Canada) GSK Investigational Site Vancouver, British Columbia, V5Z 4E1; Not Yet Recruiting; Contact: Tharwat A Fera, Principal Investigator, . GSK Investigational Site Sarnia, Ontario, N7T 4X3; Not Yet Recruiting; Contact: Michael F O'Mahony, Principal Investigator, . GSK Investigational Site Burlington, Ontario, L7N 3V2; Not Yet Recruiting; Contact: Patrick Killorn, Principal Investigator, . GSK Investigational Site Sarnia, Ontario, N7T 4X3; Recruiting; Contact: Martyn Chilvers, Principal Investigator, . GSK Investigational Site Orleans, Ontario, K4A 5E6; Not Yet Recruiting; Contact: Shamal Wijay, Principal Investigator, . GSK Investigational Site Mississauga, Ontario, L4T 4J2; Not Yet Recruiting; Contact: Brian Zidel, Principal Investigator, . GSK Investigational Site London, Ontario, N5Y 5K7; Recruiting; Contact: Gordon B Schacter, Principal Investigator, . GSK Investigational Site Toronto, Ontario, M5T 2S8; Not Yet Recruiting; Contact: Kenneth Chapman, Principal Investigator, . GSK Investigational Site Windsor, Ontario, N9A 1C9; Recruiting; Contact: Anil Dhar, Principal Investigator, . GSK Investigational Site Mississauga, Ontario, L5M 2V8; Not Yet Recruiting; Contact: Emad Amer, Principal Investigator, . GSK Investigational Site Grimsby, Ontario, L3M 1P3; Not Yet Recruiting; Contact: Andy Lam, Principal Investigator, . GSK Investigational Site Newmarket, Ontario, L3Y 5G8; Not Yet Recruiting; Contact: Sam Henein, Principal Investigator, . GSK Investigational Site Mirabel, Québec, J7J 2K8; Not Yet Recruiting; Contact: Guy Tellier, Principal Investigator, . Croatia (click to view all sites in Croatia) GSK Investigational Site Zagreb, 10000; Not Yet Recruiting; Contact: Mijo Bergovec, Principal Investigator, . GSK Investigational Site Zagreb, 10000; Recruiting; Contact: Sanja Popovic Grle, Principal Investigator, . GSK Investigational Site Novi Marof, 42220; Recruiting; Contact: Mladen Juraga, Principal Investigator, . GSK Investigational Site Zadar, 23000; Recruiting; Contact: Zeljko Culina, Principal Investigator, . GSK Investigational Site Varazdin, 42000; Recruiting; Contact: Tatjana Cikac, Principal Investigator, . GSK Investigational Site Karlovac, 47000; Not Yet Recruiting; Contact: Davor Horvat, Principal Investigator, . GSK Investigational Site Rijeka, 51000; Recruiting; Contact: Ljiljana Bulat Kardum, Principal Investigator, . GSK Investigational Site Zabok, 49210; Recruiting; Contact: Stjepan Rogan, Principal Investigator, . GSK Investigational Site Zagreb, 10000; Not Yet Recruiting; Contact: Asja S Markovic, Principal Investigator, . GSK Investigational Site Stubicke toplice, 49244; Not Yet Recruiting; Contact: Romano Kurnik, Principal Investigator, . GSK Investigational Site Zagreb, 10000; Recruiting; Contact: Neven Tudorić, Principal Investigator, . GSK Investigational Site Osijek, 31000; Recruiting; Contact: Sanda Skrinjaric Cincar, Principal Investigator, . GSK Investigational Site Klenovnik, 42244; Not Yet Recruiting; Contact: Martina Hajduk, Principal Investigator, . GSK Investigational Site Sisak, 44000; Recruiting; Contact: Ivan Jelic, Principal Investigator, . GSK Investigational Site Zagreb, 10000; Recruiting; Contact: Aleksandar Jovanovic, Principal Investigator, . Czech Republic (click to view all sites in Czech Republic) GSK Investigational Site Praha 1, 110 00; Recruiting; Contact: Elena Gutlerova, Principal Investigator, . GSK Investigational Site Plzen, 323 00; Recruiting; Contact: Andrea Svabkova, Principal Investigator, . GSK Investigational Site Beroun, 266 01; Recruiting; Contact: Ivo Hojka, Principal Investigator, . GSK Investigational Site Svitavy, 568 25; Recruiting; Contact: Milan Kucera, Principal Investigator, . GSK Investigational Site Ostrava - Belsky les, 700 30; Recruiting; Contact: Terezie Janaskova, Principal Investigator, . GSK Investigational Site Novy Jicin, 741 01; Recruiting; Contact: Gustav Ondrejka, Principal Investigator, . GSK Investigational Site Melnik, 276 01; Recruiting; Contact: Jaromir Musil, Principal Investigator, . France (click to view all sites in France) GSK Investigational Site Strasbourg Cedex, 67091; Not Yet Recruiting; Contact: Romain Kessler, Principal Investigator, . GSK Investigational Site Paris Cedex 04, 75181; Not Yet Recruiting; Contact: Nicolas Roche, Principal Investigator, . GSK Investigational Site Tarbes, 65013; Not Yet Recruiting; Contact: Anne Prud'Homme, Principal Investigator, . GSK Investigational Site Toulouse cedex 9, 31059; Not Yet Recruiting; Contact: Roger Escamilla, Principal Investigator, . Germany (click to view all sites in Germany) GSK Investigational Site Bruchsal, Baden-Wuerttemberg, 76646; Recruiting; Contact: Vera Grimm-Sachs, Principal Investigator, . GSK Investigational Site Ettlingen, Baden-Wuerttemberg, 76275; Recruiting; Contact: Wolfgang Gebhardt, Principal Investigator, . GSK Investigational Site Hoechstadt, Bayern, 91315; Recruiting; Contact: Peter Berg, Principal Investigator, . GSK Investigational Site Weissenhorn, Bayern, 89264; Not Yet Recruiting; Contact: Rudolf Remppis, Principal Investigator, . GSK Investigational Site Muenchen, Bayern, 80335; Not Yet Recruiting; Contact: Detlef Mernitz, Principal Investigator, . GSK Investigational Site Augsburg, Bayern, 86150; Recruiting; Contact: Sabina Wehgartner-Winkler, Principal Investigator, . GSK Investigational Site Berlin, Berlin, 10789; Not Yet Recruiting; Contact: Karel Guensberg, Principal Investigator, . GSK Investigational Site Berlin, Berlin, 12043; Not Yet Recruiting; Contact: Rainer Gebhardt, Principal Investigator, . GSK Investigational Site Berlin, Berlin, 12099; Recruiting; Contact: Oliver Noga, Principal Investigator, . GSK Investigational Site Berlin, Berlin, 10969; Recruiting; Contact: Ulrike Westerhausen, Principal Investigator, . GSK Investigational Site Berlin, Berlin, 13507; Recruiting; Contact: Harald Sudhoff, Principal Investigator, . GSK Investigational Site Berlin, Berlin, 13086; Recruiting; Contact: Andreas Benedix, Principal Investigator, . GSK Investigational Site Marburg, Hessen, 35037; Recruiting; Contact: Hermann A Trauth, Principal Investigator, . GSK Investigational Site Marburg, Hessen, 35037; Recruiting; Contact: Wolfgang Schuermann, Principal Investigator, . GSK Investigational Site Kassel, Hessen, 34121; Recruiting; Contact: Wolfram Feussner, Principal Investigator, . GSK Investigational Site Hannover, Niedersachsen, 30159; Recruiting; Contact: Veronika Richter, Principal Investigator, . GSK Investigational Site Gelsenkirchen, Nordrhein-Westfalen, 45879; Recruiting; Contact: Ludger Lindemann, Principal Investigator, . GSK Investigational Site Essen, Nordrhein-Westfalen, 45355; Recruiting; Contact: Axel Schaefer, Principal Investigator, . GSK Investigational Site Harsewinkel, Nordrhein-Westfalen, 33428; Not Yet Recruiting; Contact: Uwe Horstmeier, Principal Investigator, . GSK Investigational Site Bergisch Gladbach, Nordrhein-Westfalen, 51429; Recruiting; Contact: Gerd-Ulrich Heinz, Principal Investigator, . GSK Investigational Site Bonn, Nordrhein-Westfalen, 53119; Recruiting; Contact: Thomas Ginko, Principal Investigator, . GSK Investigational Site Solingen, Nordrhein-Westfalen, 42651; Not Yet Recruiting; Contact: Ulrich Botzen, Principal Investigator, . GSK Investigational Site Dortmund, Nordrhein-Westfalen, 44263; Recruiting; Contact: Berthold Butsch-von der Heydt, Principal Investigator, . GSK Investigational Site Foehren, Rheinland-Pfalz, 54343; Recruiting; Contact: Christof Welss, Principal Investigator, . GSK Investigational Site Dresden, Sachsen, 01307; Not Yet Recruiting; Contact: Juergen Wurziger, Principal Investigator, . GSK Investigational Site Riesa, Sachsen, 01587; Recruiting; Contact: Tasso Bieler, Principal Investigator, . GSK Investigational Site Leipzig, Sachsen, 04275; Recruiting; Contact: Gerhard Hoheisel, Principal Investigator, . GSK Investigational Site Leipzig, Sachsen, 04357; Recruiting; Contact: Christian Gessner, Principal Investigator, . GSK Investigational Site Reinfeld, Schleswig-Holstein, 23858; Recruiting; Contact: Joachim Weimer, Principal Investigator, . GSK Investigational Site Jena, Thueringen, 07747; Recruiting; Contact: Claus Kroegel, Principal Investigator, . Hungary (click to view all sites in Hungary) GSK Investigational Site Nagykanizsa, 08800; Not Yet Recruiting; Contact: Zsolt Andrasofszky, Principal Investigator, . GSK Investigational Site Szikszó, 3800; Not Yet Recruiting; Contact: Imre Szentpéteri, Principal Investigator, . Italy (click to view all sites in Italy) GSK Investigational Site Pordenone, Friuli-Venezia-Giulia, 33170; Not Yet Recruiting; Contact: Francesco Mazza, Principal Investigator, .

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Protocol Summary for 113782