GSK: Protocol Summary for FFA109684

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Protocol Summary for FFA109684

Protocol Summary
Protocol Id:	FFA109684
Secondary Ids:
Title:	A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 500mcg Twice Daily compared with Placebo for 8 Weeks in Adolescent an
Phase:	phase 2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	yes
IND/IDE Grantor:	CDER
IND/IDE Number:	70,297
IND/IDE Serial Number:	0012
Has Expanded Access?:
Study Type:	Interventional
Oversight Authority:	United States: Food and Drug Administration.
Collaborators:
Brief Summary:	This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.
Detailed Description:	A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Moderate-Dose ICS Therapy
Record Verification Date:
Status:	Completed
Why Study Stopped:
Study Start Date:	December 2007
Study Completion Date:	September 2008
Study Completion Date Type:	Actual
Primary Completion Date:	September 2008
Primary Completion Date Type:	Actual
Primary Purpose:	treatment
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	false
Masked Caregiver:	false
Masked Investigator:	false
Masked Assessor:	false
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	Mean change from baseline to the end of the 8-week treatment period (last assessment on treatment using last observation carried forward) in trough (pre-dose and pre- rescue bronchodilator) FEV1.
Secondary Outcomes:	- Mean change from baseline in: -daily trough PEF. -daily AM PEF. -the percentage of symptom-free 24 hour periods. -the percentage of rescue-free 24 hour periods. - The number of withdrawals due to lack of efficacy. Mean change from baseline in daily trough (pre-dose and pre-rescue bronchodilator) PM PEF averaged over the 8-week treatment period. Mean change from baseline in daily AM PEF averaged over the 8-week treatment period. Mean change from baseline in the percentage of symptom-free 24 hour periods during the 8-week treatment period. The number of withdrawals due to lack of efficacy during the 8-week treatment period. Incidence of adverse events throughout the 8-week treatment period; Examination of the oropharynx at Clinic Visit 1 and Clinic Visits 3 through 8 for evidence of oral candidiasis; Hematology, clinical chemistry, and urinalysis parameters before and at the end of the 8-week treatment period; 24-hr urinary cortisol excretion assessment before and at the end of the 8-week treatment period; Vital signs (including pulse and blood pressure) at Clinic Visit 1 and Clinic Visits 3 through 8.
Conditions:	Asthma
Keywords:	Asthma GW685698X Adolescents Adults Pharmacokinetics Pharmacogenetics
Eligibility Criteria:	Click to view inclusion/exclusion criteria INCLUSION CRITERIA: Subjects eligible for enrolment in the study must meet all of the following criteria: •Type of Subject: Outpatient •Age: 12 years of age or older at Visit 1. For sites in the following countries, subjects recruited will be ≥18 years of age: Bulgaria, Czech Republic, Germany, Greece, Lithuania, New Zealand, Russian Federation, Turkey and any other countries where local regulations or the regulatory status of study medication permit enrolment of adults only. •3. Gender: Male or Eligible Female -To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following: -Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject -Implants of levonorgestrel -Injectable progestogen -Oral contraceptive (either combined estrogen/progestin or progestin only) -Any intrauterine device (IUD) with a documented failure rate of less than 1% per year. -Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse throughout the clinical trial and for a period after the trial to account for elimination of the drug (minimum of six days). -Double barrier method • spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm). -NB: For German sites, female subjects must use a method of birth control other than the double barrier method. -The contraceptive transdermal patch, Ortho Evra (if the subject is less than 198 pounds) -Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. A serum pregnancy test is required of all females. This test will be performed at the initial screening visit (Visit 1) and Visit 8. In addition, a urine pregnancy test will be performed on the evening of the double-blind treatment visit, prior to randomization (Visit 3) and at Visits 4 through 7. •Asthma Diagnosis: Asthma as defined by the National Institutes of Health [National Institutes of Health, 2007]. •Severity of Disease: A best FEV1 of 40%-85% of the predicted normal value during the morning Visit 1 screening period or a best FEV1 of 40%-90% of the predicted normal value during the evening Visit 1 screening period. •Reversibility of Disease: Demonstrated a ≥ 12% and ≥200mL reversibility of FEV1 within approximately 30-minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) or one nebulized albuterol/salbutamol solution during the screening period. Re-screening of subjects during the Visit 1 screening period: If a subject does not meet the inclusion criteria based upon FEV1 percent predicted and/or reversibility, the subject may return to the site once within 4 days and repeat the lung function tests. •Current Anti-Asthma Therapy: Subjects must have been using a inhaled corticosteroid for at least 8 weeks prior to Visit 1 and maintained on a stable dose of inhaled corticosteroids for four weeks prior to Visit 1 at one of the following doses: [fluticasone propionate MDI CFC/HFA >176 ≤ 440mcg exactuator or > 200 ≤500mcg ex valve]; [fluticasone propionate DPI > 200≤500mcg]; [beclomethasone dipropionate DPI > 420 ≤ 840mcg exactuator or > 500 ≤ 1000mcg ex-valve]; [beclomethasone dipropionate HFA Qvar > 160 ≤ 480mcg exactuator or > 200 ≤ 500mcg ex-valve]; [budesonide DPI MDI >400 ≤1200mcg]; [flunisolide > 1000 ≤ 2000mcg]; [triamcinolone acetonide >1000 ≤1600mcg]; [mometasone furoate DPI >200 ≤ 440mcg]; [ciclesonide MDI HFA >160 mcg ≤ 320mcg ex-actuator dose / >200mcg ≤ 400mcg ex-valve dose} •Short • Acting Beta2-Agonists: All subjects must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhalation aerosol at Visit 1 for use as needed for the duration of the study. The use of spacer devices with metered dose inhaler (MDI) or nebulized albuterol/salbutamol will not be allowed during the study with the exception of their use during reversibility testing at Visit 1. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to all study visits. •Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study. •Compliance: Subjects must be able to comply with completion of the Daily Diary (includes paper medical conditions diary). •French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Inclusion Criteria for Randomization At the end of the run-in period, a subject will be eligible to enter the treatment period of the study if he/she meets the following criteria at Visit 3: 1.Evening pre-dose percent predicted FEV1 of between 40% and 90% of their predicted normal. 2.Any combination of the daily asthma symptom scores (day-time plus night-time) of ≥1 or albuterol/salbutamol use on at least 4 of the last 7 consecutive days of the run-in period (immediately preceding Visit 3). EXCLUSION CRITERIA: •History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures. •Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subject's asthma status or the subject's ability to participate in the study. •Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 3 months of Visit 1. A subject must not have had any hospitalization for asthma within 6 months prior to Visit 1. •Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease including, but not limited to: cardiovascular disease, hepatic disease, renal disease, hematological disease, neurological disease, or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. The list of additional excluded conditions/diseases includes, but is not limited to the following: congestive heart failure, clinically significant coronary artery disease, stroke within 3 months of Visit 1, poorly controlled peptic ulcer, immunologic compromise, tuberculosis (current or untreated), Addison's disease, uncontrolled thyroid disorder, known aortic aneurysm, clinically significant cardiac arrhythmia, uncontrolled hypertension, hematological, hepatic, or renal disease, current malignancy, cushings disease, uncontrolled diabetes mellitus, recent history of drug or alcohol abuse. •Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of oral candidiasis at Visit 1. •Investigational Medications: A subject must not have participated in a study or used any investigational drug within 30 days prior to Visit 1. •Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the novel dry powder inhaler or DISKUS/ACCUHALER (i.e., lactose or magnesium stearate). •Milk Protein Allergy: History of severe milk protein allergy. •Immunosuppressive Medications: A subject must not be using, or require use, of immunosuppressive medications during the study. NOTE: Immunotherapy for the treatment of allergies is allowed during the study provided that the treatment was initiated prior to Visit 1 and the subject is maintained on a stable regimen throughout the study period. •Attendance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol or scheduled visits to the study center and non-compliant with study medication or procedures (e.g. completion of daily diary). Neurological or psychiatric disease or history of drug or alcohol abuse which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements excludes study participation. •Tobacco Use : Current smoker or a smoking history of 10 pack years or more (e.g. 20 cigarettes/day for 10 years). A subject may not have used tobacco products within the past one year (i.e., cigarettes, cigars, or pipe tobacco). •Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub‑Investigator, study coordinator, or employee of the participating Investigator. •Corticosteroid Use: Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1. •Potent Cytochrome P450 3A4 (CYP3A4) inhibitors: Patients who are receiving potent CYP3A4 inhibitors within 4 weeks of Visit 1 (e.g., ritonavir, ketoconazole, itraconazole). Exclusion Criteria for Randomization At the end of the run-in period, a subject will not be eligible to enter the treatment period of the study if they meet any of the following criteria. 1.Clinical Laboratory Abnormalities: Clinically significant abnormal laboratory tests during Visit 1 which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality. When in doubt, GlaxoSmithKline, or designee, should be notified so that a joint decision can be made. 2.Changes in asthma medication (excluding albuterol/salbutamol inhalation aerosol provided at Visit 1). 3. Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subject's asthma status or the subject's ability to participate in the study. 4.Asthma exacerbation, defined as any worsening of asthma requiring any treatment other than rescue albuterol/salbutamol or regular inhaled corticosteroid use. This includes requiring the use of systemic corticosteroids and / or emergency room visit or hospitalization or a change in subject's regular inhaled corticosteroid dose. 5.A subject will not be eligible for randomization if he/she has an abnormal visual oropharyngeal exam at the randomization Visit 3 (visual clinical evidence of oral candidiasis). 6.Non-compliance with completion of the Daily Diary, defined as: -Completion of AM and PM symptom scores on less than 4 days out of the last 7 days immediately preceding Visit 3. -Completion of AM and PM rescue use on less than 4 days out of the last 7 days immediately preceding Visit 3. -Completion of AM and PM PEF measurements on less than 4 days out of the last 7 days immediately preceding Visit 3. -Recording run-in asthma medication use on less than 4 days out of the last 7 days immediately preceding Visit 3.
Gender:	Both
Minimum Age:	12 Year
Maximum Age:
Enrollment:	599
Enrollment Type:	Anticipated
Healthy Volunteers?:	none
Central Contact:	US GSK Clinical Trials Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:	EU GSK Clinical Trials Call Center
Backup Central Contact Phone:	+44 (0) 20 8990 4466
Backup Central Contact Email:	GSKClinicalSupportHD@gsk.com
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 Australia (click to view all sites in Australia) GSK Investigational Site Adelaide, South Australia, 5000; Completed; GSK Investigational Site Clayton, Victoria, 3168; Completed; GSK Investigational Site Nedlands, Western Australia, 6009; Completed; Bulgaria (click to view all sites in Bulgaria) GSK Investigational Site Ruse, , 7000; Completed; GSK Investigational Site Sofia, , 1431; Completed; GSK Investigational Site Pleven, , 5800; Completed; Canada (click to view all sites in Canada) GSK Investigational Site Bay Roberts, Newfoundland and Labrador, A0A 1G0; Completed; GSK Investigational Site Brampton, Ontario, L6T 3T1; Completed; GSK Investigational Site Ottawa, Ontario, K1Y 4G2; Completed; GSK Investigational Site Mississauga, Ontario, L5M 2V8; Completed; GSK Investigational Site Toronto, Ontario, M3H 5S4; Completed; GSK Investigational Site Ajax, Ontario, L1S 2J5; Completed; GSK Investigational Site Sherbrooke, Québec, J1H 1Z1; Completed; GSK Investigational Site Sainte-Foy, Québec, G1V 4G5; Completed; GSK Investigational Site Quebec City, Québec, G1V 4M6; Completed; Chile (click to view all sites in Chile) GSK Investigational Site Santiago, , 8380453; Completed; GSK Investigational Site Santiago, Región Metro De Santiago, 7500551; Completed; GSK Investigational Site Puente Alto - Santiago, Región Metro De Santiago, 8207257; Completed; GSK Investigational Site Valparaiso, Valparaíso, 2352499; Completed; Czech Republic (click to view all sites in Czech Republic) GSK Investigational Site Brno, , 639 00; Completed; GSK Investigational Site Tabor, , ; Completed; GSK Investigational Site Beroun, , 266 01; Completed; GSK Investigational Site Kutna Hora, , 284 01; Completed; Estonia (click to view all sites in Estonia) GSK Investigational Site Tartu, , 51014; Completed; GSK Investigational Site Tallinn, , 13619; Completed; France (click to view all sites in France) GSK Investigational Site Grenoble, , 38000; Completed; GSK Investigational Site Montpellier, , 34295; Completed; GSK Investigational Site Marseille, , 13009; Completed; GSK Investigational Site Nantes, , 44093; Completed; Germany (click to view all sites in Germany) GSK Investigational Site Berlin, Berlin, 13597; Completed; GSK Investigational Site Berlin, Berlin, 10367; Completed; GSK Investigational Site Berlin, Berlin, 10717; Completed; GSK Investigational Site Gelnhausen, Hessen, 63571; Completed; GSK Investigational Site Hannover, Niedersachsen, 30167; Completed; Mexico (click to view all sites in Mexico) GSK Investigational Site Mexico, , 04530; Completed; GSK Investigational Site Distrito Federal, , 06760; Completed; GSK Investigational Site Mexico, , 11550; Completed; GSK Investigational Site Guadalajara, Jalisco, 44100; Completed; GSK Investigational Site Zapopan, Jalisco, 45040; Completed; Netherlands (click to view all sites in Netherlands) GSK Investigational Site HENGELO, , 7555 DL; Completed; GSK Investigational Site UTRECHT, , 3584 EA; Completed; GSK Investigational Site AMSTERDAM, , 1034 CS; Completed; GSK Investigational Site EINDHOVEN, , 5623 EJ; Completed; GSK Investigational Site SCHIEDAM, , 3116 BA; Completed; Peru (click to view all sites in Peru) GSK Investigational Site Lima, Lima, Lima 27; Completed; GSK Investigational Site Lima, Lima, Lima 1; Completed; GSK Investigational Site Lima, Lima, Lima 27; Completed; Poland (click to view all sites in Poland) GSK Investigational Site Bialystok, , 15-276; Completed; GSK Investigational Site Warszawa, , 02-097; Completed; GSK Investigational Site Wroclaw, , 50-434; Completed; Russian Federation (click to view all sites in Russian Federation) GSK Investigational Site Tomsk, , 634001; Completed; GSK Investigational Site Moscow, , 115 280; Completed; GSK Investigational Site Kazan, , 420015; Completed; GSK Investigational Site Irkutsk, , 664005; Completed; South Africa (click to view all sites in South Africa) GSK Investigational Site Durban, , 4001; Completed; GSK Investigational Site Mowbray, , 7700; Completed; GSK Investigational Site Amanzimtoti, , 4126; Completed; GSK Investigational Site BELLVILLE, , 7530; Completed; Thailand (click to view all sites in Thailand) GSK Investigational Site Bangkok, , 10400; Completed; GSK Investigational Site Bangkok, , 10330; Completed; United States (click to view all sites in United States) Arizona (click to view) GSK Investigational Site Phoenix, Arizona, 85028; Completed; Arkansas (click to view) GSK Investigational Site Little Rock, Arkansas, 72211-3733; Completed; GSK Investigational Site Fort Smith, Arkansas, 72903; Completed; California (click to view) GSK Investigational Site West Covina, California, 91790; Completed; GSK Investigational Site Riverside, California, 92506; Completed; GSK Investigational Site Roseville, California, 95678; Completed; GSK Investigational Site Long Beach, California, 90808; Completed; GSK Investigational Site Los Angeles, California, 90095-1752; Completed; GSK Investigational Site Walnut Creek, California, 94598; Completed; GSK Investigational Site Long Beach, California, 90806; Completed; GSK Investigational Site Fresno, California, 93720; Completed; GSK Investigational Site Huntington Beach, California, 92647; Completed; GSK Investigational Site San Diego, California, 92120; Completed; GSK Investigational Site Los Angeles, California, 90048; Completed; GSK Investigational Site Palmdale, California, 93551; Completed; GSK Investigational Site Granada Hills, California, 91344; Completed; GSK Investigational Site Torrance, California, 90505; Completed; Colorado (click to view) GSK Investigational Site Colorado Springs, Colorado, 80910; Completed; GSK Investigational Site Wheat Ridge, Colorado, 80033; Completed; Connecticut (click to view) GSK Investigational Site Waterbury, Connecticut, 06708; Completed; GSK Investigational Site Bridgeport, Connecticut, 06606; Completed; Florida (click to view) GSK Investigational Site West Palm Beach, Florida, 33401; Completed; GSK Investigational Site Daytona Beach, Florida, 32114; Completed; GSK Investigational Site Cocoa, Florida, 32927; Completed; GSK Investigational Site Boca Raton, Florida, 33487; Completed; GSK Investigational Site Tampa, Florida, 33613; Completed; GSK Investigational Site Largo, Florida, 33770; Completed; GSK Investigational Site Ocala, Florida, 34471; Completed; GSK Investigational Site Winter Park, Florida, 32789; Completed; GSK Investigational Site Miami, Florida, 33157; Completed; GSK Investigational Site Miami, Florida, 33175; Completed; Georgia (click to view) GSK Investigational Site Gainesville, Georgia, 30501; Completed; Illinois (click to view) GSK Investigational Site Gurnee, Illinois, 60031; Completed; GSK Investigational Site Chicago, Illinois, 60617; Completed; GSK Investigational Site DeKalb, Illinois, 60115; Completed; GSK Investigational Site Bloomingdale/Illinois, Illinois, 60108; Completed; Indiana (click to view) GSK Investigational Site Evansville, Indiana, 47713; Completed; Iowa (click to view) GSK Investigational Site Iowa City, Iowa, 52240; Completed; Kansas (click to view) GSK Investigational Site Lenexa, Kansas, 66215; Completed; Kentucky (click to view) GSK Investigational Site Crescent Springs, Kentucky, 41017; Completed; Louisiana (click to view) GSK Investigational Site Metairie, Louisiana, 70002; Completed; Maine (click to view) GSK Investigational Site Bangor, Maine, 04401; Completed; Massachusetts (click to view) GSK Investigational Site North Dartmouth, Massachusetts, 02747; Completed; GSK Investigational Site North Dartmouth, Massachusetts, 02747; Completed; Michigan (click to view) GSK Investigational Site Detroit, Michigan, 48221; Completed; GSK Investigational Site Ypsilanti, Michigan, 48197; Completed; GSK Investigational Site Taylor, Michigan, 48180; Completed; Minnesota (click to view) GSK Investigational Site Rochester, Minnesota, 55905; Completed; Mississippi (click to view) GSK Investigational Site Jackson, Mississippi, 39202; Completed; Missouri (click to view) GSK Investigational Site St. Louis, Missouri, 63141; Completed; GSK Investigational Site Rolla, Missouri, 65401; Completed; GSK Investigational Site St. Louis, Missouri, 63143; Completed; GSK Investigational Site Warrensburg, Missouri, 64093; Completed; Montana (click to view) GSK Investigational Site Butte, Montana, 59701; Completed; GSK Investigational Site Missoula, Montana, 59808; Completed; GSK Investigational Site Billings, Montana, 59101; Completed; Nevada (click to view) GSK Investigational Site Las Vegas, Nevada, 89107; Completed; New Jersey (click to view) GSK Investigational Site Skillman, New Jersey, 08558; Completed; GSK Investigational Site Clifton/New Jersey, New Jersey, 7011; Completed; GSK Investigational Site Little Silver, New Jersey, 07739; Completed; GSK Investigational Site Hillsborough, New Jersey, 08844; Completed; New York (click to view) GSK Investigational Site Ithaca, New York, 14850; Completed; GSK Investigational Site East Syracuse, New York, 13057; Completed; GSK Investigational Site Rockville Center, New York, 11570; Completed; North Carolina (click to view) GSK Investigational Site Raleigh, North Carolina, 27607; Completed; GSK Investigational Site Greenville, North Carolina, 27834; Completed; GSK Investigational Site Greensboro, North Carolina, 27408; Completed; Ohio (click to view) GSK Investigational Site Cincinnati, Ohio, 45231; Completed; GSK Investigational Site Canton, Ohio, 44718; Completed; GSK Investigational Site Columbus, Ohio, 43235; Completed; GSK Investigational Site Cleveland, Ohio, 44113; Completed; Oklahoma (click to view) GSK Investigational Site Oklahoma City, Oklahoma, 73120; Completed; GSK Investigational Site Oklahoma City, Oklahoma, 73112; Completed; Oregon (click to view) GSK Investigational Site Medford, Oregon, 97504; Completed; GSK Investigational Site Eugene, Oregon, 97401; Completed; Pennsylvania (click to view) GSK Investigational Site Pittsburgh, Pennsylvania, 15243; Completed; South Carolina (click to view) GSK Investigational Site Bluffton, South Carolina, 29910; Completed; GSK Investigational Site Charleston, South Carolina, 29407; Completed; GSK Investigational Site Mt. Pleasant, South Carolina, 29464; Completed; Tennessee (click to view) GSK Investigational Site Knoxville, Tennessee, 37909; Completed; Texas (click to view) GSK Investigational Site Fort Worth, Texas, 76104; Completed; GSK Investigational Site San Antonio, Texas, 78229; Completed; GSK Investigational Site San Antonio, Texas, 78229; Completed; GSK Investigational Site Waco, Texas, 76712; Completed; GSK Investigational Site San Antonio, Texas, 78233; Completed; GSK Investigational Site Plano, Texas, 75093; Completed; GSK Investigational Site Dallas, Texas, 75231; Completed; GSK Investigational Site Boerne, Texas, 78006; Completed; GSK Investigational Site Dickinson, Texas, 77539; Completed; GSK Investigational Site Dallas, Texas, 75246; Completed; GSK Investigational Site San Antonio, Texas, 78205; Completed; Vermont (click to view) GSK Investigational Site South Burlington, Vermont, 05403; Completed; Virginia (click to view) GSK Investigational Site Manassas, Virginia, 20110; Completed; Washington (click to view) GSK Investigational Site Spokane, Washington, 99207; Completed; GSK Investigational Site Bellingham, Washington, 98225; Completed;

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Protocol Summary for FFA109684