SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.

Asthma Clinical Trial

— AUSTRI  

Official title:

SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475721
• Other study ID #: 115359
• Status: Completed
• Phase: Phase 4
• Start date: November 18, 2011
• Est. completion date: June 23, 2015

Study information

• Verified date: August 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.

Description:

Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in January of 2016. This is the final update, as this study is complete.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11751
• Est. completion date: June 23, 2015
• Est. primary completion date: June 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Provided consent to participate in the study

• Male or female, 12 years of age and older

• Clinical diagnosis of asthma for at least 1 year prior to the randomization

• Clinic PEF of greater than or equal to 50% of predicted normal value

• Subject must be appropriately using one of the treatments for asthma listed in the protocol

• Subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a DISKUS inhaler

• Subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization:

• requiring treatment with systemic corticosteroids

• an asthma-related hospitalization

Exclusion Criteria:

• History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support

• Concurrent respiratory disease other than asthma

• Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.

• Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine

• Presence of a bacterial or viral respiratory infection that is not resolved at randomization

• An asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization

• More than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization

• Subject must not meet unstable asthma severity criteria as listed in the protocol

• Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)

• Pregnancy, breast-feeding or planned pregnancy during the study

• A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ADVAIR 100/50mcg
fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
• ADVAIR 250/50mcg
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
• ADVAIR 500/50mcg
fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months
• FLOVENT 100mcg
fluticasone propionate (100) twice daily (AM and PM) for 6 months
• FLOVENT 250mcg
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
• FLOVENT 500mcg
fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Concepcion del Uruguay	Entre Ríos
Argentina	GSK Investigational Site	Derqui, Pilar	Buenos Aires
Argentina	GSK Investigational Site	La Plata
Argentina	GSK Investigational Site	Lanús
Argentina	GSK Investigational Site	Mendoza
Argentina	GSK Investigational Site	Nueve de Julio	Buenos Aires
Argentina	GSK Investigational Site	Parana	Entre Ríos
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Rosario
Argentina	GSK Investigational Site	San Martin	Buenos Aires
Argentina	GSK Investigational Site	San Miguel de Tucuman	Tucumán
Australia	GSK Investigational Site	Auchenflower	Queensland
Australia	GSK Investigational Site	Bedford Park	South Australia
Australia	GSK Investigational Site	Broadmeadow	New South Wales
Australia	GSK Investigational Site	Clayton	Victoria
Australia	GSK Investigational Site	Parkville
Australia	GSK Investigational Site	Randwick	New South Wales
Australia	GSK Investigational Site	Redcliffe	Queensland
Australia	GSK Investigational Site	Subiaco	Western Australia
Australia	GSK Investigational Site	Westmead	New South Wales
Australia	GSK Investigational Site	Woolloongabba	Queensland
Austria	GSK Investigational Site	Feldkirch
Austria	GSK Investigational Site	Salzburg
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Wels
Austria	GSK Investigational Site	Wien
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Hamois (Natoye)
Belgium	GSK Investigational Site	Jambes
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Montigny-Le-Tilleul
Bulgaria	GSK Investigational Site	Blagoevgrad
Bulgaria	GSK Investigational Site	Pazardjik
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Sliven
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Troyan
Bulgaria	GSK Investigational Site	Varna
Bulgaria	GSK Investigational Site	Veliko Tarnovo
Bulgaria	GSK Investigational Site	Vidin
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Fort Erie	Ontario
Canada	GSK Investigational Site	Grimsby	Ontario
Canada	GSK Investigational Site	Kingston	Ontario
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Newmarket	Ontario
Canada	GSK Investigational Site	Oshawa	Ontario
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Victoria	British Columbia
Canada	GSK Investigational Site	Windsor	Ontario
Chile	GSK Investigational Site	Santiago
Chile	GSK Investigational Site	Temuco	Región De La Araucania
Chile	GSK Investigational Site	Valdivia
Chile	GSK Investigational Site	Valparaiso	Valparaíso
Chile	GSK Investigational Site	Viña del Mar
Chile	GSK Investigational Site	Viña del Mar
Colombia	GSK Investigational Site	Bogota
Colombia	GSK Investigational Site	Bucaramanga
Croatia	GSK Investigational Site	Cakovec
Croatia	GSK Investigational Site	Senj
Croatia	GSK Investigational Site	Zadar
Croatia	GSK Investigational Site	Zagreb
Czechia	GSK Investigational Site	Havlickuv brod
Czechia	GSK Investigational Site	Hlucin
Czechia	GSK Investigational Site	Jaromer
Czechia	GSK Investigational Site	Kyjov
Czechia	GSK Investigational Site	Plzen
Czechia	GSK Investigational Site	Plzen
Czechia	GSK Investigational Site	Praha 1
Czechia	GSK Investigational Site	Praha 13
Czechia	GSK Investigational Site	Praha 4
Czechia	GSK Investigational Site	Praha 6
Czechia	GSK Investigational Site	Praha 6
Czechia	GSK Investigational Site	Svitavy
Czechia	GSK Investigational Site	Tremosna
Denmark	GSK Investigational Site	Copenhagen
Denmark	GSK Investigational Site	Rosklide
Germany	GSK Investigational Site	Aschaffenburg	Bayern
Germany	GSK Investigational Site	Auerbach	Sachsen
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Bad Arolsen	Hessen
Germany	GSK Investigational Site	Bad Lippspringe	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bad Pyrmont	Niedersachsen
Germany	GSK Investigational Site	Bad Woerrishofen	Bayern
Germany	GSK Investigational Site	Beckum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bensheim	Hessen
Germany	GSK Investigational Site	Bergisch Gladbach	Nordrhein-Westfalen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Boehlen	Sachsen
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bruchsal	Baden-Wuerttemberg
Germany	GSK Investigational Site	Deggingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Delitzsch	Sachsen
Germany	GSK Investigational Site	Detmold	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dillingen	Saarland
Germany	GSK Investigational Site	Engelskirchen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Feldkirchen	Bayern
Germany	GSK Investigational Site	Frankenberg	Hessen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt/Main	Hessen
Germany	GSK Investigational Site	Fuerth	Bayern
Germany	GSK Investigational Site	Gars Am Inn	Bayern
Germany	GSK Investigational Site	Georgensgmuend	Bayern
Germany	GSK Investigational Site	Goettingen	Niedersachsen
Germany	GSK Investigational Site	Grossheirath	Bayern
Germany	GSK Investigational Site	Hagen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Herne	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hoechstadt	Bayern
Germany	GSK Investigational Site	Klappholz	Schleswig-Holstein
Germany	GSK Investigational Site	Kleve-Materborn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koblenz	Rheinland-Pfalz
Germany	GSK Investigational Site	Krefeld	Nordrhein-Westfalen
Germany	GSK Investigational Site	Lahnau	Hessen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Meissen	Sachsen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Neuoetting	Bayern
Germany	GSK Investigational Site	Neuss	Nordrhein-Westfalen
Germany	GSK Investigational Site	Offenbach	Hessen
Germany	GSK Investigational Site	Potsdam	Brandenburg
Germany	GSK Investigational Site	Potsdam	Brandenburg
Germany	GSK Investigational Site	Rathenow	Brandenburg
Germany	GSK Investigational Site	Ratingen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Raubach	Rheinland-Pfalz
Germany	GSK Investigational Site	Reinfeld	Schleswig-Holstein
Germany	GSK Investigational Site	Rhaunen	Rheinland-Pfalz
Germany	GSK Investigational Site	Rodgau	Hessen
Germany	GSK Investigational Site	Ruesselsheim	Hessen
Germany	GSK Investigational Site	Saarbruecken	Saarland
Germany	GSK Investigational Site	Schwalmstadt	Hessen
Germany	GSK Investigational Site	Solingen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Telgte	Nordrhein-Westfalen
Germany	GSK Investigational Site	Teuchern	Sachsen-Anhalt
Germany	GSK Investigational Site	Vilshofen	Bayern
Germany	GSK Investigational Site	Weissenhorn	Bayern
Germany	GSK Investigational Site	Witten	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wolfsburg	Niedersachsen
Germany	GSK Investigational Site	Wuppertal	Nordrhein-Westfalen
Germany	GSK Investigational Site	Zerbst	Sachsen-Anhalt
Hungary	GSK Investigational Site	Baja
Hungary	GSK Investigational Site	Balassagyarmat
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Debrecen
Hungary	GSK Investigational Site	Kaposvár
Hungary	GSK Investigational Site	Komló
Hungary	GSK Investigational Site	Mosonmagyaróvár
Hungary	GSK Investigational Site	Nagykanizsa
Hungary	GSK Investigational Site	Rackeve
Hungary	GSK Investigational Site	Siófok
Hungary	GSK Investigational Site	Szolnok
Indonesia	GSK Investigational Site	Denpasar
Indonesia	GSK Investigational Site	Depok Timur
Indonesia	GSK Investigational Site	Jakarta
Indonesia	GSK Investigational Site	Jakarta
Indonesia	GSK Investigational Site	Jakarta
Indonesia	GSK Investigational Site	Jakarta
Indonesia	GSK Investigational Site	Malang
Indonesia	GSK Investigational Site	Medan
Indonesia	GSK Investigational Site	Palembang
Indonesia	GSK Investigational Site	Semarang
Indonesia	GSK Investigational Site	Surakarta
Italy	GSK Investigational Site	Arenzano	Liguria
Italy	GSK Investigational Site	Bergamo	Lombardia
Italy	GSK Investigational Site	Brescia
Italy	GSK Investigational Site	Catania	Sicilia
Italy	GSK Investigational Site	Firenze	Toscana
Italy	GSK Investigational Site	Messina
Italy	GSK Investigational Site	Milano
Italy	GSK Investigational Site	Milano
Italy	GSK Investigational Site	Milano
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Monza
Italy	GSK Investigational Site	Palermo	Sicilia
Italy	GSK Investigational Site	Parma	Emilia-Romagna
Italy	GSK Investigational Site	Pavia	Lombardia
Italy	GSK Investigational Site	Roma
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Sesto San Giovanni
Korea, Republic of	GSK Investigational Site	Bucheon
Korea, Republic of	GSK Investigational Site	Bucheon-si,
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Chuncheon
Korea, Republic of	GSK Investigational Site	Gwangju
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Latvia	GSK Investigational Site	Kuldiga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Tukums
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Klaipeda
Lithuania	GSK Investigational Site	Siauliai
Lithuania	GSK Investigational Site	Utena
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Malaysia	GSK Investigational Site	Alor Setar
Malaysia	GSK Investigational Site	Kota Bharu
Malaysia	GSK Investigational Site	Kuala Pilah
Malaysia	GSK Investigational Site	Selangor
Malaysia	GSK Investigational Site	Sungai Buloh
Mexico	GSK Investigational Site	Aguascalientes, Ags	Aguascalientes
Mexico	GSK Investigational Site	Chihuahua
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Huixquilucan
Mexico	GSK Investigational Site	Monterrey
Mexico	GSK Investigational Site	Monterrey
Mexico	GSK Investigational Site	Zapopan
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	San Borja, Lima
Philippines	GSK Investigational Site	Dasmariñas, Cavite
Philippines	GSK Investigational Site	Davao
Philippines	GSK Investigational Site	Las Pinas
Philippines	GSK Investigational Site	Los Banos
Philippines	GSK Investigational Site	Pulilan
Philippines	GSK Investigational Site	Quezon City
Poland	GSK Investigational Site	Bielsko-Biala
Poland	GSK Investigational Site	Brzesko
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Bystra
Poland	GSK Investigational Site	Cieszyn
Poland	GSK Investigational Site	Debica
Poland	GSK Investigational Site	Elblag
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Gdanska
Poland	GSK Investigational Site	Glucholazy
Poland	GSK Investigational Site	Jelenia Gora
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Libiaz
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lubin
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Radomsko
Poland	GSK Investigational Site	Ruda Slaska
Poland	GSK Investigational Site	Rudka
Poland	GSK Investigational Site	Rzeszow
Poland	GSK Investigational Site	Sandomierz
Poland	GSK Investigational Site	Sopot
Poland	GSK Investigational Site	Szczecin
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wodzislaw Slaski
Poland	GSK Investigational Site	Wolomin
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Zabrze
Poland	GSK Investigational Site	Zabrze
Poland	GSK Investigational Site	Zgierz
Romania	GSK Investigational Site	Brasov
Romania	GSK Investigational Site	Cluj-Napoca
Romania	GSK Investigational Site	Sibiu
Russian Federation	GSK Investigational Site	Chelyabinsk
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Kirov
Russian Federation	GSK Investigational Site	Krasnodar
Russian Federation	GSK Investigational Site	Krasnoyarsk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Novgorod
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Orenburg
Russian Federation	GSK Investigational Site	Pyatigorsk
Russian Federation	GSK Investigational Site	Rostov-on-Don
Russian Federation	GSK Investigational Site	Ryazan
Russian Federation	GSK Investigational Site	Saint Petersburg
Russian Federation	GSK Investigational Site	Saint Petersburg
Russian Federation	GSK Investigational Site	Saint Petersburg
Russian Federation	GSK Investigational Site	Saint Petersburg
Russian Federation	GSK Investigational Site	Saint-Petersburg
Russian Federation	GSK Investigational Site	Saint-Petersburg
Russian Federation	GSK Investigational Site	Saratov
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Voronezh
Russian Federation	GSK Investigational Site	Yaroslavl
Serbia	GSK Investigational Site	Belgrade
Serbia	GSK Investigational Site	Belgrade
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Kralovsky Chlmec
Slovakia	GSK Investigational Site	Levice
Slovakia	GSK Investigational Site	Martin
Slovakia	GSK Investigational Site	Sturovo
Slovakia	GSK Investigational Site	Trnava
South Africa	GSK Investigational Site	Bellville
South Africa	GSK Investigational Site	Benoni
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Cape Town	Gauteng
South Africa	GSK Investigational Site	Claremont
South Africa	GSK Investigational Site	Die Wilgers
South Africa	GSK Investigational Site	Durban
South Africa	GSK Investigational Site	Durban
South Africa	GSK Investigational Site	Eloffsdal	Gauteng
South Africa	GSK Investigational Site	Gatesville
South Africa	GSK Investigational Site	Krugersdorp	Gauteng
South Africa	GSK Investigational Site	Middelburg
South Africa	GSK Investigational Site	Port Elizabeth	Eastern Cape
South Africa	GSK Investigational Site	Pretoria
South Africa	GSK Investigational Site	Pretoria
South Africa	GSK Investigational Site	Pretoria	Gauteng
South Africa	GSK Investigational Site	Somerset West
South Africa	GSK Investigational Site	Soweto
South Africa	GSK Investigational Site	Thabazimbi
South Africa	GSK Investigational Site	Welkom
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Basurto/Bilbao
Spain	GSK Investigational Site	Burgos
Spain	GSK Investigational Site	Cádiz
Spain	GSK Investigational Site	Canet De Mar - Barcelona
Spain	GSK Investigational Site	Elche
Spain	GSK Investigational Site	Illescas-Toledo
Spain	GSK Investigational Site	La Coruña
Spain	GSK Investigational Site	Lleida
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Majadahonda (Madrid)
Spain	GSK Investigational Site	Mataro
Spain	GSK Investigational Site	Pozuelo De Alarcón/Madrid
Spain	GSK Investigational Site	Sabadell (Barcelona)
Spain	GSK Investigational Site	Sagunto/Valencia
Spain	GSK Investigational Site	Sant Boi de Llobregat
Spain	GSK Investigational Site	Santiago de Compostela
Spain	GSK Investigational Site	Tarrasa, Barcelona
Spain	GSK Investigational Site	Torrelavega
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valladolid
Spain	GSK Investigational Site	Vic (Barcelona)
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Keelung
Taiwan	GSK Investigational Site	Koahsiung
Taiwan	GSK Investigational Site	Putzu
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Ukraine	GSK Investigational Site	Cherkassy
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Ivano-Frankivsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kiev
Ukraine	GSK Investigational Site	Kryvyi Rih
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Lviv
Ukraine	GSK Investigational Site	Odesa
Ukraine	GSK Investigational Site	Odesa
Ukraine	GSK Investigational Site	Odesa
Ukraine	GSK Investigational Site	Poltava
Ukraine	GSK Investigational Site	Simferopol
Ukraine	GSK Investigational Site	Sumy
Ukraine	GSK Investigational Site	Sumy
Ukraine	GSK Investigational Site	Sumy
Ukraine	GSK Investigational Site	Ternopil
Ukraine	GSK Investigational Site	Vinnytsia
Ukraine	GSK Investigational Site	Zaporizhzhia
Ukraine	GSK Investigational Site	Zaporizhzhya
Ukraine	GSK Investigational Site	Zhytomyr
United Kingdom	GSK Investigational Site	Barry
United Kingdom	GSK Investigational Site	Bath	Somerset
United Kingdom	GSK Investigational Site	Bedford	Bedfordshire
United Kingdom	GSK Investigational Site	Bexhill-on-Sea
United Kingdom	GSK Investigational Site	Brighton	Sussex East
United Kingdom	GSK Investigational Site	Cardiff	Glamorgan
United Kingdom	GSK Investigational Site	Chertsey, Surrey
United Kingdom	GSK Investigational Site	Glasgow
United Kingdom	GSK Investigational Site	Kent
United Kingdom	GSK Investigational Site	Leicester
United Kingdom	GSK Investigational Site	Liverpool	Merseyside
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester	Greater Manchester
United Kingdom	GSK Investigational Site	Merseyside
United Kingdom	GSK Investigational Site	Penzance
United Kingdom	GSK Investigational Site	Stoke on Trent
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Alexandria	Louisiana
United States	GSK Investigational Site	Alexandria	Virginia
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Annapolis	Maryland
United States	GSK Investigational Site	Arlington	Texas
United States	GSK Investigational Site	Asheboro	North Carolina
United States	GSK Investigational Site	Asheville	North Carolina
United States	GSK Investigational Site	Atco	New Jersey
United States	GSK Investigational Site	Athens	Alabama
United States	GSK Investigational Site	Austell	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Avon	Indiana
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bangor	Maine
United States	GSK Investigational Site	Belle Vernon	Pennsylvania
United States	GSK Investigational Site	Belle Vernon	Pennsylvania
United States	GSK Investigational Site	Bellevue	Nebraska
United States	GSK Investigational Site	Bellingham	Washington
United States	GSK Investigational Site	Bensalem	Pennsylvania
United States	GSK Investigational Site	Billings	Montana
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Bountiful	Utah
United States	GSK Investigational Site	Boynton Beach	Florida
United States	GSK Investigational Site	Brandon	Florida
United States	GSK Investigational Site	Brick	New Jersey
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Brooklyn	New York
United States	GSK Investigational Site	Brownsburg	Indiana
United States	GSK Investigational Site	Buckley	Michigan
United States	GSK Investigational Site	Calabash	North Carolina
United States	GSK Investigational Site	Carnegie	Pennsylvania
United States	GSK Investigational Site	Cary	North Carolina
United States	GSK Investigational Site	Centerville	Ohio
United States	GSK Investigational Site	Champaign	Illinois
United States	GSK Investigational Site	Chandler	Arizona
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Chaska	Minnesota
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Chelsea	Michigan
United States	GSK Investigational Site	Chesterfield	Michigan
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Clinton	Utah
United States	GSK Investigational Site	Clyde	North Carolina
United States	GSK Investigational Site	Cocoa	Florida
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Columbia	Maryland
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Columbus	Georgia
United States	GSK Investigational Site	Coral Gables	Florida
United States	GSK Investigational Site	Corning	New York
United States	GSK Investigational Site	Corsicana	Texas
United States	GSK Investigational Site	Council Bluffs	Iowa
United States	GSK Investigational Site	Covington	Louisiana
United States	GSK Investigational Site	Crown Point	Indiana
United States	GSK Investigational Site	Dakota Dunes	South Dakota
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Danbury	Connecticut
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Destin	Florida
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Dinuba	California
United States	GSK Investigational Site	Doral	Florida
United States	GSK Investigational Site	Doral	Florida
United States	GSK Investigational Site	Downingtown	Pennsylvania
United States	GSK Investigational Site	Duncanville	Texas
United States	GSK Investigational Site	East Greenwich	Rhode Island
United States	GSK Investigational Site	Edison	New Jersey
United States	GSK Investigational Site	Edison	New Jersey
United States	GSK Investigational Site	Elizabeth	New Jersey
United States	GSK Investigational Site	Elizabeth	New Jersey
United States	GSK Investigational Site	Endwell	New York
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Evergreen Park	Illinois
United States	GSK Investigational Site	Fall River	Massachusetts
United States	GSK Investigational Site	Falls Church	Vermont
United States	GSK Investigational Site	Fargo	North Dakota
United States	GSK Investigational Site	Fargo	North Dakota
United States	GSK Investigational Site	Fenton	Michigan
United States	GSK Investigational Site	Flagstaff	Arizona
United States	GSK Investigational Site	Florence	Alabama
United States	GSK Investigational Site	Florence	South Carolina
United States	GSK Investigational Site	Fort Collins	Colorado
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Franklin	Indiana
United States	GSK Investigational Site	Freehold	New Jersey
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Gainesville	Georgia
United States	GSK Investigational Site	Germantown	Tennessee
United States	GSK Investigational Site	Glen Ellyn	Illinois
United States	GSK Investigational Site	Glenview	Illinois
United States	GSK Investigational Site	Golden	Colorado
United States	GSK Investigational Site	Goodyear	Arizona
United States	GSK Investigational Site	Granada Hills	California
United States	GSK Investigational Site	Great Falls	Montana
United States	GSK Investigational Site	Green Valley	Arizona
United States	GSK Investigational Site	Greenfield	Indiana
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Greenwood	South Carolina
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Groveport	Ohio
United States	GSK Investigational Site	Gun Barrel City	Texas
United States	GSK Investigational Site	Hampton	Virginia
United States	GSK Investigational Site	Harbor City	California
United States	GSK Investigational Site	Hazard	Kentucky
United States	GSK Investigational Site	Henderson	Nevada
United States	GSK Investigational Site	Hialeah	Florida
United States	GSK Investigational Site	Holland	Pennsylvania
United States	GSK Investigational Site	Hollywood	Maryland
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntingdon Valley	Pennsylvania
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Huntington Park	California
United States	GSK Investigational Site	Hutchinson	Kansas
United States	GSK Investigational Site	Hyannis	Massachusetts
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Interlochen	Michigan
United States	GSK Investigational Site	Iowa City	Iowa
United States	GSK Investigational Site	Irving	Texas
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jenkintown	Pennsylvania
United States	GSK Investigational Site	Johnston	Rhode Island
United States	GSK Investigational Site	Jupiter	Florida
United States	GSK Investigational Site	Kalamazoo	Michigan
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Katy	Texas
United States	GSK Investigational Site	Kerrville	Texas
United States	GSK Investigational Site	Killeen	Texas
United States	GSK Investigational Site	Kingwood	Texas
United States	GSK Investigational Site	Lake Oswego	Oregon
United States	GSK Investigational Site	Lansdale	Pennsylvania
United States	GSK Investigational Site	Largo	Maryland
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Latrobe	Pennsylvania
United States	GSK Investigational Site	Lawrenceville	Georgia
United States	GSK Investigational Site	Layton	Utah
United States	GSK Investigational Site	Lewisville	Texas
United States	GSK Investigational Site	Lexington	North Carolina
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Lilburn	Georgia
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Lomita	California
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Lufkin	Texas
United States	GSK Investigational Site	Lumberton	New Jersey
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Maitland	Florida
United States	GSK Investigational Site	Marion	Ohio
United States	GSK Investigational Site	Marlton	New Jersey
United States	GSK Investigational Site	McKenzie	Tennessee
United States	GSK Investigational Site	McKinney	Texas
United States	GSK Investigational Site	Melbourne	Florida
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Middleburg Heights	Ohio
United States	GSK Investigational Site	Midlothian	Virginia
United States	GSK Investigational Site	Midlothian	Virginia
United States	GSK Investigational Site	Midvale	Utah
United States	GSK Investigational Site	Milford	Connecticut
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Montgomery	Alabama
United States	GSK Investigational Site	Morganton	North Carolina
United States	GSK Investigational Site	Morgantown	West Virginia
United States	GSK Investigational Site	Muncie	Indiana
United States	GSK Investigational Site	Murray	Utah
United States	GSK Investigational Site	Napa	California
United States	GSK Investigational Site	New Port Richey	Florida
United States	GSK Investigational Site	New Windsor	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newburgh	New York
United States	GSK Investigational Site	Newport Beach	California
United States	GSK Investigational Site	Niles	Michigan
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Normal	Illinois
United States	GSK Investigational Site	Novi	Michigan
United States	GSK Investigational Site	Oak Lawn	Illinois
United States	GSK Investigational Site	Oak Park	Illinois
United States	GSK Investigational Site	Ocean City	New Jersey
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Overland Park	Kansas
United States	GSK Investigational Site	Overland Park	Kansas
United States	GSK Investigational Site	Oxnard	California
United States	GSK Investigational Site	Paramount	California
United States	GSK Investigational Site	Pell City	Alabama
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Peoria	Arizona
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pinellas Park	Florida
United States	GSK Investigational Site	Pismo Beach	California
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Pomona	California
United States	GSK Investigational Site	Port Gibson	Mississippi
United States	GSK Investigational Site	Port Orchard	Washington
United States	GSK Investigational Site	Portland	Maine
United States	GSK Investigational Site	Puyallup	Washington
United States	GSK Investigational Site	Rapid City	South Dakota
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Ridgewood	New Jersey
United States	GSK Investigational Site	Rincon	Georgia
United States	GSK Investigational Site	Rolling Hills Estates	California
United States	GSK Investigational Site	Roseville	California
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Saint Cloud	Florida
United States	GSK Investigational Site	Saint Petersburg	Florida
United States	GSK Investigational Site	Saint Petersburg	Florida
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Gabriel	California
United States	GSK Investigational Site	San Jose	California
United States	GSK Investigational Site	San Marcos	California
United States	GSK Investigational Site	San Marino	California
United States	GSK Investigational Site	San Ramon	California
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Scottdale	Pennsylvania
United States	GSK Investigational Site	Scottsboro	Alabama
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Shaker Heights	Ohio
United States	GSK Investigational Site	Shelby	North Carolina
United States	GSK Investigational Site	Shelbyville	Tennessee
United States	GSK Investigational Site	Shiloh	Illinois
United States	GSK Investigational Site	Shippensburg	Pennsylvania
United States	GSK Investigational Site	Sierra Vista	Arizona
United States	GSK Investigational Site	Silver Spring	Maryland
United States	GSK Investigational Site	Sioux Falls	South Dakota
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Ohio
United States	GSK Investigational Site	Stevensville	Michigan
United States	GSK Investigational Site	Stockbridge	Georgia
United States	GSK Investigational Site	Suffolk	Virginia
United States	GSK Investigational Site	Sugar Land	Texas
United States	GSK Investigational Site	Tabor City	North Carolina
United States	GSK Investigational Site	Tallahassee	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Thornton	Colorado
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Tomball	Texas
United States	GSK Investigational Site	Toney	Alabama
United States	GSK Investigational Site	Towson	Maryland
United States	GSK Investigational Site	Trenton	New Jersey
United States	GSK Investigational Site	Trinity	Florida
United States	GSK Investigational Site	Tucker	Georgia
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tuscaloosa	Alabama
United States	GSK Investigational Site	Tyler	Texas
United States	GSK Investigational Site	Union	South Carolina
United States	GSK Investigational Site	Uniontown	Pennsylvania
United States	GSK Investigational Site	Utica	New York
United States	GSK Investigational Site	Ventura	California
United States	GSK Investigational Site	Vero Beach	Florida
United States	GSK Investigational Site	Virginia Beach	Virginia
United States	GSK Investigational Site	Vista	California
United States	GSK Investigational Site	Waco	Texas
United States	GSK Investigational Site	Waco	Texas
United States	GSK Investigational Site	Warwick	Rhode Island
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Waterbury	Connecticut
United States	GSK Investigational Site	Wellington	Florida
United States	GSK Investigational Site	West Covina	California
United States	GSK Investigational Site	West Des Moines	Iowa
United States	GSK Investigational Site	West Jordan	Utah
United States	GSK Investigational Site	West Sacramento	California
United States	GSK Investigational Site	Westfield	New York
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Wheaton	Maryland
United States	GSK Investigational Site	Wheeling	Ohio
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Youngstown	Ohio
United States	GSK Investigational Site	Zanesville	Ohio
United States	GSK Investigational Site	Zephyrhills	Florida

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Parexel

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czechia,  Denmark,  Germany,  Hungary,  Indonesia,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)	Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a =24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.	From Day 1 up to 26 weeks
Primary	Number of Participants Experiencing at Least One Asthma Exacerbation	An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.	From Day 1 up to 26 weeks
Secondary	Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death	Hospitalization was defined as an inpatient stay or a =24-hour stay in an observation area in an emergency department or other equivalent facility.	From Day 1 up to 26 weeks
Secondary	Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation	An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.	From Day 1 up to 26 weeks
Secondary	Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours	Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months.	From Day 1 up to 26 weeks

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.