6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old

Asthma Clinical Trial

— VESTRI  

Official title:

A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462344
• Other study ID #: 115358
• Status: Completed
• Phase: Phase 4
• Start date: November 17, 2011
• Est. completion date: November 3, 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 children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6250
• Est. completion date: November 3, 2015
• Est. primary completion date: November 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

Inclusion Criteria:

1. Consent to participate in the study

2. Age 4-11 years old

3. Male or eligible female - Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation

4. Asthma diagnosis for at least 6 months

5. Ability to answer questions regarding asthma control and use a metered dose inhaler and DISKUS

6. A history of clinical varicella infection or recipient of a varicella vaccine in countries where the product label includes a warning regarding more serious chickenpox infections in patients using corticosteroids.

7. History of at least once occurrence of asthma exacerbation within the prior 12 months

8. Currently being treated for asthma and no change in asthma therapy for the last 4 weeks (Eligible subjects include: subjects with use of short-acting beta-agonist, leukotriene receptor antagonist, theophylline, or cromolyn whose asthma is not well-controlled; subjects on low-dose ICS monotherapy whose asthma is not well-controlled; subjects on low-dose ICS and one or more adjunctive therapy whose asthma is either controlled or not well-controlled asthma; subjects on medium-dose ICS monotherapy whose asthma is either controlled or not well-controlled; and subjects on medium-dose ICS and one or more adjunctive therapy whose asthma is well-controlled)

Exclusion Criteria:

1. History of life-threatening asthma

2. Unstable asthma

3. Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms

4. Concurrent respiratory disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma.

5. Respiratory infection

6. Subjects with only exercise-induced asthma

7. An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months

8. Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the last 12 months

9. Other current evidence of clinically significant uncontrolled disease/conditions of any body or organ system

10. Neurological or psychiatric disease or history of drug or alcohol abuse of a subject or his/her guardian which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements

11. Participation in an interventional study or used any investigational drug for any disease state within the last 30 days

12. Any adverse reaction including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy, or vehicle contained within these medication

13. Severe hypersensitivity to cow's milk proteins

14. Administration of prescription or over the counter medications that would significantly affect the course of asthma, or interact with sympathomimetic amines such as: anti-IgE (omalizumab), anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants, beta-adrenergic blockers; phenothiazines, monoamine oxidase inhibitors, or diuretics

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

16. Affiliation with investigator's site, including a immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.

17. 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
• 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

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	Capital Federal
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Concepcion del Uruguay	Entre Ríos
Argentina	GSK Investigational Site	Lanús
Argentina	GSK Investigational Site	Mar del Plata	Buenos Aires
Argentina	GSK Investigational Site	Nueve de Julio	Buenos Aires
Argentina	GSK Investigational Site	Parana	Entre Ríos
Argentina	GSK Investigational Site	San Miguel de Tucuman
Australia	GSK Investigational Site	Auchenflower	Queensland
Australia	GSK Investigational Site	Parkville
Australia	GSK Investigational Site	Randwick
Australia	GSK Investigational Site	Subiaco	Western Australia
Australia	GSK Investigational Site	Westmead	New South Wales
Austria	GSK Investigational Site	Bregenz
Austria	GSK Investigational Site	Feldkirch
Austria	GSK Investigational Site	Wien
Belgium	GSK Investigational Site	Antwerpen
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Gembloux
Belgium	GSK Investigational Site	Hamois (Natoye)
Belgium	GSK Investigational Site	Leuven
Bulgaria	GSK Investigational Site	Blagoevgrad
Bulgaria	GSK Investigational Site	Pleven
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Ruse
Bulgaria	GSK Investigational Site	Ruse
Bulgaria	GSK Investigational Site	Sevlievo
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Stara Zagora
Bulgaria	GSK Investigational Site	Varna
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	Burlington	Ontario
Canada	GSK Investigational Site	Oshawa	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Windsor	Ontario
Chile	GSK Investigational Site	Santiago
Chile	GSK Investigational Site	Valdivia
Chile	GSK Investigational Site	Viña del Mar
Colombia	GSK Investigational Site	Medellin
Croatia	GSK Investigational Site	Cakovec
Croatia	GSK Investigational Site	Dubrovnik
Croatia	GSK Investigational Site	Jastrebarsko
Croatia	GSK Investigational Site	Rijeka
Croatia	GSK Investigational Site	Split
Croatia	GSK Investigational Site	Zagreb
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Ceska Lipa
Czechia	GSK Investigational Site	Olomouc
Czechia	GSK Investigational Site	Praha 4
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Bad Lippspringe	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bad Pyrmont	Niedersachsen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bruchsal	Baden-Wuerttemberg
Germany	GSK Investigational Site	Detmold	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Fuerth	Bayern
Germany	GSK Investigational Site	Geesthacht	Schleswig-Holstein
Germany	GSK Investigational Site	Hagen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hoechstadt	Bayern
Germany	GSK Investigational Site	Kleve-Materborn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Neuss	Nordrhein-Westfalen
Germany	GSK Investigational Site	Reinfeld	Schleswig-Holstein
Germany	GSK Investigational Site	Telgte	Nordrhein-Westfalen
Germany	GSK Investigational Site	Teuchern	Sachsen-Anhalt
Germany	GSK Investigational Site	Weissenhorn	Bayern
Hungary	GSK Investigational Site	Baja
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Miskolc
Hungary	GSK Investigational Site	Nagykanizsa
Hungary	GSK Investigational Site	Rackeve
Hungary	GSK Investigational Site	Szekszárd
Hungary	GSK Investigational Site	Törökbálint
Italy	GSK Investigational Site	Brescia
Italy	GSK Investigational Site	Messina
Italy	GSK Investigational Site	Milano
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Palermo
Italy	GSK Investigational Site	Roma
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Sesto San Giovanni
Korea, Republic of	GSK Investigational Site	Cheongju-si
Korea, Republic of	GSK Investigational Site	Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Pusan
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
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	Riga
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	Utena
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Malaysia	GSK Investigational Site	Ipoh
Malaysia	GSK Investigational Site	Kuala Lumpur
Malaysia	GSK Investigational Site	Kuching
Malaysia	GSK Investigational Site	Seremban, Negeri Sembilan
Malaysia	GSK Investigational Site	Sibu
Malaysia	GSK Investigational Site	Sungai Buloh
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	Nuevo León
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Miraflores	Lima
Peru	GSK Investigational Site	San Borja
Peru	GSK Investigational Site	San Martin de Porres	Lima
Peru	GSK Investigational Site	Santiago de Surco	Lima
Philippines	GSK Investigational Site	Dasmariñas, Cavite
Philippines	GSK Investigational Site	Davao
Philippines	GSK Investigational Site	Pulilan
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Quezon City
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Cieszyn
Poland	GSK Investigational Site	Debica
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Gdanska
Poland	GSK Investigational Site	Jelenia Gora
Poland	GSK Investigational Site	Karpacz
Poland	GSK Investigational Site	Koszalin
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lubin
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Rzeszow
Poland	GSK Investigational Site	Sandomierz
Poland	GSK Investigational Site	Skarzysko-Kamienna
Poland	GSK Investigational Site	Skierniewice
Poland	GSK Investigational Site	Szczecin
Poland	GSK Investigational Site	Szczecin
Poland	GSK Investigational Site	Tarnow
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Zabrze
Poland	GSK Investigational Site	Zabrze
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Sibiu
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Nizhniy Novgorod
Russian Federation	GSK Investigational Site	Novosibirsk
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	St. Petersburg
Russian Federation	GSK Investigational Site	St.Petersburg
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	Cacak
Serbia	GSK Investigational Site	Nis
Serbia	GSK Investigational Site	Novi Sad
Serbia	GSK Investigational Site	Uzice
Slovakia	GSK Investigational Site	Martin
Slovakia	GSK Investigational Site	Nitra
Slovakia	GSK Investigational Site	Trnava
South Africa	GSK Investigational Site	Benoni	Gauteng
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	Claremont
South Africa	GSK Investigational Site	Durban
South Africa	GSK Investigational Site	Krugersdorp	Gauteng
South Africa	GSK Investigational Site	Middelburg
South Africa	GSK Investigational Site	Paarl
South Africa	GSK Investigational Site	Pretoria
South Africa	GSK Investigational Site	Pretoria
South Africa	GSK Investigational Site	Pretoria	Gauteng
South Africa	GSK Investigational Site	Thabazimbi
South Africa	GSK Investigational Site	Welkom	Free State
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Burgos
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Pozuelo De Alarcón/Madrid
Spain	GSK Investigational Site	Sabadell (Barcelona)
Spain	GSK Investigational Site	Valencia
Taiwan	GSK Investigational Site	Changhua
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taoyuan
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkoknoi
Thailand	GSK Investigational Site	Khon Kaen
Thailand	GSK Investigational Site	Pathumthani
Thailand	GSK Investigational Site	Phitsanulok
Thailand	GSK Investigational Site	Ratchatewi
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
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	Poltava
Ukraine	GSK Investigational Site	Simferopol
Ukraine	GSK Investigational Site	Sumy
Ukraine	GSK Investigational Site	Uzhhorod
Ukraine	GSK Investigational Site	Zaporizhia
United Kingdom	GSK Investigational Site	Atherstone	Warwickshire
United Kingdom	GSK Investigational Site	Barry
United Kingdom	GSK Investigational Site	Bath	Somerset
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	Chesterfield	Derbyshire
United Kingdom	GSK Investigational Site	Doncaster
United Kingdom	GSK Investigational Site	Glasgow
United Kingdom	GSK Investigational Site	Kent
United Kingdom	GSK Investigational Site	Leicester
United Kingdom	GSK Investigational Site	Macclesfield
United Kingdom	GSK Investigational Site	Merseyside
United Kingdom	GSK Investigational Site	Newcastle Upon Tyne	Northumberland
United Kingdom	GSK Investigational Site	Penzance
United Kingdom	GSK Investigational Site	Peterborough
United Kingdom	GSK Investigational Site	Stockton on Tees
United Kingdom	GSK Investigational Site	Stoke on Trent
United Kingdom	GSK Investigational Site	Surrey
United States	GSK Investigational Site	Akron	Ohio
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Alhambra	California
United States	GSK Investigational Site	Allen	Texas
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	Ashland	Oregon
United States	GSK Investigational Site	Astoria	New York
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Aurora	Colorado
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Aventura	Florida
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Bangor	Maine
United States	GSK Investigational Site	Beavercreek	Ohio
United States	GSK Investigational Site	Belle Vernon	Pennsylvania
United States	GSK Investigational Site	Bellevue	Nebraska
United States	GSK Investigational Site	Bellevue	Nebraska
United States	GSK Investigational Site	Bellingham	Washington
United States	GSK Investigational Site	Bentonville	Arkansas
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	Blue Bell	Pennsylvania
United States	GSK Investigational Site	Boynton Beach	Florida
United States	GSK Investigational Site	Brick	New Jersey
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Buckley	Michigan
United States	GSK Investigational Site	Calhoun	Georgia
United States	GSK Investigational Site	Canoga Park	California
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Centennial	Colorado
United States	GSK Investigational Site	Centerville	Ohio
United States	GSK Investigational Site	Chandler	Arizona
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Cincinnati	Ohio
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	Columbia	South Carolina
United States	GSK Investigational Site	Columbus	Georgia
United States	GSK Investigational Site	Coral Gables	Florida
United States	GSK Investigational Site	Corsicana	Texas
United States	GSK Investigational Site	Crown Point	Indiana
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	Dayton	Ohio
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Destin	Florida
United States	GSK Investigational Site	Dickinson	Texas
United States	GSK Investigational Site	Dinuba	California
United States	GSK Investigational Site	Doral	Florida
United States	GSK Investigational Site	Dothan	Alaska
United States	GSK Investigational Site	Draper	Utah
United States	GSK Investigational Site	Duncanville	Texas
United States	GSK Investigational Site	Edison	New Jersey
United States	GSK Investigational Site	Edison	New Jersey
United States	GSK Investigational Site	El Paso	Texas
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Evergreen Park	Illinois
United States	GSK Investigational Site	Fall River	Massachusetts
United States	GSK Investigational Site	Fargo	North Dakota
United States	GSK Investigational Site	Fenton	Michigan
United States	GSK Investigational Site	Fort Mill	South Carolina
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Gainesville	Florida
United States	GSK Investigational Site	Gainesville	Florida
United States	GSK Investigational Site	Gainesville	Georgia
United States	GSK Investigational Site	Germantown	Tennessee
United States	GSK Investigational Site	Glenview	Illinois
United States	GSK Investigational Site	Gold River	California
United States	GSK Investigational Site	Granada Hills	California
United States	GSK Investigational Site	Great Falls	Montana
United States	GSK Investigational Site	Great Neck	New York
United States	GSK Investigational Site	Greenfield	Wisconsin
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Gresham	Oregon
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	Hialeah	Florida
United States	GSK Investigational Site	High Point	North Carolina
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	Huntington Beach	California
United States	GSK Investigational Site	Huntington Park	California
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Irving	Texas
United States	GSK Investigational Site	Johnson City	New York
United States	GSK Investigational Site	Johnstown	Pennsylvania
United States	GSK Investigational Site	Kansas City	Missouri
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	Killeen	Texas
United States	GSK Investigational Site	Kingwood	Texas
United States	GSK Investigational Site	La Crosse	Wisconsin
United States	GSK Investigational Site	Lake Oswego	Oregon
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	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	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	Rhode Island
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Live Oak	Texas
United States	GSK Investigational Site	Livingston	New Jersey
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	Louisville	Kentucky
United States	GSK Investigational Site	Lufkin	Texas
United States	GSK Investigational Site	Madison	Wisconsin
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	Melbourne	Florida
United States	GSK Investigational Site	Metairie	Louisiana
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	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami Lakes	Florida
United States	GSK Investigational Site	Midlothian	Virginia
United States	GSK Investigational Site	Midlothian	Virginia
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Missoula	Montana
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Montgomery	Alabama
United States	GSK Investigational Site	Murray	Utah
United States	GSK Investigational Site	Napa	California
United States	GSK Investigational Site	Naples	Florida
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Port Richey	Florida
United States	GSK Investigational Site	Newburgh	New York
United States	GSK Investigational Site	Newport Beach	California
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	North Syracuse	New York
United States	GSK Investigational Site	Northfield	New Jersey
United States	GSK Investigational Site	Oakland	California
United States	GSK Investigational Site	Ocala	Florida
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	Orange	California
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	Owensboro	Kentucky
United States	GSK Investigational Site	Pace	Florida
United States	GSK Investigational Site	Palmdale	California
United States	GSK Investigational Site	Paramount	California
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Pensacola	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plymouth	Minnesota
United States	GSK Investigational Site	Ponte Vedra Beach	Florida
United States	GSK Investigational Site	Port Gibson	Mississippi
United States	GSK Investigational Site	Puyallup	Washington
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	Riverside	California
United States	GSK Investigational Site	Rolling Hills Est.	California
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	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 Antonio	Texas
United States	GSK Investigational Site	San Marino	California
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	Scottsboro	Alabama
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Sealy	Texas
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	Shreveport	Louisiana
United States	GSK Investigational Site	Silver Spring	Maryland
United States	GSK Investigational Site	Somerville	New Jersey
United States	GSK Investigational Site	Staten Island	New York
United States	GSK Investigational Site	Stevensville	Michigan
United States	GSK Investigational Site	Stockbridge	Georgia
United States	GSK Investigational Site	Sugar Land	Texas
United States	GSK Investigational Site	Sugar Land	Texas
United States	GSK Investigational Site	Sylvania	Ohio
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tampa	Florida
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	Tucson	Arizona
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	Utica	New York
United States	GSK Investigational Site	Verona	New Jersey
United States	GSK Investigational Site	Virginia Beach	Virginia
United States	GSK Investigational Site	Waco	Texas
United States	GSK Investigational Site	Waco	Texas
United States	GSK Investigational Site	Warrensburg	Missouri
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Waterbury	Connecticut
United States	GSK Investigational Site	Waxahachie	Texas
United States	GSK Investigational Site	Wellington	Florida
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	West Covina	California
United States	GSK Investigational Site	West Des Moines	Iowa
United States	GSK Investigational Site	West Sacramento	California
United States	GSK Investigational Site	Westfield	New York
United States	GSK Investigational Site	Wheeling	Ohio
United States	GSK Investigational Site	White Marsh	Maryland
United States	GSK Investigational Site	Woods Cross	Utah
United States	GSK Investigational Site	Ypsilanti	Michigan
United States	GSK Investigational Site	Zanesville	Ohio

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,  Germany,  Hungary,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  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. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.	From Day 1 up to 6 months
Primary	Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period	Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint.	From Day 1 up to 6 months
Secondary	Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.	Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.	From Day 1 up to 6 months
Secondary	Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period	Intubation is defined as endotracheal intubation with ventilation (mechanical or by hand). The number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period are presented.	From Day 1 up to 6 months
Secondary	Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period	Hospitalization is defined as a >=24-hour stay as an inpatient or in an observation ward. The number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period are presented.	From Day 1 up to 6 months
Secondary	Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period	An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented.	From Day 1 up to 6 months
Secondary	Percentage of Rescue-free Days Over the 6-month Study Treatment Period	Rescue-free days were days without use of rescue albuterol/salbutamol (other than pre-exercise treatment) over the 6-month study treatment period. The mean percentages of rescue-free days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.	From Day 1 up to 6 months
Secondary	Percentage of Asthma Control Days Over the 6-month Study Treatment Period	An asthma control day is one on which rescue albuterol/salbutamol use was recorded as 0, no night time awakenings were recorded, no asthma exacerbations were recorded, no work, school, or daycare days were missed by caregiver or participant due to asthma, coughing symptom score was <=1 and wheezing symptom score was 0. The mean percentages of asthma control days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.	From Day 1 up to 6 months

External Links

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