Clinical trial NCT01475721: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: ADVAIR
Asthma
safety
FLOVENT
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2011-11-21
Enrollment: 11751
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: From Day 1 up to 26 weeks
measure: Number of Participants Experiencing at Least One Asthma Exacerbation
timeFrame: From Day 1 up to 26 weeks
Secondary outcomes:
measure: Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death
timeFrame: From Day 1 up to 26 weeks
measure: Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation
timeFrame: From Day 1 up to 26 weeks
measure: Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours
timeFrame: From Day 1 up to 26 weeks
Other outcomes:
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facility: GSK Investigational Site
state: Rhode Island
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Sesto San Giovanni
country: Italy
facility: GSK Investigational Site
city: Bucheon-si,
country: Korea, Republic of
facility: GSK Investigational Site
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country: Korea, Republic of
facility: GSK Investigational Site
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country: Korea, Republic of
facility: GSK Investigational Site
city: Chuncheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Gwangju
country: Korea, Republic of
facility: GSK Investigational Site
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country: Korea, Republic of
facility: GSK Investigational Site
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country: Korea, Republic of
facility: GSK Investigational Site
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country: Korea, Republic of
facility: GSK Investigational Site
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country: Korea, Republic of
facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Alor Setar
country: Malaysia
facility: GSK Investigational Site
city: Kota Bharu
country: Malaysia
facility: GSK Investigational Site
city: Kuala Pilah
country: Malaysia
facility: GSK Investigational Site
city: Selangor
country: Malaysia
facility: GSK Investigational Site
city: Sungai Buloh
country: Malaysia
facility: GSK Investigational Site
city: Aguascalientes, Ags
country: Mexico
facility: GSK Investigational Site
state: Aguascalientes
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: Huixquilucan
country: Mexico
facility: GSK Investigational Site
city: Monterrey
country: Mexico
facility: GSK Investigational Site
city: Monterrey
country: Mexico
facility: GSK Investigational Site
city: Zapopan
country: Mexico
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: San Borja, Lima
country: Peru
facility: GSK Investigational Site
city: Dasmariñas, Cavite
country: Philippines
facility: GSK Investigational Site
city: Davao
country: Philippines
facility: GSK Investigational Site
city: Las Pinas
country: Philippines
facility: GSK Investigational Site
city: Los Banos
country: Philippines
facility: GSK Investigational Site
city: Pulilan
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Bielsko-Biala
country: Poland
facility: GSK Investigational Site
city: Brzesko
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Bystra
country: Poland
facility: GSK Investigational Site
city: Cieszyn
country: Poland
facility: GSK Investigational Site
city: Dębica
country: Poland
facility: GSK Investigational Site
city: Elblag
country: Poland
facility: GSK Investigational Site
city: Gdanska
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Glucholazy
country: Poland
facility: GSK Investigational Site
city: Jelenia Gora
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Libiaz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lubin
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Radomsko
country: Poland
facility: GSK Investigational Site
city: Ruda Slaska
country: Poland
facility: GSK Investigational Site
city: Rudka
country: Poland
facility: GSK Investigational Site
city: Rzeszow
country: Poland
facility: GSK Investigational Site
city: Sandomierz
country: Poland
facility: GSK Investigational Site
city: Sopot
country: Poland
facility: GSK Investigational Site
city: Szczecin
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wodzislaw Slaski
country: Poland
facility: GSK Investigational Site
city: Wolomin
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Zabrze
country: Poland
facility: GSK Investigational Site
city: Zabrze
country: Poland
facility: GSK Investigational Site
city: Zgierz
country: Poland
facility: GSK Investigational Site
city: Brasov
country: Romania
facility: GSK Investigational Site
city: Cluj-Napoca
country: Romania
facility: GSK Investigational Site
city: Sibiu
country: Romania
facility: GSK Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Kemerovo
country: Russian Federation
facility: GSK Investigational Site
city: Kirov
country: Russian Federation
facility: GSK Investigational Site
city: Krasnodar
country: Russian Federation
facility: GSK Investigational Site
city: Krasnoyarsk
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: Orenburg
country: Russian Federation
facility: GSK Investigational Site
city: Pyatigorsk
country: Russian Federation
facility: GSK Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: GSK Investigational Site
city: Ryazan
country: Russian Federation
facility: GSK Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Voronezh
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Belgrade
country: Serbia
facility: GSK Investigational Site
city: Belgrade
country: Serbia
facility: GSK Investigational Site
city: Kosice
country: Slovakia
facility: GSK Investigational Site
city: Kralovsky Chlmec
country: Slovakia
facility: GSK Investigational Site
city: Levice
country: Slovakia
facility: GSK Investigational Site
city: Martin
country: Slovakia
facility: GSK Investigational Site
city: Sturovo
country: Slovakia
facility: GSK Investigational Site
city: Trnava
country: Slovakia
facility: GSK Investigational Site
city: Port Elizabeth
country: South Africa
facility: GSK Investigational Site
state: Eastern Cape
city: Cape Town
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Eloffsdal
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Krugersdorp
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Bellville
country: South Africa
facility: GSK Investigational Site
city: Benoni
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Claremont
country: South Africa
facility: GSK Investigational Site
city: Die Wilgers
country: South Africa
facility: GSK Investigational Site
city: Durban
country: South Africa
facility: GSK Investigational Site
city: Durban
country: South Africa
facility: GSK Investigational Site
city: Gatesville
country: South Africa
facility: GSK Investigational Site
city: Middelburg
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Soweto
country: South Africa
facility: GSK Investigational Site
city: Thabazimbi
country: South Africa
facility: GSK Investigational Site
city: Welkom
country: South Africa
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Basurto/Bilbao
country: Spain
facility: GSK Investigational Site
city: Burgos
country: Spain
facility: GSK Investigational Site
city: Canet De Mar - Barcelona
country: Spain
facility: GSK Investigational Site
city: Cádiz
country: Spain
facility: GSK Investigational Site
city: Elche
country: Spain
facility: GSK Investigational Site
city: Illescas-Toledo
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: Lleida
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Majadahonda (Madrid)
country: Spain
facility: GSK Investigational Site
city: Mataro
country: Spain
facility: GSK Investigational Site
city: Pozuelo De Alarcón/Madrid
country: Spain
facility: GSK Investigational Site
city: Sabadell (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Sagunto/Valencia
country: Spain
facility: GSK Investigational Site
city: Sant Boi de Llobregat
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Tarrasa, Barcelona
country: Spain
facility: GSK Investigational Site
city: Torrelavega
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valladolid
country: Spain
facility: GSK Investigational Site
city: Vic (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Keelung
country: Taiwan
facility: GSK Investigational Site
city: Koahsiung
country: Taiwan
facility: GSK Investigational Site
city: Putzu
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Cherkassy
country: Ukraine
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Donetsk
country: Ukraine
facility: GSK Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kiev
country: Ukraine
facility: GSK Investigational Site
city: Kryvyi Rih
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Lviv
country: Ukraine
facility: GSK Investigational Site
city: Odesa
country: Ukraine
facility: GSK Investigational Site
city: Odesa
country: Ukraine
facility: GSK Investigational Site
city: Odesa
country: Ukraine
facility: GSK Investigational Site
city: Poltava
country: Ukraine
facility: GSK Investigational Site
city: Simferopol
country: Ukraine
facility: GSK Investigational Site
city: Sumy
country: Ukraine
facility: GSK Investigational Site
city: Sumy
country: Ukraine
facility: GSK Investigational Site
city: Sumy
country: Ukraine
facility: GSK Investigational Site
city: Ternopil
country: Ukraine
facility: GSK Investigational Site
city: Vinnytsia
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: GSK Investigational Site
city: Zhytomyr
country: Ukraine
facility: GSK Investigational Site
city: Bedford
country: United Kingdom
facility: GSK Investigational Site
state: Bedfordshire
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
state: Glamorgan
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Greater Manchester
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
state: Merseyside
city: Bath
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Brighton
country: United Kingdom
facility: GSK Investigational Site
state: Sussex East
city: Barry
country: United Kingdom
facility: GSK Investigational Site
city: Bexhill-on-Sea
country: United Kingdom
facility: GSK Investigational Site
city: Chertsey, Surrey
country: United Kingdom
facility: GSK Investigational Site
city: Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Kent
country: United Kingdom
facility: GSK Investigational Site
city: Leicester
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Merseyside
country: United Kingdom
facility: GSK Investigational Site
city: Penzance
country: United Kingdom
facility: GSK Investigational Site
city: Stoke on Trent
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Busse W, Stempel D, Aggarwal B, Boucot I, Forth R, Raphiou I, Rabe KF, Reddel HK. Insights from the AUSTRI study on reliever use before and after asthma exacerbations. J Allergy Clin Immunol Pract. 2022 Jul;10(7):1916-1918.e2. doi: 10.1016/j.jaip.2022.03.029. Epub 2022 Apr 9. No abstract available.
citation: Stempel DA, Raphiou IH, Kral KM, Yeakey AM, Emmett AH, Prazma CM, Buaron KS, Pascoe SJ; AUSTRI Investigators. Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone. N Engl J Med. 2016 May 12;374(19):1822-30. doi: 10.1056/NEJMoa1511049. Epub 2016 Mar 6.