Clinical trial NCT01462344: 6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: pediatric
ADVAIR
FLOVENT
asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2011-10-31
Enrollment: 6250
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
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 children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

Detailed 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.

Eligibility criteria: 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.

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 6 months
measure: Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period
timeFrame: From Day 1 up to 6 months
Secondary outcomes:
measure: Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.
timeFrame: From Day 1 up to 6 months
measure: Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period
timeFrame: From Day 1 up to 6 months
measure: Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period
timeFrame: From Day 1 up to 6 months
measure: Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period
timeFrame: From Day 1 up to 6 months
measure: Percentage of Rescue-free Days Over the 6-month Study Treatment Period
timeFrame: From Day 1 up to 6 months
measure: Percentage of Asthma Control Days Over the 6-month Study Treatment Period
timeFrame: From Day 1 up to 6 months
Other outcomes:
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city: Midlothian
country: United States
facility: GSK Investigational Site
state: Virginia
city: Midlothian
country: United States
facility: GSK Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: GSK Investigational Site
state: Virginia
city: Bellingham
country: United States
facility: GSK Investigational Site
state: Washington
city: Puyallup
country: United States
facility: GSK Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
city: Greenfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: La Crosse
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Nueve de Julio
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Concepcion del Uruguay
country: Argentina
facility: GSK Investigational Site
state: Entre Ríos
city: Parana
country: Argentina
facility: GSK Investigational Site
state: Entre Ríos
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Capital Federal
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Lanús
country: Argentina
facility: GSK Investigational Site
city: San Miguel de Tucuman
country: Argentina
facility: GSK Investigational Site
city: Westmead
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Auchenflower
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Subiaco
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Parkville
country: Australia
facility: GSK Investigational Site
city: Randwick
country: Australia
facility: GSK Investigational Site
city: Bregenz
country: Austria
facility: GSK Investigational Site
city: Feldkirch
country: Austria
facility: GSK Investigational Site
city: Wien
country: Austria
facility: GSK Investigational Site
city: Antwerpen
country: Belgium
facility: GSK Investigational Site
city: Brussels
country: Belgium
facility: GSK Investigational Site
city: Gembloux
country: Belgium
facility: GSK Investigational Site
city: Hamois (Natoye)
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Blagoevgrad
country: Bulgaria
facility: GSK Investigational Site
city: Pleven
country: Bulgaria
facility: GSK Investigational Site
city: Plovdiv
country: Bulgaria
facility: GSK Investigational Site
city: Ruse
country: Bulgaria
facility: GSK Investigational Site
city: Ruse
country: Bulgaria
facility: GSK Investigational Site
city: Sevlievo
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Stara Zagora
country: Bulgaria
facility: GSK Investigational Site
city: Varna
country: Bulgaria
facility: GSK Investigational Site
city: Varna
country: Bulgaria
facility: GSK Investigational Site
city: Veliko Tarnovo
country: Bulgaria
facility: GSK Investigational Site
city: Vidin
country: Bulgaria
facility: GSK Investigational Site
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Burlington
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Santiago
country: Chile
facility: GSK Investigational Site
city: Valdivia
country: Chile
facility: GSK Investigational Site
city: Viña del Mar
country: Chile
facility: GSK Investigational Site
city: Medellin
country: Colombia
facility: GSK Investigational Site
city: Cakovec
country: Croatia
facility: GSK Investigational Site
city: Dubrovnik
country: Croatia
facility: GSK Investigational Site
city: Jastrebarsko
country: Croatia
facility: GSK Investigational Site
city: Rijeka
country: Croatia
facility: GSK Investigational Site
city: Split
country: Croatia
facility: GSK Investigational Site
city: Zagreb
country: Croatia
facility: GSK Investigational Site
city: Brno
country: Czechia
facility: GSK Investigational Site
city: Brno
country: Czechia
facility: GSK Investigational Site
city: Ceska Lipa
country: Czechia
facility: GSK Investigational Site
city: Olomouc
country: Czechia
facility: GSK Investigational Site
city: Praha 4
country: Czechia
facility: GSK Investigational Site
city: Bruchsal
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Fuerth
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hoechstadt
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Weissenhorn
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Bad Pyrmont
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bad Lippspringe
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Detmold
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Hagen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kleve-Materborn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Neuss
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Telgte
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Teuchern
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Geesthacht
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Reinfeld
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Baja
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Miskolc
country: Hungary
facility: GSK Investigational Site
city: Nagykanizsa
country: Hungary
facility: GSK Investigational Site
city: Rackeve
country: Hungary
facility: GSK Investigational Site
city: Szekszárd
country: Hungary
facility: GSK Investigational Site
city: Törökbálint
country: Hungary
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Brescia
country: Italy
facility: GSK Investigational Site
city: Messina
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Palermo
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Sesto San Giovanni
country: Italy
facility: GSK Investigational Site
city: Cheongju-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Pusan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Tukums
country: Latvia
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Utena
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Ipoh
country: Malaysia
facility: GSK Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: GSK Investigational Site
city: Kuching
country: Malaysia
facility: GSK Investigational Site
city: Seremban, Negeri Sembilan
country: Malaysia
facility: GSK Investigational Site
city: Sibu
country: Malaysia
facility: GSK Investigational Site
city: Sungai Buloh
country: Malaysia
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
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: Miraflores
country: Peru
facility: GSK Investigational Site
state: Lima
city: San Martin de Porres
country: Peru
facility: GSK Investigational Site
state: Lima
city: Santiago de Surco
country: Peru
facility: GSK Investigational Site
state: Lima
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
country: Peru
facility: GSK Investigational Site
city: Dasmariñas, Cavite
country: Philippines
facility: GSK Investigational Site
city: Davao
country: Philippines
facility: GSK Investigational Site
city: Pulilan
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Cieszyn
country: Poland
facility: GSK Investigational Site
city: Dębica
country: Poland
facility: GSK Investigational Site
city: Gdanska
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Jelenia Gora
country: Poland
facility: GSK Investigational Site
city: Karpacz
country: Poland
facility: GSK Investigational Site
city: Koszalin
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
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: Lublin
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Rzeszow
country: Poland
facility: GSK Investigational Site
city: Sandomierz
country: Poland
facility: GSK Investigational Site
city: Skarżysko-Kamienna
country: Poland
facility: GSK Investigational Site
city: Skierniewice
country: Poland
facility: GSK Investigational Site
city: Szczecin
country: Poland
facility: GSK Investigational Site
city: Szczecin
country: Poland
facility: GSK Investigational Site
city: Tarnow
country: Poland
facility: GSK Investigational Site
city: Warszawa
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: Bucharest
country: Romania
facility: GSK Investigational Site
city: Sibiu
country: Romania
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: Nizhniy Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
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: St. Petersburg
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: 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: Cacak
country: Serbia
facility: GSK Investigational Site
city: Nis
country: Serbia
facility: GSK Investigational Site
city: Novi Sad
country: Serbia
facility: GSK Investigational Site
city: Uzice
country: Serbia
facility: GSK Investigational Site
city: Martin
country: Slovakia
facility: GSK Investigational Site
city: Nitra
country: Slovakia
facility: GSK Investigational Site
city: Trnava
country: Slovakia
facility: GSK Investigational Site
city: Welkom
country: South Africa
facility: GSK Investigational Site
state: Free State
city: Benoni
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: 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: Durban
country: South Africa
facility: GSK Investigational Site
city: Middelburg
country: South Africa
facility: GSK Investigational Site
city: Paarl
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: Thabazimbi
country: South Africa
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Burgos
country: Spain
facility: GSK Investigational Site
city: Madrid
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: Valencia
country: Spain
facility: GSK Investigational Site
city: Changhua
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
city: Bangkoknoi
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Khon Kaen
country: Thailand
facility: GSK Investigational Site
city: Pathumthani
country: Thailand
facility: GSK Investigational Site
city: Phitsanulok
country: Thailand
facility: GSK Investigational Site
city: Ratchatewi
country: Thailand
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
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: Poltava
country: Ukraine
facility: GSK Investigational Site
city: Simferopol
country: Ukraine
facility: GSK Investigational Site
city: Sumy
country: Ukraine
facility: GSK Investigational Site
city: Uzhhorod
country: Ukraine
facility: GSK Investigational Site
city: Zaporizhia
country: Ukraine
facility: GSK Investigational Site
city: Chesterfield
country: United Kingdom
facility: GSK Investigational Site
state: Derbyshire
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
state: Glamorgan
city: Newcastle Upon Tyne
country: United Kingdom
facility: GSK Investigational Site
state: Northumberland
city: Bath
country: United Kingdom
facility: GSK Investigational Site
state: Somerset
city: Brighton
country: United Kingdom
facility: GSK Investigational Site
state: Sussex East
city: Atherstone
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: Barry
country: United Kingdom
facility: GSK Investigational Site
city: Bexhill-on-Sea
country: United Kingdom
facility: GSK Investigational Site
city: Doncaster
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: Macclesfield
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: Peterborough
country: United Kingdom
facility: GSK Investigational Site
city: Stockton on Tees
country: United Kingdom
facility: GSK Investigational Site
city: Stoke on Trent
country: United Kingdom
facility: GSK Investigational Site
city: Surrey
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lee LA, Pedersen S, Pascoe SJ, Szefler SJ, Lenney W. No dose effect observed with chronic fluticasone propionate on growth velocity in children. Pediatr Allergy Immunol. 2021 Feb;32(2):377-381. doi: 10.1111/pai.13378. Epub 2020 Oct 26. No abstract available.
citation: Stempel DA, Szefler SJ, Pedersen S, Zeiger RS, Yeakey AM, Lee LA, Liu AH, Mitchell H, Kral KM, Raphiou IH, Prillaman BA, Buaron KS, Yun Kirby S, Pascoe SJ; VESTRI Investigators. Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma. N Engl J Med. 2016 Sep 1;375(9):840-9. doi: 10.1056/NEJMoa1606356.