Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year

PHASE4CompletedINTERVENTIONAL
Enrollment

477

Participants

Timeline

Start Date

July 10, 2017

Primary Completion Date

April 9, 2021

Study Completion Date

June 4, 2021

Conditions
Asthma
Interventions
DRUG

Fluticasone furoate

Fluticasone furoate will be supplied as 50 mcg per blister dry white powder for inhalation using ELLIPTA inhaler.

DRUG

Placebo

Placebo will be supplied as dry white powder Lactose for inhalation using ELLIPTA inhaler.

DRUG

Montelukast

Montelukast will be supplied as 4 mg chewable tablet (5 year old subjects) and as 5 mg chewable tablet (\>=6 year old subjects)

DRUG

Short Acting Beta 2 Agonist

Albuterol/salbutamol will be supplied as inhalation aerosol or nebulizer.

Trial Locations (54)

1055

GSK Investigational Site, Middelburg

7500

GSK Investigational Site, Cape Town

7530

GSK Investigational Site, Bellville

7700

GSK Investigational Site, Cape Town

7708

GSK Investigational Site, Cape Town

15241

GSK Investigational Site, Pittsburgh

15879

GSK Investigational Site, Bialystok

27607

GSK Investigational Site, Raleigh

30501

GSK Investigational Site, Gainesville

33030

GSK Investigational Site, Homestead

33134

GSK Investigational Site, Miami

33135

GSK Investigational Site, Miami

33142

GSK Investigational Site, Miami

33175

GSK Investigational Site, Miami

33470

GSK Investigational Site, Loxahatchee Groves

33710

GSK Investigational Site, St. Petersburg

48197

GSK Investigational Site, Ypsilanti

68123

GSK Investigational Site, Bellevue

72205

GSK Investigational Site, Little Rock

76712

GSK Investigational Site, Waco

78230

GSK Investigational Site, San Antonio

92648

GSK Investigational Site, Huntington Beach

97504

GSK Investigational Site, Medford

119991

GSK Investigational Site, Moscow

129110

GSK Investigational Site, Moscow

150003

GSK Investigational Site, Yaroslavl

191025

GSK Investigational Site, Saint Petersburg

192212

GSK Investigational Site, Saint Petersburg

194100

GSK Investigational Site, Saint Petersburg

196191

GSK Investigational Site, Saint Petersburg

196240

GSK Investigational Site, Saint Petersburg

196657

GSK Investigational Site, Saint Petersburg

394036

GSK Investigational Site, Voronezh

400001

GSK Investigational Site, ClujNapoca

500091

GSK Investigational Site, Brasov

500283

GSK Investigational Site, Brasov

547530

GSK Investigational Site, Sangiorgiu de Mures

630091

GSK Investigational Site, Novosibirsk

29118-2040

GSK Investigational Site, Orangeburg

C1122AAK

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

B1824KAJ

GSK Investigational Site, Lanús

C1121ABE

GSK Investigational Site, Buenos Aires

C1425BEN

GSK Investigational Site, Buenos Aires

M5500CCG

GSK Investigational Site, Mendoza

15-430

GSK Investigational Site, Bialystok

85-796

GSK Investigational Site, Bydgoszcz

80-405

GSK Investigational Site, Gdansk-Wrzeszcz

31-011

GSK Investigational Site, Krakow

20-093

GSK Investigational Site, Lublin

26-110

GSK Investigational Site, Skarżysko-Kamienna

70-382

GSK Investigational Site, Szczecin

33-100

GSK Investigational Site, Tarnów

020395

GSK Investigational Site, Bucharest

634 050

GSK Investigational Site, Tomsk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY