Effect of Fluticasone Furoate Inhalation Powder on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

October 9, 2015

Primary Completion Date

June 20, 2016

Study Completion Date

June 21, 2016

Conditions
Asthma
Interventions
DRUG

FF

FF will be provided as a dry powder inhaler with 30 doses per device, each containing 50 mcg of FF as a dry white powder per blister, to be inhaled orally via ELLIPTA.

DRUG

Placebo

Placebo will be provided as dry powder inhaler with 30 doses per device, each containing placebo as a dry white powder per blister, to be inhaled orally via ELLIPTA.

DRUG

Montelukast

Montelukast will be provided as 4 mg and 5 mg chewable tablets.

DRUG

Albuterol/Salbutamol

Albuterol/Salbutamol will be provided as inhalation aerosol.

Trial Locations (17)

1055

GSK Investigational Site, Middelburg

7500

GSK Investigational Site, Panorama

7530

GSK Investigational Site, Bellville

27607

GSK Investigational Site, Raleigh

29118

GSK Investigational Site, Orangeburg

33030

GSK Investigational Site, Homestead

33135

GSK Investigational Site, Miami

33142

GSK Investigational Site, Miami

33175

GSK Investigational Site, Miami

72211

GSK Investigational Site, Little Rock

73112

GSK Investigational Site, Oklahoma City

73120

GSK Investigational Site, Oklahoma City

77055

GSK Investigational Site, Houston

91801

GSK Investigational Site, Alhambra

92626

GSK Investigational Site, Costa Mesa

92647

GSK Investigational Site, Huntington Beach

92663

GSK Investigational Site, Newport Beach

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY