Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects

PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

February 9, 2017

Primary Completion Date

December 20, 2018

Study Completion Date

December 20, 2018

Conditions
Asthma
Interventions
DRUG

Fluticasone furoate (FF) Dry Powder Inhaler

Dry inhalation powder 25 mcg, 100 mcg, and 200 mcg per blister strip will be administered using ELLIPTA for both treatment periods

DRUG

Fluticasone propionate (FP) Dry Powder Inhaler

Dry Inhalation powder 50 mcg, 100 mcg, 250 mcg, and 500 mcg per blister strip will be administered using DISKUS for both treatment periods

DRUG

Budesonide (BUD) Turbuhaler

Budesonide comprises white to off-white rounded granules, which disintegrate to a fine powder upon slight pressure, will be administered using Turbuhaler for both treatment periods.

DRUG

Placebo (ELLIPTA or DISKUS)

Lactose dry powder inhaler will be administered using ELLIPTA or DISKUS for both treatment periods.

Trial Locations (3)

14050

GSK Investigational Site, Berlin

HA1 3UJ

GSK Investigational Site, Harrow

M23 9QZ

GSK Investigational Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY