A Safety and Efficacy Study of Intranasal GSK2245035 in Adults With Allergic Asthma

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 21, 2019

Primary Completion Date

December 23, 2019

Study Completion Date

December 23, 2019

Conditions
Asthma
Interventions
DRUG

GSK2245035

GSK2245035 will be administered weekly once as a nasal spray solution with dosing strength of 10 ng per actuation. GSK2245035 will be available as a saline formulation, preserved with benzalkonium chloride and disodium edetate in an amber glass bottle fitted with a screw-fit atomizing pump.

DRUG

Placebo

Placebo will be administered weekly once as a nasal spray solution. Placebo will be available as a saline formulation, preserved with benzalkonium chloride and disodium edetate in an amber glass bottle fitted with a screw-fit atomizing pump.

DRUG

FP-DPI

FP will be administered using Diskus inhaler with dosing strengths of 500, 250, 100, 50 µg twice daily per actuation.

DRUG

Albuterol/Salbutamol

Albuterol/Salbutamol MDI will be administered for symptom relief from screening to the end of the study.

OTHER

eDairy

Subjects will record all the alerts indicative of worsening of asthma in eDairy.

OTHER

ACQ-6

ACQ-6 will include six questions which enquire about the frequency and/or severity of symptoms. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/limitation) scale.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY