Safety and Efficacy Study of Losmapimod (GW856553) in Frequently Exacerbating Participants With Chronic Obstructive Pulmonary Disease (COPD)

PHASE2CompletedINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

December 9, 2014

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Losmapimod tablets

Losmapimod tablets will be provided as 15 mg strength in a formulation containing lactose. Administered orally, twice daily approximately 12 hours apart and with food and water for the duration of the treatment period. Participants will be instructed to take their medication with a full glass of water twice-daily within 30 minutes after meals for the duration of their treatment period.

DRUG

Placebo tablets

Placebo tablets will be provided in a formulation containing lactose and visually matching the losmapimod tablets. Administered orally, twice daily approximately 12 hours apart and with food and water for the duration of the treatment period. Participants will be instructed to take their medication with a full glass of water twice-daily within 30 minutes after meals for the duration of their treatment period

DRUG

Salbutamol MDI

Salbutamol MDI will be provided as a rescue medication.

Trial Locations (36)

1233

GSK Investigational Site, Sofia

1336

GSK Investigational Site, Sofia

2260

GSK Investigational Site, Svoge

4000

GSK Investigational Site, San Miguel de Tucumán

5500

GSK Investigational Site, Mendoza

6400

GSK Investigational Site, Dimitrovgrad

10119

GSK Investigational Site, Berlin

13581

GSK Investigational Site, Berlin

14467

GSK Investigational Site, Potsdam

20354

GSK Investigational Site, Hamburg

22763

GSK Investigational Site, Hamburg

28223

GSK Investigational Site, Pozuelo de Alarcón/Madrid

30173

GSK Investigational Site, Hanover

46014

GSK Investigational Site, Valencia

48903

GSK Investigational Site, (Barakaldo) Vizcaya

51069

GSK Investigational Site, Cologne

52349

GSK Investigational Site, Düren

56068

GSK Investigational Site, Koblenz

60389

GSK Investigational Site, Frankfurt am Main

3465584

GSK Investigational Site, Talca

8380453

GSK Investigational Site, Santiago

8910131

GSK Investigational Site, Santiago

C1426ABP

GSK Investigational Site, Buenos Aires

M5500CCG

GSK Investigational Site, Mendoza

04266-010

GSK Investigational Site, São Paulo

066 01

GSK Investigational Site, Humenné

058 01

GSK Investigational Site, Poprad

052 01

GSK Investigational Site, Spišská Nová Ves

927 01

GSK Investigational Site, Šaľa

952 01

GSK Investigational Site, Vráble

403-720

GSK Investigational Site, Incheon

130-709

GSK Investigational Site, Seoul

03004

GSK Investigational Site, Alicante

08006

GSK Investigational Site, Barcelona

08036

GSK Investigational Site, Barcelona

08907

GSK Investigational Site, L'Hospitalet de Llobregat. Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02299375 - Safety and Efficacy Study of Losmapimod (GW856553) in Frequently Exacerbating Participants With Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter | Biotech Hunter