A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD)

PHASE2TerminatedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

October 16, 2017

Primary Completion Date

November 15, 2018

Study Completion Date

November 15, 2018

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Danirixin 35 mg tablets

Danirixin 35 mg (as hydrobromide hemihydrate salt) is a white film coated oval shaped tablet. It will be provided in a labeled high-density polyethylene (HDPE) bottle with desiccant.

DRUG

Placebo

Placebo is a white film coated oval shaped tablet. It will be provided in a labeled HDPE bottle with desiccant.

DEVICE

Metered dose inhaler (MDI) sensor device

MDI sensor devices will be fitted onto rescue medication MDI devices to electronically record rescue medication usage.

DRUG

Rescue medication

Subjects may continue to use rescue medication(s) via their usual route. Allowed medications are: short acting beta agonists (SABA) (e.g., albuterol/salbutamol); short acting muscarinic antagonists (SAMA) (e.g., ipratropium); short acting combination (SABA/SAMA) bronchodilators, (e.g. Duoneb, Combivent)

Trial Locations (11)

15213

GSK Investigational Site, Pittsburgh

19140

GSK Investigational Site, Philadelphia

21224

GSK Investigational Site, Baltimore

35294

GSK Investigational Site, Birmingham

52243

GSK Investigational Site, Iowa City

55101

GSK Investigational Site, Saint Paul

77030

GSK Investigational Site, Houston

80206

GSK Investigational Site, Denver

90502

GSK Investigational Site, Torrance

92103-8415

GSK Investigational Site, San Diego

48109-5360

GSK Investigational Site, Ann Arbor

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY