NCT01426009 - Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study | Biotech Hunter

Enrollment

140

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

DRUG

EP-101 via nebulizer (eFlow®) 25 ug

EP-101 (25 ug ) Dose 1 administered once daily for 7 days

DRUG

EP-101 via nebulizer (eFlow®) 50 ug

EP-101 (50 ug ) administered once daily for 7 days

DRUG

EP-101 via nebulizer (eFlow®) 100 ug

EP-101 (100ug) administered once daily for 7 days

DRUG

Placebo EP-101

Placebo EP-101 administered once daily for 7 days

DRUG

Tiotropium bromide via (Spiriva® Handihaler®)

Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI

DRUG

Ipratropium bromide Inhalation Solution via Handihaler® DPI

Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer

DRUG

EP-101 via nebulizer (eFlow®) 200 ug

EP-101 (200) ug administered once daily for 7 days

Trial Locations (11)

27607

Elevation Investigational Site, Raleigh

28207

Elevation Investigational Site, Charlotte

29303

Elevation Investigational Site, Spartanburg

32720

Elevation Investigational Site, DeLand

42431

Elevation Investigational SIte, Madisonville

85006

Elevation Investigational Site, Phoenix

90048

Elevation Investigational Site, Los Angeles

97504

Elevation Investigational Site, Medford

98418

Elevation Investigational Site, Tacoma

02747

Elevation Investigational Site, North Dartmouth

M21 8AD

Elevation Investigational Site, Manchester

All Listed Sponsors

lead

Sunovion Respiratory Development Inc.

INDUSTRY