Effectiveness and Safety of BIO-11006 Inhalation Solution to Treat the Overproduction of Mucus and Inflammation in COPD

PHASE2CompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
COPDChronic Obstructive Pulmonary Disease
Interventions
DRUG

BIO-11006 Inhalation Solution

75 mg of BIO-11006 administered once per day for 21 days by nebulizer

DRUG

BIO-11006 Inhalation Solution

150 mg of BIO-11006 administered once per day for 21 days by nebulizer

DRUG

BIO-11006 Inhalation Solution

75 mg of BIO-11006 administered twice per day for 21 days by nebulizer

DRUG

Placebo

Placebo given once daily for 21 days by nebulizer

DRUG

BIO-11006

125 mg BIO-11006 given twice per day for 21 days by nebulizer

Trial Locations (14)

27103

Southeastern Research Center, LLC, Winston-Salem

27607

North Carolina Clinical Research, Raleigh

27704

Duke University Medical Center, Durham

29303

Spartanburg Medical Research, Spartanburg

30033

Southeastern Lung Care, Decatur

32789

Florida Pulmonary Research Institute, LLC, Winter Park

33744

Bay Pines VA Heatlhcare System, Bay Pines

40202

University of Louisville, Louisville

77030

Baylor College of Medicine, Houston

Michael E. DeBakey VAMC, Houston

78229

Diagnostics Research Group, San Antonio

85306

Pulmonary Associates, Glendale

89502

VA Sierra Nevada Health Care System, Reno

91343

Greater Los Angeles Healthcare System, Los Angeles

Sponsors
All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

BioMarck Pharmaceuticals, Ltd.

INDUSTRY