Effectiveness and Safety of BIO-11006 Inhalation Solution to Treat the Overproduction of Mucus and Inflammation in COPD
BREATH-1
A Phase 2a, Double Blind, Placebo Controlled, Multicenter, Dose Escalation Study to Evaluate the Safety and Efficacy of BIO 11006 Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
2 other identifiers
interventional
172
1 country
14
Brief Summary
The symptoms associated with COPD include overproduction of mucus and inflammation in the lungs. Overproduction of mucus results in impaired lung function and it encourages bacterial growth and associated COPD exacerbations. Therefore, a treatment that inhibits mucus overproduction or blocks inflammation could benefit COPD patients. The drug under evaluation in this study, BIO-11006 Inhalation Solution, is a new drug that may inhibit overproduction of mucus and may have important anti-inflammatory properties.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2008
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFebruary 10, 2011
February 1, 2011
2.1 years
March 28, 2008
February 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of BIO-11006 when administered once or twice daily for 21 days to subjects with COPD by assessing adverse events, physical exams, vital signs, pulmonary function, 12 lead electrocardiogram, clinical blood chemistries, hematology, and urinalysis.
Throughout study
Secondary Outcomes (1)
Efficacy of BIO-11006 when administered once or twice daily for 21 days to subjects with COPD by assessing the change from baseline in pulmonary function.
Day 21 of the study
Study Arms (5)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
PLACEBO COMPARATOR5
EXPERIMENTALInterventions
75 mg of BIO-11006 administered once per day for 21 days by nebulizer
Eligibility Criteria
You may qualify if:
- Clinically stable male or female outpatients, 45 years of age or older
- Active COPD with chronic bronchitis indicated by: (1) FEV1 = 40% to 70%, (2) FEV1/FVC ≤70%, (3)Chronic productive cough for 3 months in each of 2 successive years, and (4) Sputum (phlegm) production at least several days a week over the past 4 weeks
- Current or previous smoker with a 20-pack year history
You may not qualify if:
- Treatment with oral prednisone during the 6 weeks before enrollment
- Changed inhaled corticosteroid dose or long acting bronchodilator dose during the 6 weeks before enrollment
- Treatment with oxygen (with the exception of night time oxygen) during the 6 weeks before enrollment
- Current asthma as determined by the investigator
- Change in smoking status during the previous 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Pulmonary Associates
Glendale, Arizona, 85306, United States
Greater Los Angeles Healthcare System
Los Angeles, California, 91343, United States
Bay Pines VA Heatlhcare System
Bay Pines, Florida, 33744, United States
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789, United States
Southeastern Lung Care
Decatur, Georgia, 30033, United States
University of Louisville
Louisville, Kentucky, 40202, United States
VA Sierra Nevada Health Care System
Reno, Nevada, 89502, United States
Duke University Medical Center
Durham, North Carolina, 27704, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Southeastern Research Center, LLC
Winston-Salem, North Carolina, 27103, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Michael E. DeBakey VAMC
Houston, Texas, 77030, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ted C Murphy, Ph.D
BioMarck Pharmaceuticals, Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 1, 2008
Study Start
June 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
February 10, 2011
Record last verified: 2011-02