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Effectiveness and Safety of BIO-11006 Inhalation Solution to Treat the Overproduction of Mucus and Inflammation in COPD (BREATH-1)
This study is currently recruiting participants.
Verified by BioMarck Pharmaceuticals, Ltd., June 2009
First Received: March 28, 2008   Last Updated: November 19, 2009   History of Changes
Sponsor: BioMarck Pharmaceuticals, Ltd.
Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: BioMarck Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT00648245
  Purpose

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.


Condition Intervention Phase
COPD
Chronic Obstructive Pulmonary Disease
Drug: BIO-11006 Inhalation Solution
Drug: Placebo
Drug: BIO-11006
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by BioMarck Pharmaceuticals, Ltd.:

Primary Outcome Measures:
  • 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. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Day 21 of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 172
Study Start Date: June 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: BIO-11006 Inhalation Solution
75 mg of BIO-11006 administered once per day for 21 days by nebulizer
2: Experimental Drug: BIO-11006 Inhalation Solution
150 mg of BIO-11006 administered once per day for 21 days by nebulizer
3: Experimental Drug: BIO-11006 Inhalation Solution
75 mg of BIO-11006 administered twice per day for 21 days by nebulizer
4: Placebo Comparator Drug: Placebo
Placebo given once daily for 21 days by nebulizer
5: Experimental Drug: BIO-11006
125 mg BIO-11006 given twice per day for 21 days by nebulizer

Detailed Description:

COPD encompasses a number of chronic lung disorders that obstruct the airways and may be accompanied by airway hyperactivity. The most common form of COPD is a combination of chronic bronchitis and emphysema. Many of the signs and symptoms associated with chronic bronchitis are a result of airway mucus hypersecretion induced by chronic inflammation of the airways. Clinically, mucus hypersecretion results in impaired gas exchange and compromised mucociliary clearance, encouraging bacterial colonization and associated exacerbations. A treatment that inhibits mucus hypersecretion or blocks inflammation could benefit COPD patients with chronic bronchitis. The drug under evaluation in this study, BIO 11006, is a new therapeutic agent that may inhibit mucus secretion and may have important anti inflammatory properties. In this study, BIO-11006 will be administered to COPD patients with chronic bronchitis, and the effects lung function will be assessed.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00648245

Contacts
Contact: Ted C Murphy, Ph.D 919-768-1147 tmurphy@biomarck.com

Locations
United States, Arizona
Pulmonary Associates Recruiting
Glendale, Arizona, United States, 85306
Contact: Vince De La Cruz     602-258-4951     vince@pulmonaryassociates.com    
Principal Investigator: Mark Gotfried, MD            
United States, California
Greater Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 91343
Contact: Lisa Stearns     818-895-9388     lisibeme@yahoo.com    
Contact: Samar Kadi     818-895-9388        
Principal Investigator: Michael Littner, M.D.            
United States, Florida
Emerald Coast Research Associates Recruiting
Panama City, Florida, United States, 32405
Contact: Jessica Elkins, CCRC     850-785-6550     jesselkins@bellsouth.net    
Principal Investigator: Timothy G Moriarty, M.D.            
Bay Pines VA Heatlhcare System Recruiting
Bay Pines, Florida, United States, 33744
Contact: Kelly Paradis, RRT     727-398-6661 ext 4432     Kelly.paradis@va.gov    
Principal Investigator: Saifu Daniel, M.D.            
Florida Pulmonary Research Institute, LLC Recruiting
Winter Park, Florida, United States, 32789
Contact: Bob Colern     407-740-8078     colern@fpcresearch.com    
Principal Investigator: Faisal Fakih, MD            
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Rodney J Folz, M.D.     502-852-7422        
Principal Investigator: Rodney J Folz, M.D.            
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Jim Melson     402-559-8592     jmelson@unmc.edu    
Principal Investigator: Steven Rennard, M.D.            
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27704
Contact: Denise Beaver     919-479-0719     Denise.Beaver@duke.edu    
Principal Investigator: Monica Kraft, M.D.            
North Carolina Clinical Research Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Marlys Akin     919-881-0309     makin@nccr.com    
Principal Investigator: Craig LaForce, MD, CPI            
United States, South Carolina
Spartanburg Medical Research Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Sherry Yeisley, CCRC     864-583-9360     syeisley@medresearch.com    
Principal Investigator: Charles Fogarty, MD            
United States, Texas
Diagnostics Research Group Recruiting
San Antonio, Texas, United States, 78229
Contact: Colleen Malady, RN, MSN, CCRC     210-692-7157     cmalady@dxrg.com    
Principal Investigator: John Holcomb, MD, CPI            
Michael E. DeBakey VAMC Recruiting
Houston, Texas, United States, 77030
Contact: Dorothy Williams     713-794-7668     dorothyw@bcm.tmc.edu    
Principal Investigator: Amir Sharafkhaneh, M.D.            
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Melissa Brock     713-873-8772     mbrock@bcm.tmc.edu    
Principal Investigator: Nicola A Hanania, M.D.            
Sponsors and Collaborators
BioMarck Pharmaceuticals, Ltd.
Investigators
Study Director: Ted C Murphy, Ph.D BioMarck Pharmaceuticals, Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: BioMarck Pharmaceuticals, Ltd ( Ted Murphy )
Study ID Numbers: BIM-CL-003
Study First Received: March 28, 2008
Last Updated: November 19, 2009
ClinicalTrials.gov Identifier: NCT00648245     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by BioMarck Pharmaceuticals, Ltd.:
chronic obstructive pulmonary disease
COPD
Chronic bronchitis

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 30, 2009