Effectiveness and Safety of BIO-11006 Inhalation Solution to Treat the Overproduction of Mucus and Inflammation in COPD (BREATH-1)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
BioMarck Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier:
NCT00648245
First received: March 28, 2008
Last updated: February 9, 2011
Last verified: February 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: BIO-11006 Inhalation Solution
75 mg of BIO-11006 administered once per day for 21 days by nebulizer
Experimental: 2 Drug: BIO-11006 Inhalation Solution
150 mg of BIO-11006 administered once per day for 21 days by nebulizer
Experimental: 3 Drug: BIO-11006 Inhalation Solution
75 mg of BIO-11006 administered twice per day for 21 days by nebulizer
Placebo Comparator: 4 Drug: Placebo
Placebo given once daily for 21 days by nebulizer
Experimental: 5 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648245

Locations
United States, Arizona
Pulmonary Associates
Glendale, Arizona, United States, 85306
United States, California
Greater Los Angeles Healthcare System
Los Angeles, California, United States, 91343
United States, Florida
Bay Pines VA Heatlhcare System
Bay Pines, Florida, United States, 33744
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, United States, 32789
United States, Georgia
Southeastern Lung Care
Decatur, Georgia, United States, 30033
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Nevada
VA Sierra Nevada Health Care System
Reno, Nevada, United States, 89502
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27704
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
Southeastern Research Center, LLC
Winston Salem, North Carolina, United States, 27103
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Michael E. DeBakey VAMC
Houston, Texas, United States, 77030
Diagnostics Research Group
San Antonio, Texas, United States, 78229
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: Ted Murphy, BioMarck Pharmaceuticals, Ltd
ClinicalTrials.gov Identifier: NCT00648245     History of Changes
Other Study ID Numbers: BIM-CL-003, 5R44HL073591
Study First Received: March 28, 2008
Last Updated: February 9, 2011
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014