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

Chronic Obstructive Pulmonary Disease Clinical Trial

— BREATH-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00648245
• Other study ID #: BIM-CL-003
• Secondary ID: 5R44HL073591
• Status: Completed
• Phase: Phase 2
• First received: March 28, 2008
• Last updated: February 9, 2011
• Start date: June 2008
• Est. completion date: July 2010

Study information

• Verified date: February 2011
• Source: BioMarck Pharmaceuticals, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• BIO-11006 Inhalation Solution
75 mg of BIO-11006 administered once per day for 21 days by nebulizer
• BIO-11006 Inhalation Solution
150 mg of BIO-11006 administered once per day for 21 days by nebulizer
• BIO-11006 Inhalation Solution
75 mg of BIO-11006 administered twice per day for 21 days by nebulizer
• Placebo
Placebo given once daily for 21 days by nebulizer
• BIO-11006
125 mg BIO-11006 given twice per day for 21 days by nebulizer

Locations

Country	Name	City	State
United States	Bay Pines VA Heatlhcare System	Bay Pines	Florida
United States	Southeastern Lung Care	Decatur	Georgia
United States	Duke University Medical Center	Durham	North Carolina
United States	Pulmonary Associates	Glendale	Arizona
United States	Baylor College of Medicine	Houston	Texas
United States	Michael E. DeBakey VAMC	Houston	Texas
United States	Greater Los Angeles Healthcare System	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	VA Sierra Nevada Health Care System	Reno	Nevada
United States	Diagnostics Research Group	San Antonio	Texas
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Southeastern Research Center, LLC	Winston Salem	North Carolina
United States	Florida Pulmonary Research Institute, LLC	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
BioMarck Pharmaceuticals, Ltd.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No

External Links

•   Click here for more information about the sponsor of this study