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

Sponsor

BioMarck Pharmaceuticals, Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00648245

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

172

Enrollment

Locations

Arms

Duration (Months)

12.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD Chronic Obstructive Pulmonary Disease	Drug: BIO-11006 Inhalation Solution Drug: BIO-11006 Inhalation Solution Drug: BIO-11006 Inhalation Solution Drug: Placebo Drug: BIO-11006	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

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. [Throughout study]

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. [Day 21 of the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Pulmonary Associates	Glendale	Arizona	United States	85306
2	Greater Los Angeles Healthcare System	Los Angeles	California	United States	91343
3	Bay Pines VA Heatlhcare System	Bay Pines	Florida	United States	33744
4	Florida Pulmonary Research Institute, LLC	Winter Park	Florida	United States	32789
5	Southeastern Lung Care	Decatur	Georgia	United States	30033
6	University of Louisville	Louisville	Kentucky	United States	40202
7	VA Sierra Nevada Health Care System	Reno	Nevada	United States	89502
8	Duke University Medical Center	Durham	North Carolina	United States	27704
9	North Carolina Clinical Research	Raleigh	North Carolina	United States	27607
10	Southeastern Research Center, LLC	Winston Salem	North Carolina	United States	27103
11	Spartanburg Medical Research	Spartanburg	South Carolina	United States	29303
12	Baylor College of Medicine	Houston	Texas	United States	77030
13	Michael E. DeBakey VAMC	Houston	Texas	United States	77030
14	Diagnostics Research Group	San Antonio	Texas	United States	78229