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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; COPD
• Intervention / Treatment: Drug: BIO-11006 Inhalation Solution; Drug: BIO-11006 Inhalation Solution; Drug: BIO-11006 Inhalation Solution; Drug: Placebo; Drug: BIO-11006

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 Type: Interventional
• Enrollment (Anticipated): 172
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Pulmonary Associates
  • California
    • Los Angeles, California, United States, 91343
      • Greater Los Angeles Healthcare System
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines VA Heatlhcare System
    • Winter Park, Florida, United States, 32789
      • Florida Pulmonary Research Institute, LLC
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Southeastern Lung Care
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Nevada
    • Reno, Nevada, United States, 89502
      • VA Sierra Nevada Health Care System
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
    • Winston Salem, North Carolina, United States, 27103
      • Southeastern Research Center, LLC
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VAMC
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: BIO-11006 Inhalation Solution; 75 mg of BIO-11006 administered once per day for 21 days by nebulizer; Drug: BIO-11006 Inhalation Solution; 150 mg of BIO-11006 administered once per day for 21 days by nebulizer; Drug: BIO-11006 Inhalation Solution; 75 mg of BIO-11006 administered twice per day for 21 days by nebulizer
Experimental: 2	Drug: BIO-11006 Inhalation Solution; 75 mg of BIO-11006 administered once per day for 21 days by nebulizer; Drug: BIO-11006 Inhalation Solution; 150 mg of BIO-11006 administered once per day for 21 days by nebulizer; Drug: BIO-11006 Inhalation Solution; 75 mg of BIO-11006 administered twice per day for 21 days by nebulizer
Experimental: 3	Drug: BIO-11006 Inhalation Solution; 75 mg of BIO-11006 administered once per day for 21 days by nebulizer; Drug: BIO-11006 Inhalation Solution; 150 mg of BIO-11006 administered once per day for 21 days by nebulizer; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: BioMarck Pharmaceuticals, Ltd.
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Study Director: Ted C Murphy, Ph.D, BioMarck Pharmaceuticals, Ltd.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (Estimate): April 1, 2008

Study Record Updates

• Last Update Posted (Estimate): February 10, 2011
• Last Update Submitted That Met QC Criteria: February 9, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: COPD; chronic obstructive pulmonary disease; Chronic bronchitis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pharmaceutical Solutions
• Other Study ID Numbers: BIM-CL-003; 5R44HL073591 (U.S. NIH Grant/Contract)