Clinical trial NCT00648245: Effectiveness and Safety of BIO-11006 Inhalation Solution to Treat the Overproduction of Mucus and Inflammation in COPD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
COPD
Chronic bronchitis
Lead sponsor: BioMarck Pharmaceuticals, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-04-01
Enrollment: 172
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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.
timeFrame: Throughout study
Secondary outcomes:
measure: 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.
timeFrame: Day 21 of the study
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pulmonary Associates
state: Arizona
city: Los Angeles
country: United States
facility: Greater Los Angeles Healthcare System
state: California
city: Bay Pines
country: United States
facility: Bay Pines VA Heatlhcare System
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute, LLC
state: Florida
city: Decatur
country: United States
facility: Southeastern Lung Care
state: Georgia
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Reno
country: United States
facility: VA Sierra Nevada Health Care System
state: Nevada
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Winston Salem
country: United States
facility: Southeastern Research Center, LLC
state: North Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VAMC
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
Study officials:
affiliation: BioMarck Pharmaceuticals, Ltd.
name: Ted C Murphy, Ph.D
role: STUDY_DIRECTOR
References: