NCT00648245

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: BioMarck Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
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
DRUG	Placebo	Placebo given once daily for 21 days by nebulizer
DRUG	BIO-11006	125 mg BIO-11006 given twice per day for 21 days by nebulizer

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-04-01
• Last updated: 2011-02-10

Locations

14 sites across 1 country: United States