Trial | NCT00648245  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    bio-11006 ...

  • Study Participants

    172
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.
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 Started
Jun 30
2008
Primary Completion
Jul 31
2010
Study Completion
Jul 31
2010
Last Update
Feb 10
2011
Estimate

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

1 Experimental

2 Experimental

3 Experimental

4 Placebo Comparator

5 Experimental

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
No Results Posted