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

Biomarck Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease; COPD

Treatments: Drug: BIO-11006; Drug: Placebo; Drug: BIO-11006 Inhalation Solution

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00648245

BIM-CL-003

5R44HL073591 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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172 participants in 5 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: BIO-11006 Inhalation Solution

Drug: BIO-11006 Inhalation Solution

Drug: BIO-11006 Inhalation Solution

2

Experimental group

Treatment:

Drug: BIO-11006 Inhalation Solution

Drug: BIO-11006 Inhalation Solution

Drug: BIO-11006 Inhalation Solution

3

Experimental group

Treatment:

Drug: BIO-11006 Inhalation Solution

Drug: BIO-11006 Inhalation Solution

Drug: BIO-11006 Inhalation Solution

4

Placebo Comparator group

Treatment:

Drug: Placebo

5

Experimental group

Treatment:

Drug: BIO-11006