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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
BioMarck Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier:
NCT00648245
First received: March 28, 2008
Last updated: February 9, 2011
Last verified: February 2011

March 28, 2008
February 9, 2011
June 2008
July 2010   (final data collection date for primary outcome 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. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Safety of BIO-11006 when administered once daily for 21 days to subjects with COPD by assessing adverse events, physical examinations and vital signs, pulmonary function, 12 lead electrocardiogram, clinical blood chemistries, hematology, and urinalysis. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00648245 on ClinicalTrials.gov Archive Site
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. [ Time Frame: Day 21 of the study ] [ Designated as safety issue: No ]
Efficacy of BIO-11006 when administered once daily for 21 days to subjects with COPD by assessing the change from baseline in pulmonary function. [ Time Frame: Day 21 of the study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • COPD
  • Chronic Obstructive Pulmonary Disease
  • 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
  • Experimental: 1
    Intervention: Drug: BIO-11006 Inhalation Solution
  • Experimental: 2
    Intervention: Drug: BIO-11006 Inhalation Solution
  • Experimental: 3
    Intervention: Drug: BIO-11006 Inhalation Solution
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
  • Experimental: 5
    Intervention: Drug: BIO-11006
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00648245
BIM-CL-003, 5R44HL073591
Yes
Ted Murphy, BioMarck Pharmaceuticals, Ltd
BioMarck Pharmaceuticals, Ltd.
National Heart, Lung, and Blood Institute (NHLBI)
Study Director: Ted C Murphy, Ph.D BioMarck Pharmaceuticals, Ltd.
BioMarck Pharmaceuticals, Ltd.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP