A Phase 2 interventional study of BIO-11006 Inhalation Solution and BIO-11006 Inhalation Solution in COPD and Chronic Obstructive Pulmonary Disease, sponsored by BioMarck Pharmaceuticals, Ltd.. Completed at 14 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2011-02-10.
Sponsored by BioMarck Pharmaceuticals, Ltd. · Phase 2, Interventional, and Treatment
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 172 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →BioMarck Pharmaceuticals, Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BIO-11006 Inhalation Solution
Drug: BIO-11006 Inhalation Solution
Drug: BIO-11006 Inhalation Solution
Drug: Placebo
Drug: BIO-11006
75 mg of BIO-11006 administered once per day for 21 days by nebulizer
150 mg of BIO-11006 administered once per day for 21 days by nebulizer
75 mg of BIO-11006 administered twice per day for 21 days by nebulizer
Placebo given once daily for 21 days by nebulizer
125 mg BIO-11006 given twice per day for 21 days by nebulizer
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
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
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: BIO-11006
Pulmonary Disease, Chronic Obstructive →
BioMarck Pharmaceuticals, Ltd.