Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Iodinated Activated Charcoal

Phase II Study Exploring Efficacy and Safety of Iodinated Activated Charcoal in COPD

The purpose of this study s to determine whether treatment with Iodinated Active Charcoal can improve lung function and physical capacity in patients with chronic obstructive lung disorders. The rational for the study is the observation that COPD patients have an increased tissue load of mercury interfering with the function by NeuroEpithelial Endocrine (NEE) cells in the respiratory tract. Mercury binding to these NEE cells leads to an increased smooth muscle tonus and a reduced response to bronchodilator treatment. Initial observational data have shown an improved lung function and improved functional capacity after treatment motivating a larger placebo controlled POC study

Inclusion Criteria:

• Male and >1 year post-menopausal, or surgically sterile female.
• 45-80 years old.
• Smokers and ex-smokers, at least 15 pack years.
• COPD according to GOLD II. FEV% < 70 Post beta2-agonist FEV1 >50 < 80 % of predicted value
• CO diffusion capacity < 75 %.
• Active symptomatic COPD with a COPD assessment test (CAT) score >10.

Exclusion Criteria:

• Alpha-1 antitrypsin deficiency
• Iodine allergy
• Abnormal thyroid function
• Severely reduced kidney function (Cystatin C > 1.5 mg/L.
• Exacerbation within 4 weeks prior to the study.
• Use of per oral steroids within 4 weeks prior to the study.
• Alcohol/drug abuse.
• Psychiatric disease.
• Severe cardio-vascular or other severe disease, according to the clinical investigator.
• Oxygen treatment.
• Participation in another ongoing clinical trial or participation in drug