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

Study Overview
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Brief Summary
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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

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

Conditions
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Chronic Obstructive Lung Disease

Intervention / Treatment
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* Drug: Iodinated Active Charcoal (IodoCarb)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iodinated Active Charcoal<br>Iodinated activated charcoal 3 gram daily in the morning for 56 days +- 2 days (=8 weeks) | Drug: Iodinated Active Charcoal (IodoCarb)<br>* 3 g will be given as an oral suspension once daily for 56 days<br>|
| Placebo Comparator: non-iodinated activated charcoal<br>3g non-iodinated activated charcoal is given daily for 8 weeks | Drug: Iodinated Active Charcoal (IodoCarb)<br>* 3 g will be given as an oral suspension once daily for 56 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Endurance time (EET) on constant workload 75% of maximum capacity | Bicycle work load where the endurance time is recorded. The patients are first doing a maximal workload test determining peak oxygen uptake. | At baseline and after 8 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function FEV / FVC | Change in FEV and FVC in the morning before and after bronchodilation with SABA. | At baseline and after 8 weeks intervention | 
| HrQoL | SGRQ CAT | At baseline and after 8 weeks intervention | 
| Test of thyroid function |  | At baseline and after 8 weeks intervention |