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

PharmaLundensis

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Lung Disease

Treatments: Drug: Iodinated Active Charcoal (IodoCarb)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01404000

PL0801

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Iodinated Active Charcoal

Active Comparator group

Description:

Iodinated activated charcoal 3 gram daily in the morning for 56 days +- 2 days (=8 weeks)

Treatment:

Drug: Iodinated Active Charcoal (IodoCarb)

non-iodinated activated charcoal

Placebo Comparator group

Description:

3g non-iodinated activated charcoal is given daily for 8 weeks

Treatment:

Drug: Iodinated Active Charcoal (IodoCarb)