Trial | NCT01404000  Report issue

Title

Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Iodinated Activated Charcoal
Phase II Study Exploring Efficacy and Safety of Iodinated Activated Charcoal in COPD

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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
Study Started
Nov 30
2011
Primary Completion
May 31
2013
Study Completion
May 31
2013
Last Update
Nov 15
2013
Estimate

Drug Iodinated Active Charcoal (IodoCarb)

3 g will be given as an oral suspension once daily for 56 days

Iodinated Active Charcoal Active Comparator

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

non-iodinated activated charcoal Placebo Comparator

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

Criteria 

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
No Results Posted