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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01404000

Enrollment

Registered

2011-07-27

Start date

2011-11-30

Completion date

2013-05-31

Last updated

2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Lung Disease

Brief summary

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

Interventions

DRUGIodinated Active Charcoal (IodoCarb)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026