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Completed

NCT Number: NCT01404000

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

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

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Key information

Conditions

Chronic Obstructive Lung Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dept of Respiratory Medcine & Allergology, Skane University Hospital

Lund, 22185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iodinated Active Charcoal (IodoCarb)

Drug

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

Primary outcomes

  1. Exercise Endurance time (EET) on constant workload 75% of maximum capacity

    Time frame: 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 outcomes

  1. Change in lung function FEV / FVC

    Time frame: At baseline and after 8 weeks intervention

    Change in FEV and FVC in the morning before and after bronchodilation with SABA.

  2. HrQoL

    Time frame: At baseline and after 8 weeks intervention

    SGRQ CAT

  3. Test of thyroid function

    Time frame: At baseline and after 8 weeks intervention

Sponsors and collaborators

Lead sponsor

PharmaLundensis AB

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 27, 2011
Registry last updated
Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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