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Trial record 1 of 2 for:    iodinated activated charcoal
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Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Iodinated Activated Charcoal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01404000
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : November 15, 2013
Information provided by (Responsible Party):
PharmaLundensis AB

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Lung Disease Drug: Iodinated Active Charcoal (IodoCarb) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study Exploring Efficacy and Safety of Iodinated Activated Charcoal in COPD
Study Start Date : November 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Active Comparator: Iodinated Active Charcoal
Iodinated activated charcoal 3 gram daily in the morning for 56 days +- 2 days (=8 weeks)
Drug: Iodinated Active Charcoal (IodoCarb)
3 g will be given as an oral suspension once daily for 56 days

Placebo Comparator: non-iodinated activated charcoal
3g non-iodinated activated charcoal is given daily for 8 weeks
Drug: Iodinated Active Charcoal (IodoCarb)
3 g will be given as an oral suspension once daily for 56 days

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

  3. Test of thyroid function [ Time Frame: At baseline and after 8 weeks intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01404000

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Dept of Respiratory Medcine & Allergology, Skane University Hospital
Lund, Sweden, 22185
Sponsors and Collaborators
PharmaLundensis AB
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Principal Investigator: Leif Bjermer, MD Professor Dept of Respiratory Medicine & Allergology, Skane UNiversity Hospital, Lund, Sweden
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Responsible Party: PharmaLundensis AB Identifier: NCT01404000    
Other Study ID Numbers: PL0801
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Protective Agents
Physiological Effects of Drugs