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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PharmaLundensis AB
ClinicalTrials.gov Identifier:
NCT01404000
First received: July 26, 2011
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Chronic Obstructive Lung Disease
Drug: Iodinated Active Charcoal (IodoCarb)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study Exploring Efficacy and Safety of Iodinated Activated Charcoal in COPD

Resource links provided by NLM:


Further study details as provided by PharmaLundensis AB:

Primary Outcome Measures:
  • Exercise Endurance time (EET) on constant workload 75% of maximum capacity [ Time Frame: At baseline and after 8 weeks intervention ] [ Designated as safety issue: No ]
    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:
  • Change in lung function FEV / FVC [ Time Frame: At baseline and after 8 weeks intervention ] [ Designated as safety issue: No ]
    Change in FEV and FVC in the morning before and after bronchodilation with SABA.

  • HrQoL [ Time Frame: At baseline and after 8 weeks intervention ] [ Designated as safety issue: No ]
    SGRQ CAT

  • Test of thyroid function [ Time Frame: At baseline and after 8 weeks intervention ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404000

Locations
Sweden
Dept of Respiratory Medcine & Allergology, Skane University Hospital
Lund, Sweden, 22185
Sponsors and Collaborators
PharmaLundensis AB
Investigators
Principal Investigator: Leif Bjermer, MD Professor Dept of Respiratory Medicine & Allergology, Skane UNiversity Hospital, Lund, Sweden
  More Information

No publications provided

Responsible Party: PharmaLundensis AB
ClinicalTrials.gov Identifier: NCT01404000     History of Changes
Other Study ID Numbers: PL0801
Study First Received: July 26, 2011
Last Updated: November 14, 2013
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Charcoal
Antidotes
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014