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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PharmaLundensis AB
ClinicalTrials.gov Identifier:
NCT01404000
First received: July 26, 2011
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study s to determine whether treatment with Iodinated Active Charcoal can improve lungfunction 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 mtoivating a larger placebo controlled POC study


Condition Intervention Phase
Chronic Obstructive Lung Disease, Moderate Severity
 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:

U.S. FDA Resources

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 recorede. The patients are firts 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 ]

Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Iodinated Active Charcoal, oral suspension
IAC 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 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
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: February 11, 2013
Health Authority: Medical Products Agency, Sweden:

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 May 23, 2013