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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Lung Disease
• Intervention / Treatment: Drug: Iodinated Active Charcoal (IodoCarb)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22185
    • Dept of Respiratory Medcine & Allergology, Skane University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PharmaLundensis AB
• Investigators: Principal Investigator: Leif Bjermer, MD Professor, Dept of Respiratory Medicine & Allergology, Skane UNiversity Hospital, Lund, Sweden

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: July 26, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (ESTIMATE): July 27, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 15, 2013
• Last Update Submitted That Met QC Criteria: November 14, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Protective Agents; Antidotes; Charcoal
• Other Study ID Numbers: PL0801