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

Primary Purpose

Chronic Obstructive Lung Disease

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Iodinated Active Charcoal (IodoCarb)

About this trial

This is an interventional treatment trial for Chronic Obstructive Lung Disease

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dept of Respiratory Medcine & Allergology, Skane University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Iodinated Active Charcoal

non-iodinated activated charcoal

Arm Description

Iodinated activated charcoal 3 gram daily in the morning for 56 days +- 2 days (=8 weeks)

3g non-iodinated activated charcoal is given daily for 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in lung function FEV / FVC

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

HrQoL

SGRQ CAT

Test of thyroid function

Full Information

NCT ID

NCT01404000

First Posted

July 26, 2011

Last Updated

November 14, 2013

Sponsor

PharmaLundensis AB

1. Study Identification

Unique Protocol Identification Number

NCT01404000

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PharmaLundensis AB

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Lung Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iodinated Active Charcoal

Arm Type

Active Comparator

Arm Description

Iodinated activated charcoal 3 gram daily in the morning for 56 days +- 2 days (=8 weeks)

Arm Title

non-iodinated activated charcoal

Arm Type

Placebo Comparator

Arm Description

3g non-iodinated activated charcoal is given daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Iodinated Active Charcoal (IodoCarb)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Bicycle work load where the endurance time is recorded. The patients are first doing a maximal workload test determining peak oxygen uptake.

Time Frame

At baseline and after 8 weeks intervention

Secondary Outcome Measure Information:

Title

Change in lung function FEV / FVC

Description

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

Time Frame

At baseline and after 8 weeks intervention

Title

HrQoL

Description

SGRQ CAT

Time Frame

At baseline and after 8 weeks intervention

Title

Test of thyroid function

Time Frame

At baseline and after 8 weeks intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leif Bjermer, MD Professor

Organizational Affiliation

Dept of Respiratory Medicine & Allergology, Skane UNiversity Hospital, Lund, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept of Respiratory Medcine & Allergology, Skane University Hospital

City

Lund

ZIP/Postal Code

22185

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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