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

NCT ID: NCT01404000

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Obstructive Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Iodinated Active Charcoal

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

Group Type ACTIVE_COMPARATOR

Iodinated Active Charcoal (IodoCarb)

Intervention Type DRUG

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

non-iodinated activated charcoal

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

Group Type PLACEBO_COMPARATOR

Iodinated Active Charcoal (IodoCarb)

Intervention Type DRUG

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

Interventions

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Iodinated Active Charcoal (IodoCarb)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PharmaLundensis AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leif Bjermer, MD Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Dept of Respiratory Medcine & Allergology, Skane University Hospital

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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PL0801

Identifier Type: -

Identifier Source: org_study_id