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

Phase 2

Completed

• Conditions: Chronic Obstructive Lung Disease
• Interventions: Drug: Iodinated Active Charcoal (IodoCarb)

• Registration Number: NCT01404000
• Lead Sponsor: PharmaLundensis AB

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Study Start: 2011-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodinated Active Charcoal	Iodinated Active Charcoal (IodoCarb)	Iodinated activated charcoal 3 gram daily in the morning for 56 days +- 2 days (=8 weeks)
non-iodinated activated charcoal	Iodinated Active Charcoal (IodoCarb)	3g non-iodinated activated charcoal is given daily for 8 weeks

Primary Outcome Measures

Name	Time	Method
Exercise Endurance time (EET) on constant workload 75% of maximum capacity	At baseline and after 8 weeks intervention	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

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

Trial Locations

Locations (1)

Dept of Respiratory Medcine & Allergology, Skane University Hospital; 🇸🇪 Lund, Sweden