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

Chronic Obstructive Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404000
• Other study ID #: PL0801
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2011
• Last updated: November 14, 2013
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: November 2013
• Source: PharmaLundensis AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Iodinated Active Charcoal (IodoCarb)
3 g will be given as an oral suspension once daily for 56 days

Locations

Country	Name	City	State
Sweden	Dept of Respiratory Medcine & Allergology, Skane University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
PharmaLundensis AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	HrQoL	SGRQ CAT	At baseline and after 8 weeks intervention
Secondary	Test of thyroid function		At baseline and after 8 weeks intervention