Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Iodinated Activated Charcoal
Information source: PharmaLundensis AB
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Lung Disease
Intervention: Iodinated Active Charcoal (IodoCarb) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: PharmaLundensis AB Official(s) and/or principal investigator(s): Leif Bjermer, MD Professor, Principal Investigator, Affiliation: Dept of Respiratory Medicine & Allergology, Skane UNiversity Hospital, Lund, Sweden
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
Clinical Details
Official title: Phase II Study Exploring Efficacy and Safety of Iodinated Activated Charcoal in COPD
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Exercise Endurance time (EET) on constant workload 75% of maximum capacity
Secondary outcome: Change in lung function FEV / FVCHrQoL Test of thyroid function
Eligibility
Minimum age: 45 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Dept of Respiratory Medcine & Allergology, Skane University Hospital, Lund 22185, Sweden
Additional Information
Starting date: November 2011
Last updated: November 14, 2013
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