DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 / FVC

HrQoL

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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017