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

NCT01404000 | Completed Phase 2 DMC

• 1 other identifier: PL0801
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Lung Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in lung function FEV / FVC

  At baseline and after 8 weeks intervention

• HrQoL

  At baseline and after 8 weeks intervention

• Test of thyroid function

  At baseline and after 8 weeks intervention

Study Arms (2)

Iodinated Active Charcoal

ACTIVE COMPARATOR

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

Drug: Iodinated Active Charcoal (IodoCarb)

non-iodinated activated charcoal

PLACEBO COMPARATOR

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

Drug: Iodinated Active Charcoal (IodoCarb)

Interventions

Iodinated Active Charcoal (IodoCarb) DRUG

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

Iodinated Active Charcoal; non-iodinated activated charcoal

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and \>1 year post-menopausal, or surgically sterile female.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PharmaLundensis AB: lead

Study Sites (1)

Dept of Respiratory Medcine & Allergology, Skane University Hospital

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leif Bjermer, MD Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 27, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

SE (1)