- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01404000
Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Iodinated Activated Charcoal
November 14, 2013 updated by: PharmaLundensis AB
Phase II Study Exploring Efficacy and Safety of Iodinated Activated Charcoal in COPD
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Lund, Sweden, 22185
- Dept of Respiratory Medcine & Allergology, Skane University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Iodinated Active Charcoal
Iodinated activated charcoal 3 gram daily in the morning for 56 days +- 2 days (=8 weeks)
|
3 g will be given as an oral suspension once daily for 56 days
|
PLACEBO_COMPARATOR: non-iodinated activated charcoal
3g non-iodinated activated charcoal is given daily for 8 weeks
|
3 g will be given as an oral suspension once daily for 56 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise Endurance time (EET) on constant workload 75% of maximum capacity
Time Frame: 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.
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At baseline and after 8 weeks intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in lung function FEV / FVC
Time Frame: At baseline and after 8 weeks intervention
|
Change in FEV and FVC in the morning before and after bronchodilation with SABA.
|
At baseline and after 8 weeks intervention
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HrQoL
Time Frame: At baseline and after 8 weeks intervention
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SGRQ CAT
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At baseline and after 8 weeks intervention
|
Test of thyroid function
Time Frame: At baseline and after 8 weeks intervention
|
At baseline and after 8 weeks intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leif Bjermer, MD Professor, Dept of Respiratory Medicine & Allergology, Skane UNiversity Hospital, Lund, Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (ACTUAL)
May 1, 2013
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
July 26, 2011
First Submitted That Met QC Criteria
July 26, 2011
First Posted (ESTIMATE)
July 27, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
November 15, 2013
Last Update Submitted That Met QC Criteria
November 14, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PL0801
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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