Chronic Obstructive Lung DiseasePhase 2NCT01404000
Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Iodinated Activated Charcoal
A Phase 2 study testing Iodinated Active Charcoal (IodoCarb) in people with Chronic Obstructive Lung Disease, run by PharmaLundensis AB at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Obstructive Lung Disease
- What is being tested?
- Iodinated Active Charcoal (IodoCarb)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2011to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Respiratory Medcine & Allergology, Skane University Hospital
Lund, 22185
About this study
Official title: 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
- Conditions
- Chronic Obstructive Lung Disease
- Being tested
- Iodinated Active Charcoal (IodoCarb)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodinated Active Charcoal (IodoCarb)Drug
3 g will be given as an oral suspension once daily for 56 days
| Study group | Role | What they receive |
|---|---|---|
| Iodinated Active Charcoal | Active comparator | Iodinated activated charcoal 3 gram daily in the morning for 56 days +- 2 days (=8 weeks) Receives: Drug: Iodinated Active Charcoal (IodoCarb) |
| non-iodinated activated charcoal | Placebo comparator | 3g non-iodinated activated charcoal is given daily for 8 weeks Receives: Drug: Iodinated Active Charcoal (IodoCarb) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and after 8 weeks intervention
Secondary outcomes (3)
Change in lung function FEV / FVC
Change in FEV and FVC in the morning before and after bronchodilation with SABA.
Measured: At baseline and after 8 weeks intervention
HrQoL
SGRQ CAT
Measured: At baseline and after 8 weeks intervention
Test of thyroid function
Measured: At baseline and after 8 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaLundensis AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leif Bjermer, MD Professor, Principal investigator, Dept of Respiratory Medicine & Allergology, Skane UNiversity Hospital, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404000
- Sponsor's protocol ID
- PL0801
- Status last verified
- Nov 2013
- First submitted
- 26 Jul 2011
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Exploring Efficacy and Safety of Iodinated Activated Charcoal in COPD
- ClinicalTrials.gov ID
- NCT01404000
- Acronym / sponsor ID
- PL0801
- Conditions
- Chronic Obstructive Lung Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PharmaLundensis ABIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iodinated Active Charcoal | Active comparator | Drug: Iodinated Active Charcoal (IodoCarb)Iodinated activated charcoal 3 gram daily in the morning for 56 days +- 2 days (=8 weeks) |
| non-iodinated activated charcoal | Placebo comparator | Drug: Iodinated Active Charcoal (IodoCarb)3g non-iodinated activated charcoal is given daily for 8 weeks |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 %.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodinated Active Charcoal (IodoCarb)3 g will be given as an oral suspension once daily for 56 days | Drug | Iodinated Active Charcoal, non-iodinated activated charcoal |
Primary outcome
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.
3 secondary outcomes
Change in lung function FEV / FVC
Time frame: At baseline and after 8 weeks intervention
HrQoL
Time frame: At baseline and after 8 weeks intervention
Test of thyroid function
Time frame: At baseline and after 8 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leif Bjermer, MD Professor principal investigator
Dept of Respiratory Medicine & Allergology, Skane UNiversity Hospital, Lund, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iodinated Active Charcoal (IodoCarb) in people with Chronic Obstructive Lung Disease, run by PharmaLundensis AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Endurance time (EET) on constant workload 75% of maximum capacity (time frame: At baseline and after 8 weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013.