Chronic Obstructive Pulmonary DiseasePhase 1NCT01402297
Hydrogen Peroxide and Nitrite Reduction in Exhaled Breath Condensate of COPD Patients
A Phase 1 study of Chronic Obstructive Pulmonary Disease, run by Medical University of Lodz.
Trial summary
The aim of the study is to investigate the effect of inhaled apocynin on ROS (reactive oxygen species) and NOS (reactive nitrogen species) synthesis in 13 COPD patients. Effects of nebulized apocynin (0.5 mg/ml, 6 ml) were assessed in exhaled breath condensate (EBC) after 30, 60 and 120 minutes. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Apr 2011
- Phase
- Phase 1
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients suffering from bronchial COPD (II and III stage)
- patients free of any medication few days before research
- patients had not suffered from any infectious diseases including upper respiratory tract infections for at least 3 months prior to the study
Who cannot join
- Patients suffering from GOLD I stage
- patients taking medications few days before the study
- infectious diseases that had occurred 3 months or less before the study
About this study
The aim of the study is to investigate the effect of inhaled apocynin on ROS (reactive oxygen species) and NOS (reactive nitrogen species) synthesis in 13 COPD patients. Effects of nebulized apocynin (0.5 mg/ml, 6 ml) were assessed in exhaled breath condensate (EBC) after 30, 60 and 120 minutes.
Read the detailed description
Apocynin reduced hydrogen peroxide concentration in exhaled breath condensate 60 and 120 minutes after apocynin nebulization comparing to placebo (0.43 μM vs. 0.59 μM and 0.41 μM vs. 0.58 μM respectively, p<0.05). Interestingly, apocynin caused decrease of NO2- concentration 30, 60 and 120 minutes after apocynin inhalation (3.9 μM vs. 4.5 μM, 3.8 μM vs. 4.5 μM and 3.7 μM vs. 4,4 μM respectively, p<0.05) comparing to placebo, but did not cause any significant changes in concentration of NO3- in any timepoint (p>0.05). No influence of apocynin on safety parameters, and no adverse effects has been observed.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Apocynin and placebo nebulization
- Keywords
- apocynin, COPD
- 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.
Apocynin and placebo nebulizationDrug
Also called 4-hydroxy-3-methoxyacetophenone,, acetovanillone
6 ml of apocynin of total dose 3 mg (0.5 mg/ml dissolved in sterile 0.9% NaCl as the study drug) and 0,9% NaCl as placebo, has been nebulized for 15-20 min through the mouthpiece with using of a nose clip. A nebulizer Pulmo Aide AP-50 (DeVilbiss; Richmond, VA) was used (mass median aerosol diameter 3.1 mm, output 0.3 ml/min.)
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Experimental | Thirteen nonsmoking patients, suffering from GOLD II and GOLD III stage participated in the study (mean age 57 years (range 42-79), 9 men, 4 women). COPD was diagnosed based on GOLD 2009 criteria. All the participants were diagnosed at Department of Clinical Physiology, Medical university of Lodz. Receives: Drug: Apocynin and placebo nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Apocynin Did Not Cause Any Adverse Effect or influence blood pressure
Measured: 3 months
Peripheral Blood Differential Count
Apocynin did not influence Peripheral Blood Differential Count and did not cause any adverse events
Measured: 3 months
Lung function tests (spirometry)
Apocynin did not cause changes in lung function tests
Measured: 3 months
Single Breath Carbon Monoxide Diffusing Capacity (DLCO)
Single breath DLCO was not modified by apocynin nebulization.
Measured: 3 months
Secondary outcomes (8)
Determination of H2O2
apocynin decreased H2O2 concentrations 60 and 120 minuter after nebulization in comparison to placebo
Measured: 3 months
Determination of NO3- concentration in Exhaled Breath Condensate
Apocynin did not influence NO3- concentration in Exhaled Breath Condensate
Measured: 3 months
Determination of NO2- concentration in Exhaled Breath Condensate
Apocynin decreased NO2- concentration in Exhaled Breath Condensate 30, 60 and 120 minuter after nebulization in comparison to placebo
Measured: 3 months
Determination of NO2- Concentration in Serum
No influence of apocynin on NO2- Concentration in Serum was observes
Measured: 3 months
Blood Pressure
No influence of apocynin on blood pressure was observed
Measured: 3 months
Peripheral Blood Differential Count
Apocynin Did Not Cause Any Adverse Effect or influence Peripheral Blood Differential Count
Measured: 3 months
Lung Functional Tests
Single breath DLCO was not modified by apocynin nebulization.
Measured: 3 months
Single Breath Carbon Monoxide Diffusing Capacity (DLCO)
Apocynin did not influence DLCO
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Higher Education, Poland
- Investigators
- Rafal Pawliczak, Professor, Study chair, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402297
- Sponsor's protocol ID
- Nowak-02
- Status last verified
- Apr 2011
- First submitted
- 18 Jul 2011
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrogen Peroxide and Nitrite Reduction in Exhaled Breath Condensate of COPD Patients
- ClinicalTrials.gov ID
- NCT01402297
- Acronym / sponsor ID
- Nowak-02
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- apocynin, COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Collaborators
- Ministry of Science and Higher Education, Poland
- Study start
- Oct 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 26 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 aim of the study is to investigate the effect of inhaled apocynin on ROS (reactive oxygen species) and NOS (reactive nitrogen species) synthesis in 13 COPD patients. Effects of nebulized apocynin (0.5 mg/ml, 6 ml) were assessed in exhaled breath condensate (EBC) after 30, 60 and 120 minutes.
Detailed description
Apocynin reduced hydrogen peroxide concentration in exhaled breath condensate 60 and 120 minutes after apocynin nebulization comparing to placebo (0.43 μM vs. 0.59 μM and 0.41 μM vs. 0.58 μM respectively, p<0.05). Interestingly, apocynin caused decrease of NO2- concentration 30, 60 and 120 minutes after apocynin inhalation (3.9 μM vs. 4.5 μM, 3.8 μM vs. 4.5 μM and 3.7 μM vs. 4,4 μM respectively, p<0.05) comparing to placebo, but did not cause any significant changes in concentration of NO3- in any timepoint (p>0.05). No influence of apocynin on safety parameters, and no adverse effects has been observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | Experimental | Drug: Apocynin and placebo nebulizationThirteen nonsmoking patients, suffering from GOLD II and GOLD III stage participated in the study (mean age 57 years (range 42-79), 9 men, 4 women). COPD was diagnosed based on GOLD 2009 criteria. All the participants were diagnosed at Department of Clinical Physiology, Medical university of Lodz. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients suffering from bronchial COPD (II and III stage)
- patients free of any medication few days before research
- patients had not suffered from any infectious diseases including upper respiratory tract infections for at least 3 months prior to the study
Key exclusion criteria (3 listed)
- Patients suffering from GOLD I stage
- patients taking medications few days before the study
- infectious diseases that had occurred 3 months or less before 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 |
|---|---|---|
| Apocynin and placebo nebulizationAlso: 4-hydroxy-3-methoxyacetophenone,, acetovanillone6 ml of apocynin of total dose 3 mg (0.5 mg/ml dissolved in sterile 0.9% NaCl as the study drug) and 0,9% NaCl as placebo, has been nebulized for 15-20 min through the mouthpiece with using of a nose clip. A nebulizer Pulmo Aide AP-50 (DeVilbiss; Richmond, VA) was used (mass median aerosol diameter 3.1 mm, output 0.3 ml/min.) | Drug | COPD patients |
Primary outcome
Blood Pressure
Time frame: 3 months
Apocynin Did Not Cause Any Adverse Effect or influence blood pressure
Peripheral Blood Differential Count
Time frame: 3 months
Apocynin did not influence Peripheral Blood Differential Count and did not cause any adverse events
Lung function tests (spirometry)
Time frame: 3 months
Apocynin did not cause changes in lung function tests
Single Breath Carbon Monoxide Diffusing Capacity (DLCO)
Time frame: 3 months
Single breath DLCO was not modified by apocynin nebulization.
8 secondary outcomes
Determination of H2O2
Time frame: 3 months
Determination of NO3- concentration in Exhaled Breath Condensate
Time frame: 3 months
Determination of NO2- concentration in Exhaled Breath Condensate
Time frame: 3 months
Determination of NO2- Concentration in Serum
Time frame: 3 months
Blood Pressure
Time frame: 3 months
Peripheral Blood Differential Count
Time frame: 3 months
Lung Functional Tests
Time frame: 3 months
Single Breath Carbon Monoxide Diffusing Capacity (DLCO)
Time frame: 3 months
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 26 Jul 2011.
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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.
Rafal Pawliczak, Professor study chair
Medical University of Lodz
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Chronic Obstructive Pulmonary Disease, run by Medical University of Lodz.
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 3 inclusion and 3 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 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Blood Pressure (time frame: 3 months). The study lists 4 primary outcomes in all. 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 26 Jul 2011.