search
Back to results

Hydrogen Peroxide and Nitrite Reduction in Exhaled Breath Condensate of COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Apocynin and placebo nebulization
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring apocynin, COPD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    COPD patients

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Blood Pressure
    Apocynin Did Not Cause Any Adverse Effect or influence blood pressure
    Peripheral Blood Differential Count
    Apocynin did not influence Peripheral Blood Differential Count and did not cause any adverse events
    Lung function tests (spirometry)
    Apocynin did not cause changes in lung function tests
    Single Breath Carbon Monoxide Diffusing Capacity (DLCO)
    Single breath DLCO was not modified by apocynin nebulization.

    Secondary Outcome Measures

    Determination of H2O2
    apocynin decreased H2O2 concentrations 60 and 120 minuter after nebulization in comparison to placebo
    Determination of NO3- concentration in Exhaled Breath Condensate
    Apocynin did not influence NO3- concentration in Exhaled Breath Condensate
    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
    Determination of NO2- Concentration in Serum
    No influence of apocynin on NO2- Concentration in Serum was observes
    Blood Pressure
    No influence of apocynin on blood pressure was observed
    Peripheral Blood Differential Count
    Apocynin Did Not Cause Any Adverse Effect or influence Peripheral Blood Differential Count
    Lung Functional Tests
    Single breath DLCO was not modified by apocynin nebulization.
    Single Breath Carbon Monoxide Diffusing Capacity (DLCO)
    Apocynin did not influence DLCO

    Full Information

    First Posted
    July 18, 2011
    Last Updated
    July 25, 2011
    Sponsor
    Medical University of Lodz
    Collaborators
    Ministry of Science and Higher Education, Poland
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01402297
    Brief Title
    Hydrogen Peroxide and Nitrite Reduction in Exhaled Breath Condensate of COPD Patients
    Official Title
    Hydrogen Peroxide and Nitrite Reduction in Exhaled Breath Condensate of COPD Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Medical University of Lodz
    Collaborators
    Ministry of Science and Higher Education, Poland

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    apocynin, COPD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    COPD patients
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Apocynin and placebo nebulization
    Other Intervention Name(s)
    4-hydroxy-3-methoxyacetophenone,, acetovanillone
    Intervention Description
    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.)
    Primary Outcome Measure Information:
    Title
    Blood Pressure
    Description
    Apocynin Did Not Cause Any Adverse Effect or influence blood pressure
    Time Frame
    3 months
    Title
    Peripheral Blood Differential Count
    Description
    Apocynin did not influence Peripheral Blood Differential Count and did not cause any adverse events
    Time Frame
    3 months
    Title
    Lung function tests (spirometry)
    Description
    Apocynin did not cause changes in lung function tests
    Time Frame
    3 months
    Title
    Single Breath Carbon Monoxide Diffusing Capacity (DLCO)
    Description
    Single breath DLCO was not modified by apocynin nebulization.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Determination of H2O2
    Description
    apocynin decreased H2O2 concentrations 60 and 120 minuter after nebulization in comparison to placebo
    Time Frame
    3 months
    Title
    Determination of NO3- concentration in Exhaled Breath Condensate
    Description
    Apocynin did not influence NO3- concentration in Exhaled Breath Condensate
    Time Frame
    3 months
    Title
    Determination of NO2- concentration in Exhaled Breath Condensate
    Description
    Apocynin decreased NO2- concentration in Exhaled Breath Condensate 30, 60 and 120 minuter after nebulization in comparison to placebo
    Time Frame
    3 months
    Title
    Determination of NO2- Concentration in Serum
    Description
    No influence of apocynin on NO2- Concentration in Serum was observes
    Time Frame
    3 months
    Title
    Blood Pressure
    Description
    No influence of apocynin on blood pressure was observed
    Time Frame
    3 months
    Title
    Peripheral Blood Differential Count
    Description
    Apocynin Did Not Cause Any Adverse Effect or influence Peripheral Blood Differential Count
    Time Frame
    3 months
    Title
    Lung Functional Tests
    Description
    Single breath DLCO was not modified by apocynin nebulization.
    Time Frame
    3 months
    Title
    Single Breath Carbon Monoxide Diffusing Capacity (DLCO)
    Description
    Apocynin did not influence DLCO
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rafal Pawliczak, Professor
    Organizational Affiliation
    Medical University of Lodz
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Hydrogen Peroxide and Nitrite Reduction in Exhaled Breath Condensate of COPD Patients

    We'll reach out to this number within 24 hrs