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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: January 2011

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.

Interventions

  • Drug: Apocynin and placebo nebulization
    • 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.)

Arms, Groups and Cohorts

  • Experimental: COPD patients
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Determination of H2O2
    • Time Frame: 3 months
    • apocynin decreased H2O2 concentrations 60 and 120 minuter after nebulization in comparison to placebo
  • Determination of NO3- concentration in Exhaled Breath Condensate
    • Time Frame: 3 months
    • Apocynin did not influence NO3- concentration in Exhaled Breath Condensate
  • Determination of NO2- concentration in Exhaled Breath Condensate
    • Time Frame: 3 months
    • 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
    • Time Frame: 3 months
    • No influence of apocynin on NO2- Concentration in Serum was observes
  • Blood Pressure
    • Time Frame: 3 months
    • No influence of apocynin on blood pressure was observed
  • Peripheral Blood Differential Count
    • Time Frame: 3 months
    • Apocynin Did Not Cause Any Adverse Effect or influence Peripheral Blood Differential Count
  • Lung Functional Tests
    • Time Frame: 3 months
    • Single breath DLCO was not modified by apocynin nebulization.
  • Single Breath Carbon Monoxide Diffusing Capacity (DLCO)
    • Time Frame: 3 months
    • Apocynin did not influence DLCO

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Lodz
  • Collaborator
    • Ministry of Science and Higher Education, Poland
  • Provider of Information About this Clinical Study
    • Medical University of Lodz, Medical University of Lodz, Lodz, Poland
  • Overall Official(s)
    • Rafal Pawliczak, Professor, Study Chair, Medical University of Lodz

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