Hydrogen Peroxide and Nitrite Reduction in Exhaled Breath Condensate of COPD Patients
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT01402297
- Lead Sponsor
- Medical University of Lodz
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description COPD patients Apocynin and placebo nebulization 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.
- Primary Outcome Measures
Name Time Method Blood Pressure 3 months Apocynin Did Not Cause Any Adverse Effect or influence blood pressure
Peripheral Blood Differential Count 3 months Apocynin did not influence Peripheral Blood Differential Count and did not cause any adverse events
Lung function tests (spirometry) 3 months Apocynin did not cause changes in lung function tests
Single Breath Carbon Monoxide Diffusing Capacity (DLCO) 3 months Single breath DLCO was not modified by apocynin nebulization.
- Secondary Outcome Measures
Name Time Method Determination of H2O2 3 months apocynin decreased H2O2 concentrations 60 and 120 minuter after nebulization in comparison to placebo
Determination of NO3- concentration in Exhaled Breath Condensate 3 months Apocynin did not influence NO3- concentration in Exhaled Breath Condensate
Determination of NO2- concentration in Exhaled Breath Condensate 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 3 months No influence of apocynin on NO2- Concentration in Serum was observes
Blood Pressure 3 months No influence of apocynin on blood pressure was observed
Peripheral Blood Differential Count 3 months Apocynin Did Not Cause Any Adverse Effect or influence Peripheral Blood Differential Count
Lung Functional Tests 3 months Single breath DLCO was not modified by apocynin nebulization.
Single Breath Carbon Monoxide Diffusing Capacity (DLCO) 3 months Apocynin did not influence DLCO