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

Medical University of Lodz13 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Apocynin and placebo nebulizationDRUG

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.)

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Blood Pressure

Apocynin Did Not Cause Any Adverse Effect or influence blood pressure

Time frame: 3 months

Peripheral Blood Differential Count

Apocynin did not influence Peripheral Blood Differential Count and did not cause any adverse events

Time frame: 3 months

Lung function tests (spirometry)

Apocynin did not cause changes in lung function tests

Time frame: 3 months

Single Breath Carbon Monoxide Diffusing Capacity (DLCO)

Single breath DLCO was not modified by apocynin nebulization.

Time frame: 3 months

Secondary Outcomes

Determination of H2O2

apocynin decreased H2O2 concentrations 60 and 120 minuter after nebulization in comparison to placebo

Time frame: 3 months

Determination of NO3- concentration in Exhaled Breath Condensate

Apocynin did not influence NO3- concentration in Exhaled Breath Condensate

Time frame: 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

Time frame: 3 months

Determination of NO2- Concentration in Serum

No influence of apocynin on NO2- Concentration in Serum was observes

Data from ClinicalTrials.gov

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