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

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Apocynin and placebo nebulization

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.); Other Names: 4-hydroxy-3-methoxyacetophenone,; acetovanillone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Apocynin Did Not Cause Any Adverse Effect or influence blood pressure	3 months
Peripheral Blood Differential Count	Apocynin did not influence Peripheral Blood Differential Count and did not cause any adverse events	3 months
Lung function tests (spirometry)	Apocynin did not cause changes in lung function tests	3 months
Single Breath Carbon Monoxide Diffusing Capacity (DLCO)	Single breath DLCO was not modified by apocynin nebulization.	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Lodz
• Collaborators: Ministry of Science and Higher Education, Poland
• Investigators: Study Chair: Rafal Pawliczak, Professor, Medical University of Lodz

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): April 1, 2011

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 25, 2011
• First Posted (ESTIMATE): July 26, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 26, 2011
• Last Update Submitted That Met QC Criteria: July 25, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: COPD; apocynin
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Protective Agents; Antioxidants; Acetovanillone
• Other Study ID Numbers: Nowak-02