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Completed

NCT Number: NCT01402297

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apocynin and placebo nebulization

Drug

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

Primary outcomes

  1. Blood Pressure

    Time frame: 3 months

    Apocynin Did Not Cause Any Adverse Effect or influence blood pressure

  2. Peripheral Blood Differential Count

    Time frame: 3 months

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

  3. Lung function tests (spirometry)

    Time frame: 3 months

    Apocynin did not cause changes in lung function tests

  4. Single Breath Carbon Monoxide Diffusing Capacity (DLCO)

    Time frame: 3 months

    Single breath DLCO was not modified by apocynin nebulization.

Secondary outcomes

  1. Determination of H2O2

    Time frame: 3 months

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

  2. Determination of NO3- concentration in Exhaled Breath Condensate

    Time frame: 3 months

    Apocynin did not influence NO3- concentration in Exhaled Breath Condensate

  3. 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

  4. Determination of NO2- Concentration in Serum

    Time frame: 3 months

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

  5. Blood Pressure

    Time frame: 3 months

    No influence of apocynin on blood pressure was observed

  6. Peripheral Blood Differential Count

    Time frame: 3 months

    Apocynin Did Not Cause Any Adverse Effect or influence Peripheral Blood Differential Count

  7. Lung Functional Tests

    Time frame: 3 months

    Single breath DLCO was not modified by apocynin nebulization.

  8. Single Breath Carbon Monoxide Diffusing Capacity (DLCO)

    Time frame: 3 months

    Apocynin did not influence DLCO

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Collaborators

  • Ministry of Science and Higher Education, Poland

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 26, 2011
Registry last updated
Jul 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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