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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402297
First Posted: July 26, 2011
Last Update Posted: July 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by:
Medical Universtity of Lodz
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Drug: Apocynin and placebo nebulization Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Hydrogen Peroxide and Nitrite Reduction in Exhaled Breath Condensate of COPD Patients

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome 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 Outcome 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


Enrollment: 13
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402297


Sponsors and Collaborators
Medical Universtity of Lodz
Ministry of Science and Higher Education, Poland
Investigators
Study Chair: Rafal Pawliczak, Professor Medical University of Lodz
  More Information

Responsible Party: Medical University of Lodz, Medical University of Lodz, Lodz, Poland
ClinicalTrials.gov Identifier: NCT01402297     History of Changes
Other Study ID Numbers: Nowak-02
First Submitted: July 18, 2011
First Posted: July 26, 2011
Last Update Posted: July 26, 2011
Last Verified: April 2011

Keywords provided by Medical Universtity of Lodz:
apocynin
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Hydrogen Peroxide
Acetovanillone
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors