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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01402297
First received: July 18, 2011
Last updated: July 25, 2011
Last verified: April 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    Apocynin Did Not Cause Any Adverse Effect or influence blood pressure

  • Peripheral Blood Differential Count [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Apocynin did not influence Peripheral Blood Differential Count and did not cause any adverse events

  • Lung function tests (spirometry) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Apocynin did not cause changes in lung function tests

  • Single Breath Carbon Monoxide Diffusing Capacity (DLCO) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Single breath DLCO was not modified by apocynin nebulization.


Secondary Outcome Measures:
  • Determination of H2O2 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Apocynin did not influence NO3- concentration in Exhaled Breath Condensate

  • Determination of NO2- concentration in Exhaled Breath Condensate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    No influence of apocynin on NO2- Concentration in Serum was observes

  • Blood Pressure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    No influence of apocynin on blood pressure was observed

  • Peripheral Blood Differential Count [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Apocynin Did Not Cause Any Adverse Effect or influence Peripheral Blood Differential Count

  • Lung Functional Tests [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Single breath DLCO was not modified by apocynin nebulization.

  • Single Breath Carbon Monoxide Diffusing Capacity (DLCO) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 18, 2011
Last Updated: July 25, 2011
Health Authority: Poland: Ministry of Science and Higher Education

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
Acetovanillone
Hydrogen Peroxide
Analgesics
Analgesics, Non-Narcotic
Anti-Infective Agents
Anti-Infective Agents, Local
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antioxidants
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014