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

NCT01402297 | Completed Phase 1

• 1 other identifier: Nowak-02
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

apocynin; COPD

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Determination of H2O2

  3 months

• Determination of NO3- concentration in Exhaled Breath Condensate

  3 months

• Determination of NO2- concentration in Exhaled Breath Condensate

  3 months

• Determination of NO2- Concentration in Serum

  3 months

• Blood Pressure

  3 months

Study Arms (1)

COPD patients

EXPERIMENTAL

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

Interventions

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.)

Also known as: 4-hydroxy-3-methoxyacetophenone,, acetovanillone

COPD patients

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead
• Ministry of Science and Higher Education, Poland: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

acetovanillone

Condition Hierarchy (Ancestors)

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

Study Officials

• Rafal Pawliczak, Professor

  Medical University of Lodz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 26, 2011
• Study Start: October 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 26, 2011

Record last verified: 2011-04