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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402297
• Other study ID #: Nowak-02
• Status: Completed
• Phase: Phase 1
• First received: July 18, 2011
• Last updated: July 25, 2011
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical Universtity of Lodz	Ministry of Science and Higher Education, Poland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Apocynin Did Not Cause Any Adverse Effect or influence blood pressure	3 months	Yes
Primary	Peripheral Blood Differential Count	Apocynin did not influence Peripheral Blood Differential Count and did not cause any adverse events	3 months	Yes
Primary	Lung function tests (spirometry)	Apocynin did not cause changes in lung function tests	3 months	Yes
Primary	Single Breath Carbon Monoxide Diffusing Capacity (DLCO)	Single breath DLCO was not modified by apocynin nebulization.	3 months	Yes
Secondary	Determination of H2O2	apocynin decreased H2O2 concentrations 60 and 120 minuter after nebulization in comparison to placebo	3 months	No
Secondary	Determination of NO3- concentration in Exhaled Breath Condensate	Apocynin did not influence NO3- concentration in Exhaled Breath Condensate	3 months	No
Secondary	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	No
Secondary	Determination of NO2- Concentration in Serum	No influence of apocynin on NO2- Concentration in Serum was observes	3 months	No
Secondary	Blood Pressure	No influence of apocynin on blood pressure was observed	3 months	Yes
Secondary	Peripheral Blood Differential Count	Apocynin Did Not Cause Any Adverse Effect or influence Peripheral Blood Differential Count	3 months	Yes
Secondary	Lung Functional Tests	Single breath DLCO was not modified by apocynin nebulization.	3 months	Yes
Secondary	Single Breath Carbon Monoxide Diffusing Capacity (DLCO)	Apocynin did not influence DLCO	3 months	Yes