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

Medical University of Lodz

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Apocynin and placebo nebulization

Study type: Interventional

Funder types: Other

Identifiers

NCT01402297

Nowak-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

13 participants in 1 patient group

COPD patients

Experimental group

Description:

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.

Treatment:

Drug: Apocynin and placebo nebulization