Chronic Obstructive Pulmonary Disease
Conditions
Keywords
apocynin, COPD
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.
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.
Interventions
DRUGApocynin 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.)
Sponsors
Ministry of Science and Higher Education, Poland
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 3 months | Apocynin Did Not Cause Any Adverse Effect or influence blood pressure |
| Peripheral Blood Differential Count | 3 months | Apocynin did not influence Peripheral Blood Differential Count and did not cause any adverse events |
| Lung function tests (spirometry) | 3 months | Apocynin did not cause changes in lung function tests |
| Single Breath Carbon Monoxide Diffusing Capacity (DLCO) | 3 months | Single breath DLCO was not modified by apocynin nebulization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 3 months | No influence of apocynin on blood pressure was observed |
| Peripheral Blood Differential Count | 3 months | Apocynin Did Not Cause Any Adverse Effect or influence Peripheral Blood Differential Count |
| Determination of H2O2 | 3 months | apocynin decreased H2O2 concentrations 60 and 120 minuter after nebulization in comparison to placebo |
| Single Breath Carbon Monoxide Diffusing Capacity (DLCO) | 3 months | Apocynin did not influence DLCO |
| Lung Functional Tests | 3 months | Single breath DLCO was not modified by apocynin nebulization. |
| Determination of NO3- concentration in Exhaled Breath Condensate | 3 months | Apocynin did not influence NO3- concentration in Exhaled Breath Condensate |
| Determination of NO2- concentration in Exhaled Breath Condensate | 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 | 3 months | No influence of apocynin on NO2- Concentration in Serum was observes |
Outcome results
None listed