Inhaled Apocynin Decreases Reactive Oxygen Species Concentrations in Exhaled Breath Condensate in Mild Asthmatics
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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 10 nonsmoking mild asthmatics. Effects of nebulized apocynin (0.5 mg/ml, 6 ml) are assessed in exhaled breath condensate (EBC) after 30, 60 and 120 minutes.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchial Asthma |
Drug: Apocynin 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, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Inhaled Apocynin Decreases Reactive Oxygen Species Concentrations in Exhaled Breath Condensate in Mild Asthmatics |
- blood pressure, peripheral blood differential count, lung functional tests, single breath carbon monoxide diffusing capacity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- determination of H2O2, NO2- and NO3- concentrations in exhaled breath condensate, determination of NO2 concentration in serum, blood pressure, peripheral blood differential count, lung functional tests, single breath carbon monoxide diffusing capacity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 10 |
| Study Start Date: | June 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Asthmatics
Ten nonsmoking patients, suffering from mild bronchial asthma participated in the study (mean age 30±9 years, 5 men, 5 women). Asthma was diagnosed based on GINA 2008 criteria. The patients were free of any medication, at least 7 days before, and had not suffered from any infectious diseases including upper respiratory tract infections for at least 3 months prior to the study. Patients who did not meet these criteria were excluded from the study.
|
Drug: Apocynin nebulization
6 ml of apocynin of total dose 3 mg (0.5 mg/ml dissolved in sterile 0.9% NaCl as the study drug) 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:
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Detailed Description:
The study had a double-blind, placebo-controlled, cross-over design, consisted of 2 visits, separated 30 ± 10 days. If during the first visit the drug was used, in the second visit - placebo or vice versa. Before and after procedure, safety measures (arterial blood pressure, heart rate value, and cough scale) were performed. The effect of a possible inhibitor of ROS formation was performed using corticosteroid-naive asthmatic subjects, which are more prone to oxidative stress than healthy non-smoking subjects. The study protocol was approved by the Ethics Committee of Medical University of Lodz (no. RNN/12/08/KE) and written consent was obtained from every subject prior to the study.
EBC was collected using a modification of the method described previously by Doniec et al.2005. The subjects breathed spontaneously through a mouthpiece for 20 min. Each subject wore a nose clip during this procedure. Approximately 2 ml of condensate was collected and immediately stored at −80°C until the procedure of H2O2, NO2- and NO3- measurement.
6 ml of apocynin of total dose 3 mg (0.5 mg/ml) has been nebulized through the mouthpiece with using of a nose clip.
The H2O2 concentration in EBC was measured according to the method applied previously by Nowak et al.2001. Determination of NO2- and NO3- with Griess solution was performed by micromethod, carried out in 96-well plates, according to Griess' method, modified the method described by Dziedzic et al.2003.
Eligibility| Ages Eligible for Study: | 22 Years to 56 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients suffering from bronchial asthma (mild)
- patients free of any medication at least 7 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 moderate or severe asthma
- patients taking medication 7 or less days before the study
- infectious diseases that had occurred 3 months or less before the study
Contacts and Locations| Poland | |
| Medical University of Lodz | |
| Lodz, Lodzkie, Poland, 92-213 | |
| Principal Investigator: | Rafal Pawliczak, MD, PhD | Medical University of Lodz |
More Information
Publications:
| Responsible Party: | Rafal Pawliczak, Medical University of Lodz |
| ClinicalTrials.gov Identifier: | NCT00992667 History of Changes |
| Other Study ID Numbers: | Nowak-01 |
| Study First Received: | October 5, 2009 |
| Last Updated: | October 8, 2009 |
| Health Authority: | Poland: Ministry of Science and Higher Education |
Keywords provided by Medical Universtity of Lodz:
|
apocynin asthma |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Acetovanillone Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013