Inhaled Apocynin Decreases Reactive Oxygen Species Concentrations in Exhaled Breath Condensate in Mild Asthmatics

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00992667
First received: October 5, 2009
Last updated: October 8, 2009
Last verified: October 2009
  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

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • blood pressure, peripheral blood differential count, lung functional tests, single breath carbon monoxide diffusing capacity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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:
  • 4-hydroxy-3-methoxyacetophenone,
  • acetovanillone

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992667

Locations
Poland
Medical University of Lodz
Lodz, Lodzkie, Poland, 92-213
Sponsors and Collaborators
Medical Universtity of Lodz
Ministry of Science and Higher Education, Poland
Investigators
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 July 23, 2014