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

NCT00992667 | Completed Phase 1

• 1 other identifier: Nowak-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bronchial Asthma

Keywords

apocynin; asthma

Outcome Measures

Primary Outcomes (1)

• blood pressure, peripheral blood differential count, lung functional tests, single breath carbon monoxide diffusing capacity

  6 months

Secondary Outcomes (1)

• 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

  6 months

Study Arms (1)

Asthmatics

EXPERIMENTAL

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

Interventions

Apocynin nebulization DRUG

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.)

Also known as: 4-hydroxy-3-methoxyacetophenone,, acetovanillone

Asthmatics

Eligibility Criteria

• Age: 22 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead
• Ministry of Science and Higher Education, Poland: collaborator

Study Sites (1)

Medical University of Lodz

Lodz, Łódź Voivodeship, 92-213, Poland

Location

Related Publications (6)

• Horvath I, Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, Becher G, van Beurden WJ, Corradi M, Dekhuijzen R, Dweik RA, Dwyer T, Effros R, Erzurum S, Gaston B, Gessner C, Greening A, Ho LP, Hohlfeld J, Jobsis Q, Laskowski D, Loukides S, Marlin D, Montuschi P, Olin AC, Redington AE, Reinhold P, van Rensen EL, Rubinstein I, Silkoff P, Toren K, Vass G, Vogelberg C, Wirtz H; ATS/ERS Task Force on Exhaled Breath Condensate. Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J. 2005 Sep;26(3):523-48. doi: 10.1183/09031936.05.00029705.

  PMID: 16135737 BACKGROUND

• Bateman ED, Hurd SS, Barnes PJ, Bousquet J, Drazen JM, FitzGerald JM, Gibson P, Ohta K, O'Byrne P, Pedersen SE, Pizzichini E, Sullivan SD, Wenzel SE, Zar HJ. Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J. 2008 Jan;31(1):143-78. doi: 10.1183/09031936.00138707.

  PMID: 18166595 BACKGROUND

• Dziedzic B, Mazanowska-Gajdowicz J, Walczewska A, Sarniak A, Nowak D. Comparison of cadmium and enzyme-catalyzed nitrate reduction for determination of NO2-/NO3- in breath condensate. Clin Chim Acta. 2003 Sep;335(1-2):65-74. doi: 10.1016/s0009-8981(03)00277-8.

  PMID: 12927686 BACKGROUND

• Peters EA, Hiltermann JT, Stolk J. Effect of apocynin on ozone-induced airway hyperresponsiveness to methacholine in asthmatics. Free Radic Biol Med. 2001 Dec 1;31(11):1442-7. doi: 10.1016/s0891-5849(01)00725-0.

  PMID: 11728816 RESULT

• Nowak D, Kalucka S, Bialasiewicz P, Krol M. Exhalation of H2O2 and thiobarbituric acid reactive substances (TBARs) by healthy subjects. Free Radic Biol Med. 2001 Jan 15;30(2):178-86. doi: 10.1016/s0891-5849(00)00457-3.

  PMID: 11163535 RESULT

• Gage MC, Thippeswamy T. Inhibitors of Src Family Kinases, Inducible Nitric Oxide Synthase, and NADPH Oxidase as Potential CNS Drug Targets for Neurological Diseases. CNS Drugs. 2021 Jan;35(1):1-20. doi: 10.1007/s40263-020-00787-5. Epub 2021 Jan 30.

  PMID: 33515429 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

acetovanillone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Rafal Pawliczak, MD, PhD

  Medical University of Lodz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 9, 2009
• Study Start: June 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: November 1, 2008
• Last Updated: October 9, 2009

Record last verified: 2009-10

Locations

PL (1)