Zileuton and Exhaled Nitric Oxide in Asthmatics - Full Text View

Sponsor:	Gelb, Arthur F., M.D.
Information provided by:	Gelb, Arthur F., M.D.
ClinicalTrials.gov Identifier:	NCT00575861

Purpose

Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair 250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.

Condition	Intervention	Phase
Asthma	Drug: zileuton	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics

Resource links provided by NLM:

MedlinePlus related topics: Asthma Gas

Drug Information available for: Nitric oxide Zileuton

U.S. FDA Resources

Further study details as provided by Gelb, Arthur F., M.D.:

Primary Outcome Measures:

nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide [ Time Frame: 2 hr to 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

expiratory spirometry and asthma symptom Juniper score [ Time Frame: 2 hr to 1 month ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	September 2005
Study Completion Date:	November 2007

Arms	Assigned Interventions
Active Comparator: 1 Advair 250/50 (baseline) fluticasone/salmeterol 250/50	Drug: zileuton zileuton (Zyflo) 600mg qid for 2hr and for 30 days Other Name: zyflo

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Non-smoking
Moderate to severe persistent asthmatics
Clinically stable X 6 weeks on Advair 250/50 bid for at least 12 months

Exclusion Criteria:

No leukotriene synthesis inhibitors or receptor antagonists for 6 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575861

Locations

United States, California
Arthur F Gelb Medical Corporation
Lakewood, California, United States, 90712

Sponsors and Collaborators

Gelb, Arthur F., M.D.

More Information

Publications:

Gelb AF, Flynn Taylor C, Shinar C, et al. Additive role of zileuton on total exhaled, bronchial, alveolar nitric oxide in non-atopic moderate to severe persistent asthmatics on fluticasone 250/salmeterol 50. Chest 2006;130:163S

Gelb AF, Flynn Taylor C, Shinar CM, Gutierrez C, Zamel N. Role of spirometry and exhaled nitric oxide to predict exacerbations in treated asthmatics. Chest. 2006 Jun;129(6):1492-9.

Gelb AF, Taylor CF, Nussbaum E, Gutierrez C, Schein A, Shinar CM, Schein MJ, Epstein JD, Zamel N. Alveolar and airway sites of nitric oxide inflammation in treated asthma. Am J Respir Crit Care Med. 2004 Oct 1;170(7):737-41. Epub 2004 Jun 30.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gelb AF, Taylor CF, Simmons M, Shinar C. Role of add-on zileuton on total exhaled, large airway, and small airway/alveolar nitric oxide in moderate-severe persistent adult asthmatics on fluticasone 250 microg/Salmeterol 50 microg. Pulm Pharmacol Ther. 2009 Dec;22(6):516-21. Epub 2009 May 23.

Responsible Party:	Arthur F. Gelb MD, Arthur F. Gelb Medical Corporation
ClinicalTrials.gov Identifier:	NCT00575861 History of Changes
Other Study ID Numbers:	2000, Critical Therapeutics, Inc.
Study First Received:	December 15, 2007
Last Updated:	December 18, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by Gelb, Arthur F., M.D.:

asthma
nitric oxide gas exchange
lung function

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Zileuton
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on February 09, 2012