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Zileuton and Exhaled Nitric Oxide in Asthmatics

Information source: Gelb, Arthur F., M.D.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: zileuton (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Gelb, Arthur F., M.D.


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.

Clinical Details

Official title: Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics

Study design: Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide

Secondary outcome: expiratory spirometry and asthma symptom Juniper score


Minimum age: 21 Years. Maximum age: 80 Years. Gender(s): Both.


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

Locations and Contacts

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

Related publications:

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. doi: 10.1016/j.pupt.2009.05.003. Epub 2009 May 23.

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.

Starting date: September 2005
Last updated: December 18, 2007

Page last updated: August 23, 2015

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