Zileuton and Exhaled Nitric Oxide in Asthmatics

NCT00575861 | Completed Phase 4 DMC

• 2 other identifiers: 2000Critical Therapeutics, Inc.
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

asthma; nitric oxide gas exchange; lung function

Outcome Measures

Primary Outcomes (1)

• nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide

  2 hr to 1 month

Secondary Outcomes (1)

• expiratory spirometry and asthma symptom Juniper score

  2 hr to 1 month

Study Arms (1)

1

ACTIVE COMPARATOR

Advair 250/50 (baseline) fluticasone/salmeterol 250/50

Drug: zileuton

Interventions

zileuton DRUG

zileuton (Zyflo) 600mg qid for 2hr and for 30 days

Also known as: zyflo

1

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No leukotriene synthesis inhibitors or receptor antagonists for 6 weeks

Sponsors & Collaborators

• Gelb, Arthur F., M.D.: lead

Study Sites (1)

Arthur F Gelb Medical Corporation

Lakewood, California, 90712, United States

Location

Related Publications (4)

• 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

  BACKGROUND

• 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. doi: 10.1378/chest.129.6.1492.

  PMID: 16778266 BACKGROUND

• 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. doi: 10.1164/rccm.200403-408OC. Epub 2004 Jun 30.

  PMID: 15229098 BACKGROUND

• 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.

  PMID: 19467341 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

zileuton

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: December 15, 2007
• First Posted: December 18, 2007
• Study Start: September 1, 2005
• Study Completion: November 1, 2007
• Last Updated: December 20, 2007

Record last verified: 2007-12

Locations

US (1)