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Zileuton and Exhaled Nitric Oxide in Asthmatics

NCT ID: NCT00575861

Last Updated: 2007-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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asthma nitric oxide gas exchange lung function

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

zileuton

Intervention Type DRUG

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

Interventions

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zileuton

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

Intervention Type DRUG

Other Intervention Names

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zyflo

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gelb, Arthur F., M.D.

INDIV

Sponsor Role lead

Responsible Party

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Arthur F. Gelb Medical Corporation

Locations

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Arthur F Gelb Medical Corporation

Lakewood, California, United States

Site Status

Countries

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United States

References

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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

Reference Type 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.

Reference Type BACKGROUND
PMID: 16778266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15229098 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19467341 (View on PubMed)

Other Identifiers

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Critical Therapeutics, Inc.

Identifier Type: -

Identifier Source: secondary_id

2000

Identifier Type: -

Identifier Source: org_study_id