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Single Dose Bronchodilatory Study in Asthma

Information source: Cornerstone Therapeutics Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Zileuton extended release (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Cornerstone Therapeutics Inc.

Summary

Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.

Clinical Details

Official title: A Single-Center, Open-Label, Single-Dose Evaluation of the Duration and Extent of Bronchodilation Following Administration of Zileuton CR 1200 mg in Subjects With Stable, Chronic Asthma

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in FEV1

Secondary outcome:

Area Under the Curve (AUC)

Number of Subjects With Adverse Events

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of asthma for at least 5 years

- FEV1 of 50-85% predicted

- Reversible airway obstruction

Exclusion Criteria:

- Pregnant/nursing females

- Liver function tests greater than upper limit of normal

Locations and Contacts

Northeast Medical Research Associates, North Dartmouth, Massachusetts 02747, United States
Additional Information

Starting date: March 2013
Last updated: August 22, 2014

Page last updated: August 23, 2015

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