Single Dose Bronchodilatory Study in Asthma

Phase 4CompletedNCT01805687

Cornerstone Therapeutics Inc.25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

Zileuton extended releaseDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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 (1)

Northeast Medical Research Associates

North Dartmouth, Massachusetts, United States

Outcomes

Primary Outcomes

Change From Baseline in FEV1

Time frame: 12 Hours

Secondary Outcomes

Area Under the Curve (AUC)

Time frame: 72 Hours

Number of Subjects With Adverse Events

Time frame: 72 Hours

Data from ClinicalTrials.gov

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