Single Dose Bronchodilatory Study in Asthma

August 22, 2014 updated by: Cornerstone Therapeutics Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Northeast Medical Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Zileuton extended release
Oral, 1200 mg (2 x 600 mg tablets)
Drug: Zileuton extended release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in FEV1
Time Frame: 12 Hours
12 Hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Area Under the Curve (AUC)
Time Frame: 72 Hours
72 Hours
Number of Subjects With Adverse Events
Time Frame: 72 Hours
72 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornerstone Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 5, 2013

First Posted (Estimate)

March 6, 2013

Study Record Updates

Last Update Posted (Estimate)

September 3, 2014

Last Update Submitted That Met QC Criteria

August 22, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRTX 082-04-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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