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OpenTrials
Completed

NCT Number: NCT01805687

Single Dose Bronchodilatory Study in Asthma

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

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northeast Medical Research Associates

North Dartmouth, Massachusetts, 02747, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zileuton extended release

Drug

Primary outcomes

  1. Change From Baseline in FEV1

    Time frame: 12 Hours

Secondary outcomes

  1. Area Under the Curve (AUC)

    Time frame: 72 Hours

  2. Number of Subjects With Adverse Events

    Time frame: 72 Hours

Sponsors and collaborators

Lead sponsor

Cornerstone Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
First posted
Mar 6, 2013
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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