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Single Dose Bronchodilatory Study in Asthma

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ClinicalTrials.gov Identifier: NCT01805687
Recruitment Status : Completed
First Posted : March 6, 2013
Results First Posted : August 18, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Cornerstone Therapeutics Inc.

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Zileuton extended release Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2013
Actual Primary Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Zileuton

Arms and Interventions
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Arm Intervention/treatment
Zileuton extended release
Oral, 1200 mg (2 x 600 mg tablets)
 Drug: Zileuton extended release


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in FEV1 [ Time Frame: 12 Hours ]

Secondary Outcome Measures :
  1. Area Under the Curve (AUC) [ Time Frame: 72 Hours ]
  2. Number of Subjects With Adverse Events [ Time Frame: 72 Hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805687


Locations
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United States, Massachusetts
Northeast Medical Research Associates
North Dartmouth, Massachusetts, United States, 02747
Sponsors and Collaborators
Cornerstone Therapeutics Inc.
More Information
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Responsible Party: Cornerstone Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01805687    
Other Study ID Numbers: CRTX 082-04-01
First Posted: March 6, 2013    Key Record Dates
Results First Posted: August 18, 2014
Last Update Posted: September 3, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Zileuton
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists