Zileuton CR vs Placebo in Poorly Controlled Asthma Patients on Moderate Dose ICS

April 1, 2008 updated by: Critical Therapeutics

A Randomized, Double-Blind, Placebo Controlled Study of Zileuton CR Tablets Versus Placebo in Adult Patients With Poorly Controlled Asthma Patients on Moderate Dose Inhaled Corticosteroids (ICS)

Asthma is a chronic inflammatory disorder of the airways with a variety of inflammatory processes contributing to the pathogenesis. The inflammation leads to a state of increased airway responsiveness and reversible airway obstruction that causes the recurrent symptoms of asthma. Despite the variety of treatments available for asthma, none are curative, and the disease continues to place a burden on society in terms of morbidity, reduced quality of life (QOL), and ever increasing healthcare costs. The prevalence of asthma continues to increase with current data suggesting that since 1980, adult asthma cases have increased by 75% and in children under 5 years of age the prevalence has increased by 160%.1 Additionally, studies have suggested that the disease severity has been underestimated and that more patients may be classified as having moderate to severe persistent disease.2 Inhaled corticosteroids (ICS) have been the cornerstone of anti-inflammatory treatment for decades and have been shown to improve lung function, decrease symptoms, and reduce asthma exacerbations.3 However, many patients are still inadequately controlled despite treatment according to current asthma management guidelines and have a significant unmet medical need. Such patients are at high risk of serious exacerbations and asthma-related mortality.4 Combining long-acting β2-agonists (LABAs) with low dose ICS has been shown to improve asthma control over using higher doses of ICS alone. However, LABAs act mainly at the bottom of the inflammatory cascade and there are concerns that they may mask underlying inflammation.5 Recently, leukotriene receptor antagonists have been added to ICS as second-line therapy in the management of asthma. Zileuton has been extensively studied in inflammatory diseases such as asthma, in which leukotrienes mediate inflammation.

The aim of this study is to assess the effect of zileuton controlled-release (CR; 1200 mg 2-times daily [BID]) on pulmonary function, asthma control, and symptomatic response in adult patients with asthma poorly controlled on moderate dose ICS.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

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
      • Lexington, Massachusetts, United States, 02421
        • Critical Therapeutics

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

8 years to 66 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female 12-70 years of age (inclusive).
  2. Diagnosis of asthma for at least 6 months.
  3. Morning FEV1 of 40-80% normal.
  4. Demonstrated reversible airflow restriction.
  5. Non-smokers.
  6. On moderate doses of ICS with inadequate asthma control.
  7. Signed ICF

Exclusion Criteria:

  1. Diagnosis of COPD.
  2. Uncontrolled systemic illness.
  3. Hypersensitivity to any component of ZYFLO CR
  4. Any patient with an unscheduled visit to an ER or hospital for asthma exacerbation within past 3 months.
  5. History of hepatitis or active liver disease.
  6. ALT greater than 3xULN.
  7. History of HIV infection
  8. Recent history of drug or alcohol abuse.
  9. Oral corticosteroids within one month, cromolyn sodium or nedocromil within 14 days, theophylline, LABA, ZYFLO, or leukotriene modifiers, warfarin or propranolol, inhaled anti-cholinergics, or combination LABA/ICS.
  10. Omalizumab within 3 months.
  11. Pregnant female.
  12. Participation with 30 days in investigational study.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo tablets 2x600mg BID for 24 weeks
Experimental: 1
Zileuton CR
Drug: Zileuton CR
Zileuton CR tablets 2x600mg BID for 24 weeks
Other Names:
  • ZYFLO CR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary function measures
Time Frame: 3 and 6 months
3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Asthma exacerbations, ACQ, AQLQ, safety
Time Frame: 3 and 6 months
3 and 6 months

Collaborators and Investigators

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

Sponsor

Critical Therapeutics

Investigators

  • Study Director: Cornelis Wortel, MD, PhD, Critical Therapeutics/Clinquest Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

July 1, 2007

Primary Completion (Anticipated)

May 1, 2008

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

June 13, 2007

First Submitted That Met QC Criteria

June 13, 2007

First Posted (Estimate)

June 14, 2007

Study Record Updates

Last Update Posted (Estimate)

April 3, 2008

Last Update Submitted That Met QC Criteria

April 1, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTI-03-C07-401

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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