Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Slower than anticipated enrollment)
Sponsor:
Information provided by:
Critical Therapeutics
ClinicalTrials.gov Identifier:
NCT00486343
First received: June 13, 2007
Last updated: April 1, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Zileuton CR
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Critical Therapeutics:

Primary Outcome Measures:
  • Pulmonary function measures [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Asthma exacerbations, ACQ, AQLQ, safety [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: July 2007
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Zileuton CR
Drug: Zileuton CR
Zileuton CR tablets 2x600mg BID for 24 weeks
Other Name: ZYFLO CR
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo tablets 2x600mg BID for 24 weeks

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486343

Locations
United States, Massachusetts
Critical Therapeutics
Lexington, Massachusetts, United States, 02421
Sponsors and Collaborators
Critical Therapeutics
Investigators
Study Director: Cornelis Wortel, MD, PhD Critical Therapeutics/Clinquest Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Cornelis Wortel MD PhD/Acting CMO, Critical Therapeutics/Clinquest Inc
ClinicalTrials.gov Identifier: NCT00486343     History of Changes
Other Study ID Numbers: CTI-03-C07-401
Study First Received: June 13, 2007
Last Updated: April 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Critical Therapeutics:
Asthma
ICS
5-LO Inhibition
Leukotrienes
Asthma control
Asthma exacerbations

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Zileuton
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Lipoxygenase Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014