Status:
COMPLETED
Safety Study of Zileuton Injection in Patients With Asthma
Lead Sponsor:
Critical Therapeutics
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief Summary
The prevalence of asthma continues to increase. Despite the large number of available therapies, many patients continue to require emergency deparment (ED) visits and intensive therapy. However, ED vi...
Eligibility Criteria
Inclusion
- Diagnosis of asthma
- Morning FEV1 of 40-80% of predicted normal
- Evidence post-bronchodilator increase in FEV1 of at least 15%
- Evidence of at least 10% increase in FEV1 within 3 hours after oral 600 mg zileuton dose
- Signed IRB approved informed consent
- Patients must be willing and able to withhold:
- short acting β2-agonists for at least 6 hours prior to spirometry
- inhaled corticosteroids (ICS) for at least 24 hours prior to sprirometry
- long acting β2-agonists (LABA) for 7 days and be willing and able to switch from a LABA/ICS combination product to a monotherapy ICS product
Exclusion
- Females of childbearing potential not using effective contracception
- Any uncontrolled systemic disease other than asthma
- Patient with known hypersensitivity to zileuton IR tablets or zileuton injection or any of the components found therein
- An upper or lower respiratory tract infection within 2 weeks of screening
- An ED visit or hospitalization for asthma within 3 months of screening
- Oral or parenteral corticosteroid use for asthma exacerbation within 3 months of screening
- Current cigarette smoker and/or \>10 pack-year smoking history
- History of hepatitis B (HBV) or hepatitis C infection or other active liver disease or chronic hepatitis
- Screening ALT \>1.5x ULN
- Patient with impaired renal function or serum creatinine \>1.5x ULN
- History of HIV infection
- History of drug or alcohol abuse within 1 year of screening
- Patient taking any of the following asthma/allergy medications:
- Anti-IgE meds within 3 months of screening
- Zileuton IR tablets within 1 month of screening
- Inhaled or oral steroids not stable for at least 1 month
- Theophylline, cromolyn, or nedocromil within 7 days of screening
- Leukotriene receptor agonists within 7 days of screening
- Warfarin, propranolol, inhaled or sytemic anticholinergics within 7 days of screening
- Long acting beta agonist within 7 days of screening
- Oral beta-2 agonists within 12 hours of screening
- Immunotherapy injections not in a stable dosing phase
- Female patient who is pregnant or breast-feeding or plans to become pregnant during the study period
- Participation in another research study within 30 days of screening
- Patient is the Investigator or other staff or relative who is directly involved in the conduct of the study
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00299065
Start Date
January 1 2006
End Date
June 1 2006
Last Update
September 26 2007
Active Locations (10)
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1
Allergy & Asthma Specialist Medical Group
Huntington Beach, California, United States, 92647
2
Allergy and Asthma Medical Group and Research Center
San Diego, California, United States, 92123
3
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, United States, 80112
4
Northeast Medical Research Associates
North Dartmouth, Massachusetts, United States, 02747