Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients

NCT00534625 | Completed Phase 2

• 1 other identifier: CTI-04-C07-202
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

A single intravenous injection of zileuton (150 or 300 mg) will be administered to patients with stable asthma. The goals will be to determine if zileuton i.v. can produce a rapid increase in FEV1/PEFR and when this effect can be seen. The safety of this route of administration of zileuton will also be studied. PK will be obtained in a population based method.

Conditions

Asthma

Keywords

Asthma, exacerbation, pulmonary function

Outcome Measures

Primary Outcomes (1)

• Effect on pulmonary function

  Within 0-12 hours after single dose

Secondary Outcomes (1)

• Safety assessments

  Within 0-36 hours after single dose

Study Arms (3)

1

PLACEBO COMPARATOR

Drug: placebo

2

EXPERIMENTAL

150 mg zileuton by intravenous injection

Drug: zileuton

3

EXPERIMENTAL

300 mg zileuton by intravenous injection

Drug: zileuton

Interventions

zileuton DRUG

Single injection of zileuton 150 mg

2

placebo DRUG

Single injection of placebo

1

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 12 years of age or older
• Diagnosis of asthma by current ATS guidelines
• FEV1 of 4-80%.
• Reversibility of at least 13% after bronchodilator treatment
• Must be willing to with hold SABA for 6 hours and ICS for 24 hours prior to treatment.
• Informed consent

You may not qualify if:

• Females of child bearing potential unless using birth control
• Uncontrolled systemic disease
• Known hypersensitivity to zileuton or components of zileuton injection.
• Upper or lower respiratory tract infection within the last 2 weeks
• Admission to hospital or ER visit for asthma exacerbation within the last 3 months
• Course of oral or parenteral steroids within the last 3 months
• Current smoker or H/O \> 15 pack years
• Creatinine \> 1.5 x ULN
• ALT \> 3 x ULN
• BP \< 100 (systolic)
• H/O HIV
• H/O alcohol or drug abuse
• Patients taking Xolair, theophylline, montelukast, zafirlukast, nedocromil, cromolyn sodium, Zyflo (within the past 7 days), warfarin, propranolol, inhaled anti-cholinergics, or LABA.
• Pregnant or breast feeding females
• Current participation or participation in an experimental drug study within 30 days.

Sponsors & Collaborators

• Critical Therapeutics: lead

MeSH Terms

Conditions

Asthma

Interventions

zileuton

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Cees Wortel

  Critical Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 21, 2008

Record last verified: 2008-03