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

Asthma Clinical Trial

Official title:

Phase 2 Study of the Assessment of Pulmonary Function, Safety, Tolerability, and PK of Zileuton Injection in Patients With Chronic Stable Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534625
• Other study ID #: CTI-04-C07-202
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2007
• Last updated: March 19, 2008
• Start date: September 2007
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: Critical Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patients 12 years of age or older

2. Diagnosis of asthma by current ATS guidelines

3. FEV1 of 4-80%.

4. Reversibility of at least 13% after bronchodilator treatment

5. Must be willing to with hold SABA for 6 hours and ICS for 24 hours prior to treatment.

6. Informed consent

Exclusion Criteria:

1. Females of child bearing potential unless using birth control

2. Uncontrolled systemic disease

3. Known hypersensitivity to zileuton or components of zileuton injection.

4. Upper or lower respiratory tract infection within the last 2 weeks

5. Admission to hospital or ER visit for asthma exacerbation within the last 3 months

6. Course of oral or parenteral steroids within the last 3 months

7. Current smoker or H/O > 15 pack years

8. Creatinine > 1.5 x ULN

9. ALT > 3 x ULN

10. BP < 100 (systolic)

11. H/O HIV

12. H/O alcohol or drug abuse

13. Patients taking Xolair, theophylline, montelukast, zafirlukast, nedocromil, cromolyn sodium, Zyflo (within the past 7 days), warfarin, propranolol, inhaled anti-cholinergics, or LABA.

14. Pregnant or breast feeding females

15. Current participation or participation in an experimental drug study within 30 days.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• zileuton
Single injection of zileuton 150 mg
• placebo
Single injection of placebo
• zileuton
Single injection of zileuton 300 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Critical Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on pulmonary function		Within 0-12 hours after single dose	No
Secondary	Safety assessments		Within 0-36 hours after single dose	Yes