AsthmaPhase 2NCT00534625
Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma Patients
A Phase 2 study testing zileuton in people with Asthma, run by Critical Therapeutics.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- zileuton
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Mar 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
About this study
Official title: Phase 2 Study of the Assessment of Pulmonary Function, Safety, Tolerability, and PK of Zileuton Injection in Patients With Chronic Stable Asthma
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
- Being tested
- zileuton, placebo
- Keywords
- Asthma, exacerbation, pulmonary function
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zileutonDrug
Single injection of zileuton 150 mg
placeboDrug
Single injection of placebo
zileutonDrug
Single injection of zileuton 300 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: placebo |
| 2 | Experimental | 150 mg zileuton by intravenous injection Receives: Drug: zileuton |
| 3 | Experimental | 300 mg zileuton by intravenous injection Receives: Drug: zileuton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on pulmonary function
Measured: Within 0-12 hours after single dose
Secondary outcomes (1)
Safety assessments
Measured: Within 0-36 hours after single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Critical Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Cees Wortel, Study director, Critical Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534625
- Sponsor's protocol ID
- CTI-04-C07-202
- Status last verified
- Mar 2008
- First submitted
- 24 Sep 2007
- Last updated
- 21 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the Assessment of Pulmonary Function, Safety, Tolerability, and PK of Zileuton Injection in Patients With Chronic Stable Asthma
- ClinicalTrials.gov ID
- NCT00534625
- Acronym / sponsor ID
- CTI-04-C07-202
- Conditions
- Asthma
- Keywords
- Asthma, exacerbation, pulmonary function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Critical TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo |
| 2 | Experimental | Drug: zileuton150 mg zileuton by intravenous injection |
| 3 | Experimental | Drug: zileuton300 mg zileuton by intravenous injection |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zileutonSingle injection of zileuton 150 mg | Drug | 2 |
| placeboSingle injection of placebo | Drug | 1 |
| zileutonSingle injection of zileuton 300 mg | Drug | 3 |
Primary outcome
Effect on pulmonary function
Time frame: Within 0-12 hours after single dose
1 secondary outcome
Safety assessments
Time frame: Within 0-36 hours after single dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Cees Wortel study director
Critical Therapeutics
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zileuton in people with Asthma, run by Critical Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on pulmonary function (time frame: Within 0-12 hours after single dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2008.