AsthmaPhase 1/2NCT00299065
Safety Study of Zileuton Injection in Patients With Asthma
A Phase 1/2 study testing Zileuton injection in people with Asthma, run by Critical Therapeutics at 10 sites in United States.
Trial 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 visits continue to be a major contributor to the healthcare cost of asthma treatment. 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 injection
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2006to Jun 2006
- Phase
- Phase 1/2
- 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
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
Western Sky Medical Research
El Paso, Texas, 79902
Colorado Allergy and Asthma Centers, PC
Englewood, Colorado, 80112
Allergy & Asthma Specialist Medical Group
Huntington Beach, California, 92647
Clinical Research Institute
Minneapolis, Minnesota, 55402
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747
Allergy Associates Research Center
Portland, Oregon, 97213
Allergy and Asthma Medical Group and Research Center
San Diego, California, 92123
Princeton Center for Clinical Research
Skillman, New Jersey, 08558
The Clinical Research Center, L.L.C.
St Louis, Missouri, 63141
About this study
Official title: Assessment of Safety, Tolerability, and Pharmacokinetics of Zileuton Injection in Patients With Asthma
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 visits continue to be a major contributor to the healthcare cost of asthma treatment. In the United States alone, asthma is the 11th most common reason for ED visits, with ED visits and hospitalizations accounting for almost 50% of the healthcare cost for asthma. Additionally, while only 20% of asthmatics have had ED visits or hospitalizations, these patients account for over 80% of the direct costs for asthma treatment. Current National Asthma Education and Prevention Program (NAEPP) guidelines regarding management of acute asthma exacerbations in the ED setting include: oxygenation for most patients, inhaled short-acting β2-agonists and systemic corticosteroids.
Zileuton, a specific 5-lipoxygenase inhibitor, has been extensively studied in inflammatory diseases such as asthma, which involve leukotrienes as mediators of inflammation. Zileuton Immediate Release (IR) tablets (Zyflo®) were approved by the Food and Drug Administration (FDA) in December 1996 for the prevention and treatment of asthma in adults and children 12 years of age and older. The results of the 2 pivotal studies in asthmatics with zileuton IR tablets demonstrated that zileuton at a dose of 600 mg QID produced and maintained a lasting improvement of lung function. In addition to the lasting effect of zileuton, an acute bronchodilation (as early as 60 minutes) was observed after administration of the first 600 mg oral dose.
This acute bronchodilator effect may benefit patients during an acute exacerbation of asthma when added to the usual care in the ED or clinic setting. Critical Therapeutics has developed an injectable formulation of zileuton that will be explored for use in acute asthma exacerbations. This initial study is intended to provide PK data, information on safety and tolerability and some indication of pharmacologic activity as evidenced by lung function changes. In an attempt to enhance the potential for observing effects on lung function, only those patients with a demonstrated ability to respond by an increase in FEV1 of at least 10% within 3 hours after oral zileuton dosing will be enrolled.
- Conditions
- Asthma
- Being tested
- Zileuton injection
- Keywords
- Asthma, bronchial, Asthma, exercise-induced, Anti-asthmatic agents
- Medical subject headings
- Asthma, Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zileuton injectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical laboratory tests through 48 hours post-injection
Vital signs through 10 hours post-injection
Pulse oximetry through 10 hours post-injection
Injection site evaluations through 10 hours post-injection
Adverse event assessments through 48 hours post-injection
Blood samples for PK through 10 hours post-injection
Secondary outcomes (2)
Spirometry through 10 hours post-injection
Peak expiratory flow rates through 20 min. post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startJan 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Critical Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dana Hilt, MD, Study director, Critical Therapeutics Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299065
- Sponsor's protocol ID
- CTI-04-C05-201
- Status last verified
- Sep 2007
- First submitted
- 2 Mar 2006
- Last updated
- 26 Sep 2007
- Results posted
- No
Publications
Fuhlbrigge AL, Adams RJ, Guilbert TW, Grant E, Lozano P, Janson SL, Martinez F, Weiss KB, Weiss ST. The burden of asthma in the United States: level and distribution are dependent on interpretation of the national asthma education and prevention program guidelines. Am J Respir Crit Care Med. 2002 Oct 15;166(8):1044-9. doi: 10.1164/rccm.2107057.
PubMed 12379546Colice GL, Burgt JV, Song J, Stampone P, Thompson PJ. Categorizing asthma severity. Am J Respir Crit Care Med. 1999 Dec;160(6):1962-7. doi: 10.1164/ajrccm.160.6.9902112.
PubMed 10588614Rodrigo GJ, Rodrigo C, Hall JB. Acute asthma in adults: a review. Chest. 2004 Mar;125(3):1081-102. doi: 10.1378/chest.125.3.1081.
PubMed 15006973
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety, Tolerability, and Pharmacokinetics of Zileuton Injection in Patients With Asthma
- ClinicalTrials.gov ID
- NCT00299065
- Acronym / sponsor ID
- CTI-04-C05-201
- Conditions
- Asthma
- Keywords
- Asthma, bronchial, Asthma, exercise-induced, Anti-asthmatic agents
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Critical TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Jun 2006
- First posted
- 6 Mar 2006 (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.
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 visits continue to be a major contributor to the healthcare cost of asthma treatment. In the United States alone, asthma is the 11th most common reason for ED visits, with ED visits and hospitalizations accounting for almost 50% of the healthcare cost for asthma. Additionally, while only 20% of asthmatics have had ED visits or hospitalizations, these patients account for over 80% of the direct costs for asthma treatment. Current National Asthma Education and Prevention Program (NAEPP) guidelines regarding management of acute asthma exacerbations in the ED setting include: oxygenation for most patients, inhaled short-acting β2-agonists and systemic corticosteroids.
Zileuton, a specific 5-lipoxygenase inhibitor, has been extensively studied in inflammatory diseases such as asthma, which involve leukotrienes as mediators of inflammation. Zileuton Immediate Release (IR) tablets (Zyflo®) were approved by the Food and Drug Administration (FDA) in December 1996 for the prevention and treatment of asthma in adults and children 12 years of age and older. The results of the 2 pivotal studies in asthmatics with zileuton IR tablets demonstrated that zileuton at a dose of 600 mg QID produced and maintained a lasting improvement of lung function. In addition to the lasting effect of zileuton, an acute bronchodilation (as early as 60 minutes) was observed after administration of the first 600 mg oral dose.
This acute bronchodilator effect may benefit patients during an acute exacerbation of asthma when added to the usual care in the ED or clinic setting. Critical Therapeutics has developed an injectable formulation of zileuton that will be explored for use in acute asthma exacerbations. This initial study is intended to provide PK data, information on safety and tolerability and some indication of pharmacologic activity as evidenced by lung function changes. In an attempt to enhance the potential for observing effects on lung function, only those patients with a demonstrated ability to respond by an increase in FEV1 of at least 10% within 3 hours after oral zileuton dosing will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (25 listed)
- 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
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 |
|---|---|---|
| Zileuton injection | Drug | – |
Primary outcome
Clinical laboratory tests through 48 hours post-injection
Vital signs through 10 hours post-injection
Pulse oximetry through 10 hours post-injection
Injection site evaluations through 10 hours post-injection
Adverse event assessments through 48 hours post-injection
Blood samples for PK through 10 hours post-injection
2 secondary outcomes
Spirometry through 10 hours post-injection
Peak expiratory flow rates through 20 min. post-injection
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 26 Sep 2007.
- Background: PubMed 12379546Fuhlbrigge AL, Adams RJ, Guilbert TW, Grant E, Lozano P, Janson SL, Martinez F, Weiss KB, Weiss ST. The burden of asthma in the United States: level and distribution are dependent on interpretation of the national asthma education and prevention program guidelines. Am J Respir Crit Care Med. 2002 Oct 15;166(8):1044-9. doi: 10.1164/rccm.2107057.
- Background: PubMed 10588614Colice GL, Burgt JV, Song J, Stampone P, Thompson PJ. Categorizing asthma severity. Am J Respir Crit Care Med. 1999 Dec;160(6):1962-7. doi: 10.1164/ajrccm.160.6.9902112.
- Background: PubMed 15006973Rodrigo GJ, Rodrigo C, Hall JB. Acute asthma in adults: a review. Chest. 2004 Mar;125(3):1081-102. doi: 10.1378/chest.125.3.1081.
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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.
Dana Hilt, MD study director
Critical Therapeutics Incorporated
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zileuton injection in people with Asthma, run by Critical Therapeutics at 10 sites in United States.
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 9 inclusion and 25 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 26 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Clinical laboratory tests through 48 hours post-injection. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00299065, which also lists 3 linked publications.
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 26 Sep 2007.