AsthmaPhase 4NCT00486343
Zileuton CR vs Placebo in Poorly Controlled Asthma Patients on Moderate Dose ICS
A Phase 4 study testing Zileuton CR in people with Asthma, run by Critical Therapeutics at 1 site in United States.
Trial summary
Asthma is a chronic inflammatory disorder of the airways with a variety of inflammatory processes contributing to the pathogenesis. The inflammation leads to a state of increased airway responsiveness and reversible airway obstruction that causes the recurrent symptoms of asthma. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Zileuton CR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2008
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female 12-70 years of age (inclusive).
- Diagnosis of asthma for at least 6 months.
- Morning FEV1 of 40-80% normal.
- Demonstrated reversible airflow restriction.
- Non-smokers.
- On moderate doses of ICS with inadequate asthma control.
- Signed ICF
Who cannot join
- Diagnosis of COPD.
- Uncontrolled systemic illness.
- Hypersensitivity to any component of ZYFLO CR
- Any patient with an unscheduled visit to an ER or hospital for asthma exacerbation within past 3 months.
- History of hepatitis or active liver disease.
- ALT greater than 3xULN.
Show all 12Show fewer
- History of HIV infection
- Recent history of drug or alcohol abuse.
- Oral corticosteroids within one month, cromolyn sodium or nedocromil within 14 days, theophylline, LABA, ZYFLO, or leukotriene modifiers, warfarin or propranolol, inhaled anti-cholinergics, or combination LABA/ICS.
- Omalizumab within 3 months.
- Pregnant female.
- Participation with 30 days in investigational study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Critical Therapeutics
Lexington, Massachusetts, 02421
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Study of Zileuton CR Tablets Versus Placebo in Adult Patients With Poorly Controlled Asthma Patients on Moderate Dose Inhaled Corticosteroids (ICS)
Asthma is a chronic inflammatory disorder of the airways with a variety of inflammatory processes contributing to the pathogenesis. The inflammation leads to a state of increased airway responsiveness and reversible airway obstruction that causes the recurrent symptoms of asthma. Despite the variety of treatments available for asthma, none are curative, and the disease continues to place a burden on society in terms of morbidity, reduced quality of life (QOL), and ever increasing healthcare costs. The prevalence of asthma continues to increase with current data suggesting that since 1980, adult asthma cases have increased by 75% and in children under 5 years of age the prevalence has increased by 160%.1 Additionally, studies have suggested that the disease severity has been underestimated and that more patients may be classified as having moderate to severe persistent disease.2 Inhaled corticosteroids (ICS) have been the cornerstone of anti-inflammatory treatment for decades and have been shown to improve lung function, decrease symptoms, and reduce asthma exacerbations.3 However, many patients are still inadequately controlled despite treatment according to current asthma management guidelines and have a significant unmet medical need. Such patients are at high risk of serious exacerbations and asthma-related mortality.4 Combining long-acting β2-agonists (LABAs) with low dose ICS has been shown to improve asthma control over using higher doses of ICS alone. However, LABAs act mainly at the bottom of the inflammatory cascade and there are concerns that they may mask underlying inflammation.5 Recently, leukotriene receptor antagonists have been added to ICS as second-line therapy in the management of asthma. Zileuton has been extensively studied in inflammatory diseases such as asthma, in which leukotrienes mediate inflammation.
The aim of this study is to assess the effect of zileuton controlled-release (CR; 1200 mg 2-times daily [BID]) on pulmonary function, asthma control, and symptomatic response in adult patients with asthma poorly controlled on moderate dose ICS.
- Conditions
- Asthma
- Being tested
- Zileuton CR, Placebo
- Keywords
- Asthma, ICS, 5-LO Inhibition, Leukotrienes, Asthma control, Asthma exacerbations
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zileuton CRDrug
Also called ZYFLO CR
Zileuton CR tablets 2x600mg BID for 24 weeks
PlaceboDrug
Placebo tablets 2x600mg BID for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Zileuton CR Receives: Drug: Zileuton CR |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function measures
Measured: 3 and 6 months
Secondary outcomes (1)
Asthma exacerbations, ACQ, AQLQ, safety
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2008 (estimated)
- Study completionJun 2008 (estimated)
Why it stopped: Slower than anticipated enrollment
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Critical Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Cornelis Wortel, MD, PhD, Study director, Critical Therapeutics/Clinquest Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486343
- Sponsor's protocol ID
- CTI-03-C07-401
- Status last verified
- Apr 2008
- First submitted
- 13 Jun 2007
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Study of Zileuton CR Tablets Versus Placebo in Adult Patients With Poorly Controlled Asthma Patients on Moderate Dose Inhaled Corticosteroids (ICS)
- ClinicalTrials.gov ID
- NCT00486343
- Acronym / sponsor ID
- CTI-03-C07-401
- Conditions
- Asthma
- Keywords
- Asthma, ICS, 5-LO Inhibition, Leukotrienes, Asthma control, Asthma exacerbations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slower than anticipated enrollment
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Critical TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- May 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 14 Jun 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.
Asthma is a chronic inflammatory disorder of the airways with a variety of inflammatory processes contributing to the pathogenesis. The inflammation leads to a state of increased airway responsiveness and reversible airway obstruction that causes the recurrent symptoms of asthma. Despite the variety of treatments available for asthma, none are curative, and the disease continues to place a burden on society in terms of morbidity, reduced quality of life (QOL), and ever increasing healthcare costs. The prevalence of asthma continues to increase with current data suggesting that since 1980, adult asthma cases have increased by 75% and in children under 5 years of age the prevalence has increased by 160%.1 Additionally, studies have suggested that the disease severity has been underestimated and that more patients may be classified as having moderate to severe persistent disease.2 Inhaled corticosteroids (ICS) have been the cornerstone of anti-inflammatory treatment for decades and have been shown to improve lung function, decrease symptoms, and reduce asthma exacerbations.3 However, many patients are still inadequately controlled despite treatment according to current asthma management guidelines and have a significant unmet medical need. Such patients are at high risk of serious exacerbations and asthma-related mortality.4 Combining long-acting β2-agonists (LABAs) with low dose ICS has been shown to improve asthma control over using higher doses of ICS alone. However, LABAs act mainly at the bottom of the inflammatory cascade and there are concerns that they may mask underlying inflammation.5 Recently, leukotriene receptor antagonists have been added to ICS as second-line therapy in the management of asthma. Zileuton has been extensively studied in inflammatory diseases such as asthma, in which leukotrienes mediate inflammation.
The aim of this study is to assess the effect of zileuton controlled-release (CR; 1200 mg 2-times daily [BID]) on pulmonary function, asthma control, and symptomatic response in adult patients with asthma poorly controlled on moderate dose ICS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Zileuton CRZileuton CR |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female 12-70 years of age (inclusive).
- Diagnosis of asthma for at least 6 months.
- Morning FEV1 of 40-80% normal.
- Demonstrated reversible airflow restriction.
- Non-smokers.
Key exclusion criteria (12 listed)
- Diagnosis of COPD.
- Uncontrolled systemic illness.
- Hypersensitivity to any component of ZYFLO CR
- Any patient with an unscheduled visit to an ER or hospital for asthma exacerbation within past 3 months.
- History of hepatitis or active liver disease.
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 CRAlso: ZYFLO CRZileuton CR tablets 2x600mg BID for 24 weeks | Drug | 1 |
| PlaceboPlacebo tablets 2x600mg BID for 24 weeks | Drug | 2 |
Primary outcome
Pulmonary function measures
Time frame: 3 and 6 months
1 secondary outcome
Asthma exacerbations, ACQ, AQLQ, safety
Time frame: 3 and 6 months
Results and safety
The study was stopped early (reason given: Slower than anticipated enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2008.
- Specific Educational Information on Zileuton CR (Zyflo CR)Link provided by the sponsor.
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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.
Cornelis Wortel, MD, PhD study director
Critical Therapeutics/Clinquest Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zileuton CR in people with Asthma, run by Critical Therapeutics at 1 site 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 3 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Slower than anticipated enrollment). Results are not available in the source record.
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?
Pulmonary function measures (time frame: 3 and 6 months). 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 3 Apr 2008.