AsthmaPhase 4NCT00575861
Zileuton and Exhaled Nitric Oxide in Asthmatics
A Phase 4 study testing zileuton in people with Asthma, run by Gelb, Arthur F., M.D. at 1 site in United States.
Trial summary
Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair 250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven pathways of inflammation. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- zileuton
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Nov 2007
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-smoking
- Moderate to severe persistent asthmatics
- Clinically stable X 6 weeks on Advair 250/50 bid for at least 12 months
Who cannot join
- No leukotriene synthesis inhibitors or receptor antagonists for 6 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur F Gelb Medical Corporation
Lakewood, California, 90712
About this study
Official title: Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics
Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair 250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.
- Conditions
- Asthma
- Being tested
- zileuton
- Keywords
- asthma, nitric oxide gas exchange, lung 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
Also called zyflo
zileuton (Zyflo) 600mg qid for 2hr and for 30 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Advair 250/50 (baseline) fluticasone/salmeterol 250/50 Receives: Drug: zileuton |
What is being measured
The primary outcome is the main question the study is designed to answer.
nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide
Measured: 2 hr to 1 month
Secondary outcomes (1)
expiratory spirometry and asthma symptom Juniper score
Measured: 2 hr to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startSep 2005
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gelb, Arthur F., M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575861
- Sponsor's protocol ID
- 2000
- Other IDs
- Critical Therapeutics, Inc.
- Status last verified
- Dec 2007
- First submitted
- 15 Dec 2007
- Last updated
- 20 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gelb AF, Flynn Taylor C, Shinar C, et al. Additive role of zileuton on total exhaled, bronchial, alveolar nitric oxide in non-atopic moderate to severe persistent asthmatics on fluticasone 250/salmeterol 50. Chest 2006;130:163S
Gelb AF, Flynn Taylor C, Shinar CM, Gutierrez C, Zamel N. Role of spirometry and exhaled nitric oxide to predict exacerbations in treated asthmatics. Chest. 2006 Jun;129(6):1492-9. doi: 10.1378/chest.129.6.1492.
PubMed 16778266Gelb AF, Taylor CF, Nussbaum E, Gutierrez C, Schein A, Shinar CM, Schein MJ, Epstein JD, Zamel N. Alveolar and airway sites of nitric oxide inflammation in treated asthma. Am J Respir Crit Care Med. 2004 Oct 1;170(7):737-41. doi: 10.1164/rccm.200403-408OC. Epub 2004 Jun 30.
PubMed 15229098Gelb AF, Taylor CF, Simmons M, Shinar C. Role of add-on zileuton on total exhaled, large airway, and small airway/alveolar nitric oxide in moderate-severe persistent adult asthmatics on fluticasone 250 microg/Salmeterol 50 microg. Pulm Pharmacol Ther. 2009 Dec;22(6):516-21. doi: 10.1016/j.pupt.2009.05.003. Epub 2009 May 23.
PubMed 19467341
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Additive Effects of Zileuton to Advair on Total Exhaled, Bronchial, and Alveolar Nitric Oxide in Asthmatics
- ClinicalTrials.gov ID
- NCT00575861
- Acronym / sponsor ID
- 2000
- Conditions
- Asthma
- Keywords
- asthma, nitric oxide gas exchange, lung function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Gelb, Arthur F., M.D.
- Study start
- Sep 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 18 Dec 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.
Evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on Advair 250/50 bid. Since asthma is an endogenous inflammatory disease there usually is increased total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven pathways of inflammation. The addition of zileuton which is a leukotriene synthesis inhibitor by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: zileutonAdvair 250/50 (baseline) fluticasone/salmeterol 250/50 |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-smoking
- Moderate to severe persistent asthmatics
- Clinically stable X 6 weeks on Advair 250/50 bid for at least 12 months
Key exclusion criteria (1 listed)
- No leukotriene synthesis inhibitors or receptor antagonists for 6 weeks
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 |
|---|---|---|
| zileutonAlso: zyflozileuton (Zyflo) 600mg qid for 2hr and for 30 days | Drug | 1 |
Primary outcome
nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide
Time frame: 2 hr to 1 month
1 secondary outcome
expiratory spirometry and asthma symptom Juniper score
Time frame: 2 hr to 1 month
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 20 Dec 2007.
- BackgroundGelb AF, Flynn Taylor C, Shinar C, et al. Additive role of zileuton on total exhaled, bronchial, alveolar nitric oxide in non-atopic moderate to severe persistent asthmatics on fluticasone 250/salmeterol 50. Chest 2006;130:163S
- Background: PubMed 16778266Gelb AF, Flynn Taylor C, Shinar CM, Gutierrez C, Zamel N. Role of spirometry and exhaled nitric oxide to predict exacerbations in treated asthmatics. Chest. 2006 Jun;129(6):1492-9. doi: 10.1378/chest.129.6.1492.
- Background: PubMed 15229098Gelb AF, Taylor CF, Nussbaum E, Gutierrez C, Schein A, Shinar CM, Schein MJ, Epstein JD, Zamel N. Alveolar and airway sites of nitric oxide inflammation in treated asthma. Am J Respir Crit Care Med. 2004 Oct 1;170(7):737-41. doi: 10.1164/rccm.200403-408OC. Epub 2004 Jun 30.
- Derived from this study: PubMed 19467341Gelb AF, Taylor CF, Simmons M, Shinar C. Role of add-on zileuton on total exhaled, large airway, and small airway/alveolar nitric oxide in moderate-severe persistent adult asthmatics on fluticasone 250 microg/Salmeterol 50 microg. Pulm Pharmacol Ther. 2009 Dec;22(6):516-21. doi: 10.1016/j.pupt.2009.05.003. Epub 2009 May 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Asthma, run by Gelb, Arthur F., M.D. 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 3 inclusion and 1 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 20 Dec 2007. 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. 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 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?
nitric oxide gas exchange including total exhaled nitric oxide, bronchial and alveolar nitric oxide (time frame: 2 hr to 1 month). 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 NCT00575861, which also lists 4 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 20 Dec 2007.