AsthmaPhase 4NCT01805687
Single Dose Bronchodilatory Study in Asthma
A Phase 4 study testing Zileuton extended release in people with Asthma, run by Cornerstone Therapeutics Inc. at 1 site in United States.
Trial summary
Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- Zileuton extended release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of asthma for at least 5 years
- FEV1 of 50-85% predicted
- Reversible airway obstruction
Who cannot join
- Pregnant/nursing females
- Liver function tests greater than upper limit of normal
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747
About this study
Official title: A Single-Center, Open-Label, Single-Dose Evaluation of the Duration and Extent of Bronchodilation Following Administration of Zileuton CR 1200 mg in Subjects With Stable, Chronic Asthma
Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.
- Conditions
- Asthma
- Being tested
- Zileuton extended release
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zileuton extended releaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Zileuton extended release | Other | Oral, 1200 mg (2 x 600 mg tablets) Receives: Drug: Zileuton extended release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in FEV1
Measured: 12 Hours
Secondary outcomes (2)
Area Under the Curve (AUC)
Measured: 72 Hours
Number of Subjects With Adverse Events
Measured: 72 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornerstone Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805687
- Sponsor's protocol ID
- CRTX 082-04-01
- Status last verified
- Aug 2014
- First submitted
- 5 Mar 2013
- Last updated
- 3 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Single-Dose Evaluation of the Duration and Extent of Bronchodilation Following Administration of Zileuton CR 1200 mg in Subjects With Stable, Chronic Asthma
- ClinicalTrials.gov ID
- NCT01805687
- Acronym / sponsor ID
- CRTX 082-04-01
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cornerstone Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Posted 18 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the bronchodilator effects of Zyflo CR in patients with chronic stable asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zileuton extended release | Other | Drug: Zileuton extended releaseOral, 1200 mg (2 x 600 mg tablets) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of asthma for at least 5 years
- FEV1 of 50-85% predicted
- Reversible airway obstruction
Key exclusion criteria (2 listed)
- Pregnant/nursing females
- Liver function tests greater than upper limit of normal
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 extended release | Drug | Zileuton extended release |
Primary outcome
Change From Baseline in FEV1
Time frame: 12 Hours
2 secondary outcomes
Area Under the Curve (AUC)
Time frame: 72 Hours
Number of Subjects With Adverse Events
Time frame: 72 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Asthma
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 extended release in people with Asthma, run by Cornerstone Therapeutics Inc. 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 2 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 3 Sep 2014. 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?
Yes. Results are posted in the registry (first posted 18 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in FEV1 (time frame: 12 Hours). 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 Sep 2014.