RhinitisPhase 4NCT00406094
Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
A Phase 4 study testing montelukast in people with Rhinitis, run by Bernstein, Jonathan A., M.D. at 1 site in United States.
Trial summary
The purpose of this trial is to determine if patients with NARES treated with montelukast (Singulair) will have improved nasal symptom scores and reduced nasal eosinophils. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis
- What is being tested?
- montelukast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 - 65 years
- Diagnosed with NARES
Who cannot join
- Smokers, exposed to passive smoke
- Diagnosis of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), or vasomotor rhinitis (VMR)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bernstein Allergy Group
Cincinnati, Ohio, 45231
Jonathan A Bernstein, MD, 513-931-0775, bernsteincrc@fuse.net
Jonathan A Bernstein, MD
About this study
Official title: The Evaluation of Singulair for the Treatment of Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
The purpose of this trial is to determine if patients with NARES treated with montelukast (Singulair) will have improved nasal symptom scores and reduced nasal eosinophils.
Read the detailed description
Patients will receive either montelukast or placebo in the treatment of NARES. 4 visits will be conducted over 12 weeks. A history and physical will be performed at the beginning of the trial and at the end. Skin testing will be done at Visit 1. Nasal smears and lavages will be performed at every visit. Patients will be compensated for time and travel.
- Conditions
- Rhinitis
- Being tested
- montelukast, placebo
- Keywords
- NARES, eosinophils, nasal symptoms
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukastDrug
Also called Singulair
10mg
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | montelukast Receives: Drug: montelukast |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES
Measured: December 2008
Determine whether montelukast is more effective than placebo at reducing nasal symptom scores
Measured: December 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bernstein, Jonathan A., M.D.
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Jonathan A Bernstein, MD, Principal investigator, Bernstein Allergy Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406094
- Sponsor's protocol ID
- NARES
- Status last verified
- Jan 2009
- First submitted
- 30 Nov 2006
- Last updated
- 16 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Singulair for the Treatment of Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
- ClinicalTrials.gov ID
- NCT00406094
- Acronym / sponsor ID
- NARES
- Conditions
- Rhinitis
- Keywords
- NARES, eosinophils, nasal symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Bernstein, Jonathan A., M.D.
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2006
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 4 Dec 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 purpose of this trial is to determine if patients with NARES treated with montelukast (Singulair) will have improved nasal symptom scores and reduced nasal eosinophils.
Detailed description
Patients will receive either montelukast or placebo in the treatment of NARES. 4 visits will be conducted over 12 weeks. A history and physical will be performed at the beginning of the trial and at the end. Skin testing will be done at Visit 1. Nasal smears and lavages will be performed at every visit. Patients will be compensated for time and travel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: montelukastmontelukast |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 - 65 years
- Diagnosed with NARES
Key exclusion criteria (2 listed)
- Smokers, exposed to passive smoke
- Diagnosis of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), or vasomotor rhinitis (VMR)
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 |
|---|---|---|
| montelukastAlso: Singulair10mg | Drug | 1 |
| placeboplacebo | Drug | 2 |
Primary outcome
Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES
Time frame: December 2008
Determine whether montelukast is more effective than placebo at reducing nasal symptom scores
Time frame: December 2008
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2009.
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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.
Jonathan A Bernstein, MD principal investigator
Bernstein Allergy Group
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 montelukast in people with Rhinitis, run by Bernstein, Jonathan A., 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 2 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: status not confirmed, as of the sponsor's last update on 16 Jan 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan A Bernstein, MD (513-931-0775, bernsteincrc@fuse.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES (time frame: December 2008). The study lists 2 primary outcomes in all. 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 16 Jan 2009.