Rhinitis, Allergic, SeasonalPhase 3NCT00092885
An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)
A Phase 3 study testing MK0476, montelukast sodium in people with Rhinitis, Allergic, Seasonal and Asthma, Bronchial, run by Organon and Co.
Trial summary
The purpose of this study is to determine the effect of an approved medication on the symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis and asthma. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Asthma, Bronchial
- What is being tested?
- MK0476, montelukast sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 831 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Oct 2003
- Phase
- Phase 3
- 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Non-smoker
- A 2-year documented history of seasonal allergic rhinitis
- A 1-year documented history of chronic asthma
- Positive allergy testing
Who cannot join
- Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
About this study
Official title: A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of Montelukast on Allergic Rhinitis in Patients With Seasonal Allergic Rhinitis and Chronic Asthma
The purpose of this study is to determine the effect of an approved medication on the symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis and asthma.
Read the detailed description
The duration of treatment is 2 weeks.
- Conditions
- Rhinitis, Allergic, Seasonal, Asthma, Bronchial
- Being tested
- MK0476, montelukast sodium, Comparator: placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0476, montelukast sodiumDrug
Comparator: placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score
Secondary outcomes (1)
(1) Rhinoconjunctivitis Quality-of-Life Questionnaire overall score; (2) Global Evaluation of Allergic Rhinitis by Patient; (3) Global Evaluation of Allergic Rhinitis by Physician
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2004 (estimated)
- Study startMar 2003
- Primary completionOct 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00092885
- Sponsor's protocol ID
- 0476-269
- Other IDs
- 2004_025
- Status last verified
- Feb 2022
- First submitted
- 23 Sep 2004
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Philip G, Nayak AS, Berger WE, Leynadier F, Vrijens F, Dass SB, Reiss TF. The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis. Curr Med Res Opin. 2004 Oct;20(10):1549-58. doi: 10.1185/030079904x3348.
PubMed 15462688
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of Montelukast on Allergic Rhinitis in Patients With Seasonal Allergic Rhinitis and Chronic Asthma
- ClinicalTrials.gov ID
- NCT00092885
- Acronym / sponsor ID
- 0476-269
- Conditions
- Rhinitis, Allergic, Seasonal, Asthma, Bronchial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 28 Sep 2004 (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 study is to determine the effect of an approved medication on the symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis and asthma.
Detailed description
The duration of treatment is 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Non-smoker
- A 2-year documented history of seasonal allergic rhinitis
- A 1-year documented history of chronic asthma
- Positive allergy testing
Key exclusion criteria (1 listed)
- Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
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 |
|---|---|---|
| MK0476, montelukast sodium | Drug | – |
| Comparator: placebo | Drug | – |
Primary outcome
Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score
1 secondary outcome
(1) Rhinoconjunctivitis Quality-of-Life Questionnaire overall score; (2) Global Evaluation of Allergic Rhinitis by Patient; (3) Global Evaluation of Allergic Rhinitis by Physician
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 15 Aug 2024.
- Background: PubMed 15462688Philip G, Nayak AS, Berger WE, Leynadier F, Vrijens F, Dass SB, Reiss TF. The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis. Curr Med Res Opin. 2004 Oct;20(10):1549-58. doi: 10.1185/030079904x3348.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0476, montelukast sodium in people with Rhinitis, Allergic, Seasonal and Asthma, Bronchial, run by Organon and Co.
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 4 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 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score. 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 NCT00092885, which also lists 1 linked publication.
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 15 Aug 2024.