Seasonal Allergic RhinitisPhase 3NCT00960141
A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
A Phase 3 study testing montelukast sodium and Comparator: loratadine in people with Seasonal Allergic Rhinitis, run by Organon and Co.
Trial summary
A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- montelukast sodium and Comparator: loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 829 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Nov 2000
- Phase
- Phase 3
- 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
- Patient is a non-smoker
- Patient is in good mental and physical health
Who cannot join
- Patient is hospitalized
- Patient is a woman who is <8 weeks postpartum or is breast feeding
- Patient intends to move or vacation away during the study
- Patient is a current or past abuser of alcohol or illicit drugs
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Fall Study
A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- montelukast sodium, Comparator: loratadine, Comparator: placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukast sodiumDrug
montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks
Comparator: loratadineDrug
loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks
Comparator: placeboDrug
placebo tablet, taken orally once daily at bed time for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | montelukast Receives: Drug: montelukast sodium |
| 2 | Active comparator | loratadine Receives: Drug: Comparator: loratadine |
| 3 | Placebo comparator | placebo Receives: Drug: Comparator: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Daytime Nasal Symptoms Score
Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.
Measured: Baseline and Week 2
Secondary outcomes (5)
Mean Change From Baseline in Nighttime Symptoms Score
Mean change from baseline in Nighttime Symptoms Score on a 4-point scale [0(best) to 3(worst)]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score.
Measured: Baseline and Week 2
Mean Change From Baseline in Daytime Eye Symptoms Score
Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.
Measured: Baseline and Week 2
Patient's Global Evaluation of Allergic Rhinitis
An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, in answer to a single question regarding the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
Measured: Week 2 (or upon discontinuation)
Physician's Global Evaluation of Allergic Rhinitis
An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
Measured: Week 2
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
Patients completed a validated, self-administered questionnaire, which included 28 questions on a 7-point scale [score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.
Measured: Baseline and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startAug 2000
- Primary completionOct 2000
- Study completionNov 2000
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 829 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
- NCT00960141
- Sponsor's protocol ID
- 0476-192
- Other IDs
- MK0476-192, 2009_633
- Status last verified
- Feb 2022
- First submitted
- 14 Aug 2009
- Last updated
- 3 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chervinsky P, Philip G, Malice MP, Bardelas J, Nayak A, Marchal JL, van Adelsberg J, Bousquet J, Tozzi CA, Reiss TF. Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies. Ann Allergy Asthma Immunol. 2004 Mar;92(3):367-73. doi: 10.1016/S1081-1206(10)61576-1.
PubMed 15049402
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Fall Study
- ClinicalTrials.gov ID
- NCT00960141
- Acronym / sponsor ID
- 0476-192
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 829 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- Primary completion
- Oct 2000 (actual)
- Study completion
- Nov 2000 (actual)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Posted 9 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: montelukast sodiummontelukast |
| 2 | Active comparator | Drug: Comparator: loratadineloratadine |
| 3 | Placebo comparator | Drug: Comparator: placeboplacebo |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
- Patient is a non-smoker
- Patient is in good mental and physical health
Key exclusion criteria (4 listed)
- Patient is hospitalized
- Patient is a woman who is <8 weeks postpartum or is breast feeding
- Patient intends to move or vacation away during the study
- Patient is a current or past abuser of alcohol or illicit drugs
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 |
|---|---|---|
| montelukast sodiummontelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks | Drug | 1 |
| Comparator: loratadineloratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks | Drug | 2 |
| Comparator: placeboplacebo tablet, taken orally once daily at bed time for 2 weeks | Drug | 3 |
Primary outcome
Mean Change From Baseline in Daytime Nasal Symptoms Score
Time frame: Baseline and Week 2
Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.
5 secondary outcomes
Mean Change From Baseline in Nighttime Symptoms Score
Time frame: Baseline and Week 2
Mean Change From Baseline in Daytime Eye Symptoms Score
Time frame: Baseline and Week 2
Patient's Global Evaluation of Allergic Rhinitis
Time frame: Week 2 (or upon discontinuation)
Physician's Global Evaluation of Allergic Rhinitis
Time frame: Week 2
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score
Time frame: Baseline and Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 15049402Chervinsky P, Philip G, Malice MP, Bardelas J, Nayak A, Marchal JL, van Adelsberg J, Bousquet J, Tozzi CA, Reiss TF. Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies. Ann Allergy Asthma Immunol. 2004 Mar;92(3):367-73. doi: 10.1016/S1081-1206(10)61576-1.
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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 montelukast sodium and Comparator: loratadine in people with Seasonal Allergic Rhinitis, 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 3 inclusion and 4 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 Feb 2022. 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. 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 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?
Yes. Results are posted in the registry (first posted 9 Jun 2010). 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?
Mean Change From Baseline in Daytime Nasal Symptoms Score (time frame: Baseline and Week 2). 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 NCT00960141, 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 3 Feb 2022.