Seasonal Allergic RhinitisPhase 3NCT00963469
Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)
A Phase 3 study testing montelukast sodium and Comparator: loratadine in people with Seasonal Allergic Rhinitis, run by Organon and Co.
Trial summary
This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. 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
- 1,079 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Nov 2001
- 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 history of seasonal allergic rhinitis that worsens during the study season
- Patient is a nonsmoker
- Patient is in good health physical and mental health
Who cannot join
- Patient is hospitalized
- Patient is a woman who is < 8 weeks postpartum or is breastfeeding
- Patient plans to move or vacation away during the study
- Patient has had any major surgery with in past 4 weeks
- 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 Over a 4-Week Treatment Period-Fall 2001
This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. 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 orally once daily in the morning for 4 weeks
Comparator: loratadineDrug
loratadine 10 mg tablet orally once daily in the morning for 4 weeks
Comparator: placeboDrug
placebo tablet orally once daily in the morning for 4 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 Over First 2 Weeks of Treatment Period
Mean change from baseline in Daytime Nasal Symptoms Score.
Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
Measured: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Secondary outcomes (6)
Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period
Mean change from baseline in Nighttime Symptoms Score.
Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worse)], and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
Measured: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period
Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)].
Measured: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period
Mean change from baseline in Daytime Eye Symptoms scores.
Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.
Measured: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.
Measured: After first 2 weeks of treatment
Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.
Measured: After first 2 weeks of treatment
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period
Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire-28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each domain were averaged, then scores for the 7 domains were averaged for an overall score.
Measured: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startAug 2001
- Primary completionNov 2001
- Study completionNov 2001
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
- 1,079 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
- NCT00963469
- Sponsor's protocol ID
- 0476-240
- Other IDs
- MK0476-240, 2009_647
- Status last verified
- Feb 2022
- First submitted
- 19 Aug 2009
- Last updated
- 3 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
van Adelsberg J, Philip G, Pedinoff AJ, Meltzer EO, Ratner PH, Menten J, Reiss TF; Montelukast Fall Rhinitis Study Group. Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period. Allergy. 2003 Dec;58(12):1268-76. doi: 10.1046/j.1398-9995.2003.00261.x.
PubMed 14616102
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 Over a 4-Week Treatment Period-Fall 2001
- ClinicalTrials.gov ID
- NCT00963469
- Acronym / sponsor ID
- 0476-240
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,079 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Nov 2001 (actual)
- Study completion
- Nov 2001 (actual)
- First posted
- 21 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.
This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. 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 history of seasonal allergic rhinitis that worsens during the study season
- Patient is a nonsmoker
- Patient is in good health physical and mental health
Key exclusion criteria (5 listed)
- Patient is hospitalized
- Patient is a woman who is < 8 weeks postpartum or is breastfeeding
- Patient plans to move or vacation away during the study
- Patient has had any major surgery with in past 4 weeks
- 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 orally once daily in the morning for 4 weeks | Drug | 1 |
| Comparator: loratadineloratadine 10 mg tablet orally once daily in the morning for 4 weeks | Drug | 2 |
| Comparator: placeboplacebo tablet orally once daily in the morning for 4 weeks | Drug | 3 |
Primary outcome
Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period
Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Mean change from baseline in Daytime Nasal Symptoms Score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
6 secondary outcomes
Mean Change From Baseline in Nighttime Symptoms Score Over First 2 Weeks of Treatment Period
Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period
Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period
Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)
Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
Time frame: After first 2 weeks of treatment
Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment
Time frame: After first 2 weeks of treatment
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period
Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of 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.
- Background: PubMed 14616102van Adelsberg J, Philip G, Pedinoff AJ, Meltzer EO, Ratner PH, Menten J, Reiss TF; Montelukast Fall Rhinitis Study Group. Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period. Allergy. 2003 Dec;58(12):1268-76. doi: 10.1046/j.1398-9995.2003.00261.x.
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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 5 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 Over First 2 Weeks of Treatment Period (time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of 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 NCT00963469, 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; AzTrials last refreshed its copy on 7 Nov 2026.