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Seasonal Allergic RhinitisPhase 3NCT00972738

Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

A Phase 3 study testing montelukast sodium and Comparator: loratadine in people with Seasonal Allergic Rhinitis, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator. 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
1,214 participants
Where
No sites listed yet
Study dates
Apr 2001to Jul 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 documented history of season allergic rhinitis symptoms that flare up during the study season
  • Patient is a nonsmoker
  • Patient is in good general health

Who cannot join

  • Patient is hospitalized
  • Patient is a woman who is <8 weeks postpartum or is breast-feeding
  • Patient has had major surgery in the past 4 weeks
  • 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 Multi-Center, Double-blind, Randomized, Parallel-Group Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Spring 2001 Study

This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.

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 at bedtime for 2 weeks.

  • Comparator: loratadineDrug

    Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.

  • Comparator: PlaceboDrug

    placebo tablet orally once daily at bedtime for 2 weeks

Study groups in NCT00972738
Study groupRoleWhat they receive
1Experimentalmontelukast
Receives: Drug: montelukast sodium
2Active comparatorloratadine
Receives: Drug: Comparator: loratadine
3Placebo comparatorplacebo
Receives: Drug: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period

    Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.

    Measured: Baseline and over the 2-week treatment period

Secondary outcomes (5)

  1. Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period

    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score.

    Measured: Baseline and over the 2-week treatment period

  2. Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period

    Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale [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 over the 2-week treatment period

  3. Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period

    An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.

    Measured: End of the 2-week treatment period

  4. Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period

    An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study.

    Measured: End of the 2-week treatment period

  5. Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period

    Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life 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 individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score.

    Measured: Baseline and at the end of 2-week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2009 (estimated)
  2. Study startApr 2001
  3. Primary completionJul 2001
  4. Study completionJul 2001

Resources

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
1,214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00972738
Sponsor's protocol ID
0476-235
Other IDs
MK0476-235, 2009_658
Status last verified
Feb 2022
First submitted
4 Sep 2009
Last updated
3 Feb 2022
Data monitoring committee
No

Publications

  • van Adelsberg J, Philip G, LaForce CF, Weinstein SF, Menten J, Malice MP, Reiss TF; Montelukast Spring Rhinitis Investigator Group. Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2003 Feb;90(2):214-22. doi: 10.1016/S1081-1206(10)62144-8.

    PubMed 12602669

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 16 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 the 2-week Treatment Period (time frame: Baseline and over the 2-week treatment period). 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 NCT00972738, 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.

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