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Seasonal Allergic RhinitisPhase 3NCT00963599

Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

A Phase 3 study testing Comparator: montelukast/loratadine, Comparator: montelukast 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 evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo. 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?
Comparator: montelukast/loratadine, Comparator: montelukast 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
907 participants
Where
No sites listed yet
Study dates
Sep 1999to Nov 1999
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 seasonal 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 less than 8 weeks postpartum or is breast-feeding
  • Patient intends to move or vacation away during the study
  • Patient has had any major surgery within 4 weeks of study start
  • Patient is a current or past abuser of alcohol or illicit drugs
  • Patient has been treated in an emergency room for asthma in the past month
  • Patient had an upper respiratory infection with in 3 weeks prior to study start
  • Patient has any active pulmonary disorder other than asthma

About this study

Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study

This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.

Being tested
Comparator: montelukast/loratadine, Comparator: montelukast, 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.

  • Comparator: montelukast/loratadineDrug

    montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks

  • Comparator: montelukastDrug

    montelukast 10 mg tablet taken once daily at bed time for 2 weeks

  • Comparator: loratadineDrug

    loratadine 10 mg tablet taken once daily at bed time for 2 weeks

  • Comparator: placeboDrug

    placebo tablet taken once daily at bed time for 2 weeks

Study groups in NCT00963599
Study groupRoleWhat they receive
1Experimentalmontelukast/loratadine
Receives: Drug: Comparator: montelukast/loratadine
2Experimentalloratadine
Receives: Drug: Comparator: loratadine
3Experimentalmontelukast
Receives: Drug: Comparator: montelukast
4Placebo 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

    Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (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 Week 2

Secondary outcomes (11)

  1. Mean Change From Baseline in Nighttime Symptoms Score

    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), 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 Week 2

  2. Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)

    Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).

    Measured: Baseline and Week 2

  3. Mean Change From Baseline in Daytime Eye Symptoms Score

    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 (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 Week 2

  4. Mean Change From Baseline in Daytime Nasal Congestion Score

    Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).

    Measured: Baseline and Week 2

  5. Mean Change From Baseline in Daytime Rhinorrhea Score

    Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).

    Measured: Baseline and Week 2

  6. Mean Change From Baseline in Daytime Nasal Itching Score

    Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).

    Measured: Baseline and Week 2

  7. Mean Change From Baseline in Daytime Sneezing Score

    Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).

    Measured: Baseline and Week 2

  8. Mean Change From Baseline in Nasal Congestion Upon Awakening

    Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).

    Measured: Baseline and Week 2

  9. 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, 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

  10. 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

  11. Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score

    Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.

    Measured: Week 2

Timeline

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

  1. First posted21 Aug 2009 (estimated)
  2. Study startSep 1999
  3. Primary completionNov 1999
  4. Study completionNov 1999

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
907 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00963599
Sponsor's protocol ID
0476A-117
Other IDs
MK0476A-117, 2009_645
Status last verified
Feb 2022
First submitted
19 Aug 2009
Last updated
9 Feb 2022

Publications

  • Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol. 2002 Jun;88(6):592-600. doi: 10.1016/S1081-1206(10)61891-1.

    PubMed 12086367

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Comparator: montelukast/loratadine, Comparator: montelukast 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 8 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 9 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 (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 NCT00963599, 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 9 Feb 2022.

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