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Completed

NCT Number: NCT00979901

Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

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

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season
  • Patient is a nonsmoker and has been a nonsmoker for at least 1 year
  • Patient is in good general health

Exclusion criteria

  • 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

Treatment and study plan

Comparator: montelukast

Drug

10 mg montelukast tablet given once daily at bedtime for 2 weeks

Comparator: loratadine

Drug

10 mg loratadine tablet given once daily at bedtime for 2 weeks

Comparator: placebo

Drug

placebo tablet given once daily at bedtime for 2 weeks

Comparator: montelukast/loratadine

Drug

montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks

Primary outcomes

  1. Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks

    Time frame: Baseline and Week 2

    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. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal

    Symptoms Score. Scores were measured as 0 (best) to 3 (worst).

Secondary outcomes

  1. Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks

    Time frame: Baseline and Week 2

    Mean change from baseline in Nighttime Symptoms Score.

    Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst).

  2. Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks

    Time frame: Baseline and Week 2

    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. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst).

  3. Patient's Global Evaluation of Allergic Rhinitis at Week 2

    Time frame: Week 2

    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. Scores were measured as 0 (best) to 6 (worst).

  4. Physician's Global Evaluation of Allergic Rhinitis at Week 2

    Time frame: Week 2

    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. Scores were measured as 0 (best) to 6 (worst).

  5. Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2

    Time frame: Week 2

    Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst).

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Seasonal Allergic Rhinitis--Spring Study

Important dates

Study start
2000
Primary completion
2000
Study completion
2000
First posted
Sep 18, 2009
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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