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Completed

NCT Number: NCT00963599

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

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.

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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
  • 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
  • Patient has any active pulmonary disorder other than asthma

Treatment and study plan

Comparator: montelukast/loratadine

Drug

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

Comparator: montelukast

Drug

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

Comparator: loratadine

Drug

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

Comparator: placebo

Drug

placebo tablet taken once daily at bed time for 2 weeks

Primary outcomes

  1. Mean Change From Baseline in Daytime Nasal Symptoms Score

    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 (0 (best) to 3 (worst)). The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.

Secondary outcomes

  1. Mean Change From Baseline in Nighttime Symptoms Score

    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 (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.

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

    Time frame: Baseline and Week 2

    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)).

  3. Mean Change From Baseline in Daytime Eye Symptoms Score

    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 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.

  4. Mean Change From Baseline in Daytime Nasal Congestion Score

    Time frame: Baseline and Week 2

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

  5. Mean Change From Baseline in Daytime Rhinorrhea Score

    Time frame: Baseline and Week 2

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

  6. Mean Change From Baseline in Daytime Nasal Itching Score

    Time frame: Baseline and Week 2

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

  7. Mean Change From Baseline in Daytime Sneezing Score

    Time frame: Baseline and Week 2

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

  8. Mean Change From Baseline in Nasal Congestion Upon Awakening

    Time frame: Baseline and Week 2

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

  9. Patient's Global Evaluation of Allergic Rhinitis

    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. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).

  10. Physician's Global Evaluation of Allergic Rhinitis

    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. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).

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

    Time frame: Week 2

    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.

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 Effect of Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study

Important dates

Study start
1999
Primary completion
1999
Study completion
1999
First posted
Aug 21, 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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