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NCT Number: NCT00972738

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

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.

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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 season 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 <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

Treatment and study plan

montelukast sodium

Drug

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

Comparator: loratadine

Drug

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

Comparator: placebo

Drug

placebo tablet orally once daily at bedtime for 2 weeks

Primary outcomes

  1. 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

    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.

Secondary outcomes

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: Baseline and at the end of 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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multi-Center, Double-blind, Randomized, Parallel-Group Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Spring 2001 Study

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Sep 7, 2009
Registry last updated
Feb 3, 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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