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Completed

NCT Number: NCT00963469

Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)

This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active control.

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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 history of seasonal allergic rhinitis that worsens during the study season
  • Patient is a nonsmoker
  • Patient is in good health physical and mental health

Exclusion criteria

  • Patient is hospitalized
  • Patient is a woman who is < 8 weeks postpartum or is breastfeeding
  • Patient plans to move or vacation away during the study
  • Patient has had any major surgery with in past 4 weeks
  • 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 in the morning for 4 weeks

Comparator: loratadine

Drug

loratadine 10 mg tablet orally once daily in the morning for 4 weeks

Comparator: placebo

Drug

placebo tablet orally once daily in the morning for 4 weeks

Primary outcomes

  1. Mean Change From Baseline in Daytime Nasal Symptoms Score Over First 2 Weeks of Treatment Period

    Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

    Mean change from baseline in Daytime Nasal Symptoms Score.

    Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4- point scale [Score 0 (best) to 3 (worse)]. 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 First 2 Weeks of Treatment Period

    Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

    Mean change from baseline in Nighttime Symptoms Score.

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

  2. Mean Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) Over First 2 Weeks of Treatment Period

    Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of Week 2)

    Composite Symptoms Scores were computed as the average of Daytime Nasal Scores [Score 0 (best) to 3 (worst)] and Nighttime Symptoms Scores [Score 0 (best) to 3 (worst)].

  3. Mean Change From Baseline in Daytime Eye Symptoms Score Over First 2 Weeks of Treatment Period

    Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of 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 [Score 0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score.

  4. Patient's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment

    Time frame: After first 2 weeks of treatment

    An evaluation by the patient, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.

  5. Physician's Global Evaluation of Allergic Rhinitis After First 2 Weeks of Treatment

    Time frame: After first 2 weeks of treatment

    An evaluation by the physician, administered after the first 2 weeks of treatment using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.

  6. Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After First 2 Weeks of Treatment Period

    Time frame: Baseline and first 2 Weeks of treatment period (from randomization through the end of 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: activity,sleep,non-nose/eye symptoms,practical problems,nasal symptoms, eye symptoms, and emotions. The scores for each 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 Montelukast in Patients With Seasonal Allergic Rhinitis Over a 4-Week Treatment Period-Fall 2001

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Aug 21, 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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