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Completed

NCT Number: NCT00974571

Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.

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Key information

Conditions

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

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 clinical history of perennial allergic rhinitis
  • 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 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 6 weeks

Comparator: cetirizine

Drug

cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks

Comparator: placebo

Drug

placebo tablet orally once daily at bedtime for 6 weeks

Primary outcomes

  1. Mean Change From Baseline in Daytime Nasal Symptoms Score

    Time frame: Baseline and first 4 weeks of a 6-week treatment period

    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 (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 first 4 weeks in 6-week treatment period

    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 (worst)], and the average 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

    Time frame: Baseline and first 4 weeks in 6-week treatment period

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

  3. Patient's Global Evaluation of Allergic Rhinitis

    Time frame: End of the first 4 weeks in 6-week treatment period

    An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.

  4. Physician's Global Evaluation of Allergic Rhinitis

    Time frame: End of the first 4 weeks in 6-week treatment period

    An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Sep 10, 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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