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

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

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

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Comparator: montelukast; Drug: Comparator: loratadine; Drug: Comparator: placebo; Drug: Comparator: montelukast/loratadine

• Study Type: Interventional
• Enrollment (Actual): 1577
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 85 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 3; placebo	Drug: Comparator: placebo; placebo tablet given once daily at bedtime for 2 weeks
EXPERIMENTAL: 1; montelukast	Drug: Comparator: montelukast; 10 mg montelukast tablet given once daily at bedtime for 2 weeks
EXPERIMENTAL: 2; loratadine	Drug: Comparator: loratadine; 10 mg loratadine tablet given once daily at bedtime for 2 weeks
EXPERIMENTAL: 4; montelukast/loratadine	Drug: Comparator: montelukast/loratadine; montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks	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).	Baseline and Week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks	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).	Baseline and Week 2
Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks	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).	Baseline and Week 2
Patient's Global Evaluation of Allergic Rhinitis at 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).	Week 2
Physician's Global Evaluation of Allergic Rhinitis at 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).	Week 2
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at 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).	Week 2

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Philip G, Malmstrom K, Hampel FC, Weinstein SF, LaForce CF, Ratner PH, Malice MP, Reiss TF; Montelukast Spring Rhinitis Study Group. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring. Clin Exp Allergy. 2002 Jul;32(7):1020-8. doi: 10.1046/j.1365-2222.2002.01422.x. Erratum In: Clin Exp Allergy. 2009 Oct;39(10):1622.

Study record dates

Study Major Dates

• Study Start: March 1, 2000
• Primary Completion (ACTUAL): May 1, 2000
• Study Completion (ACTUAL): May 1, 2000

Study Registration Dates

• First Submitted: September 17, 2009
• First Submitted That Met QC Criteria: September 17, 2009
• First Posted (ESTIMATE): September 18, 2009

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Montelukast; Loratadine
• Other Study ID Numbers: 0476A-162; MK0476A-162; 2009_664