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

• ClinicalTrials.gov Identifier: NCT00979901
• Recruitment Status: Completed
• First Posted: September 18, 2009
• Results First Posted: June 8, 2010
• Last Update Posted: February 9, 2022
• Sponsor: Organon and Co
• Information provided by (Responsible Party): Organon and Co

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Seasonal Allergic Rhinitis	Drug: Comparator: montelukast; Drug: Comparator: loratadine; Drug: Comparator: placebo; Drug: Comparator: montelukast/loratadine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1577 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Seasonal Allergic Rhinitis--Spring Study
• Study Start Date: March 2000
• Actual Primary Completion Date: May 2000
• Actual Study Completion Date: May 2000

Arms and Interventions

Arm	Intervention/treatment
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
Placebo Comparator: 3; placebo	Drug: Comparator: placebo; placebo 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

Outcome Measures

Primary Outcome Measures :

1. Mean Change From Baseline in Daytime Nasal Symptoms Score Over 2 Weeks [ 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. 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).

Secondary Outcome Measures :

1. Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks [ 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, 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).

2. Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks [ 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 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).

3. Patient's Global Evaluation of Allergic Rhinitis at Week 2 [ 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. Scores were measured as 0 (best) to 6 (worst).

4. Physician's Global Evaluation of Allergic Rhinitis at Week 2 [ 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. Scores were measured as 0 (best) to 6 (worst).
5. Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2 [ Time Frame: 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).

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 85 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Organon and Co

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Publications of Results:

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. Erratum in: Clin Exp Allergy. 2009 Oct;39(10):1622.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00979901
• Other Study ID Numbers: 0476A-162; MK0476A-162; 2009_664
• First Posted: September 18, 2009
• Results First Posted: June 8, 2010
• Last Update Posted: February 9, 2022
• Last Verified: February 2022

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Loratadine; Montelukast; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action; Antipruritics; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents