Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

• ClinicalTrials.gov Identifier: NCT00963599
• Recruitment Status: Completed
• First Posted: August 21, 2009
• Results First Posted: June 16, 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 oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 907 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 Effect of Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study
• Study Start Date: September 1999
• Actual Primary Completion Date: November 1999
• Actual Study Completion Date: November 1999

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; montelukast/loratadine	Drug: Comparator: montelukast/loratadine; montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks
Experimental: 2; loratadine	Drug: Comparator: loratadine; loratadine 10 mg tablet taken once daily at bed time for 2 weeks
Experimental: 3; montelukast	Drug: Comparator: montelukast; montelukast 10 mg tablet taken once daily at bed time for 2 weeks
Placebo Comparator: 4; placebo	Drug: Comparator: placebo; placebo tablet taken once daily at bed time for 2 weeks

Outcome Measures

Primary Outcome Measures :

1. Mean Change From Baseline in Daytime Nasal Symptoms Score [ 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 (0 (best) to 3 (worst)). The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.

Secondary Outcome Measures :

1. Mean Change From Baseline in Nighttime Symptoms Score [ 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 (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
2. Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) [ Time Frame: Baseline and Week 2 ]
   Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)).
3. Mean Change From Baseline in Daytime Eye Symptoms Score [ 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 symptom 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.
4. Mean Change From Baseline in Daytime Nasal Congestion Score [ Time Frame: Baseline and Week 2 ]
   Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)).
5. Mean Change From Baseline in Daytime Rhinorrhea Score [ Time Frame: Baseline and Week 2 ]
   Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)).
6. Mean Change From Baseline in Daytime Nasal Itching Score [ Time Frame: Baseline and Week 2 ]
   Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)).
7. Mean Change From Baseline in Daytime Sneezing Score [ Time Frame: Baseline and Week 2 ]
   Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)).
8. Mean Change From Baseline in Nasal Congestion Upon Awakening [ Time Frame: Baseline and Week 2 ]
   Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)).
9. Patient's Global Evaluation of Allergic Rhinitis [ 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. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
10. Physician's Global Evaluation of Allergic Rhinitis [ 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. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse).
11. Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score [ Time Frame: 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: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.

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
• 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
• Patient has any active pulmonary disorder other than asthma

Contacts and Locations

Sponsors and Collaborators

Organon and Co

Investigators

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

More Information

Publications of Results:

Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol. 2002 Jun;88(6):592-600.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00963599
• Other Study ID Numbers: 0476A-117; MK0476A-117; 2009_645
• First Posted: August 21, 2009
• Results First Posted: June 16, 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