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

NCT ID: NCT00963599

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 907 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 1999-11-30

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.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

montelukast/loratadine

Group Type: EXPERIMENTAL

Comparator: montelukast/loratadine

Intervention Type: DRUG

montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks

2

loratadine

Group Type: EXPERIMENTAL

Comparator: loratadine

Intervention Type: DRUG

loratadine 10 mg tablet taken once daily at bed time for 2 weeks

3

montelukast

Group Type: EXPERIMENTAL

Comparator: montelukast

Intervention Type: DRUG

montelukast 10 mg tablet taken once daily at bed time for 2 weeks

4

placebo

Group Type: PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type: DRUG

placebo tablet taken once daily at bed time for 2 weeks

Interventions

Comparator: montelukast/loratadine

montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks

Intervention Type: DRUG

Comparator: montelukast

montelukast 10 mg tablet taken once daily at bed time for 2 weeks

Intervention Type: DRUG

Comparator: loratadine

loratadine 10 mg tablet taken once daily at bed time for 2 weeks

Intervention Type: DRUG

Comparator: placebo

placebo tablet taken once daily at bed time for 2 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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. doi: 10.1016/S1081-1206(10)61891-1.

Reference Type: RESULT

PMID: 12086367 (View on PubMed)

Other Identifiers

MK0476A-117

Identifier Type: -

Identifier Source: secondary_id

2009_645

Identifier Type: -

Identifier Source: secondary_id

0476A-117

Identifier Type: -

Identifier Source: org_study_id