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

NCT00979901 | Completed Phase 3 Results

• 3 other identifiers: 0476A-162MK0476A-1622009_664
• Study Type: interventional
• Target: 1,577
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks

  Baseline and Week 2

• Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks

  Baseline and Week 2

• Patient's Global Evaluation of Allergic Rhinitis at Week 2

  Week 2

• Physician's Global Evaluation of Allergic Rhinitis at Week 2

  Week 2

• Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2

  Week 2

Study Arms (4)

1

EXPERIMENTAL

montelukast

Drug: Comparator: montelukast

2

EXPERIMENTAL

loratadine

Drug: Comparator: loratadine

3

PLACEBO COMPARATOR

placebo

Drug: Comparator: placebo

4

EXPERIMENTAL

montelukast/loratadine

Drug: Comparator: montelukast/loratadine

Interventions

Comparator: montelukast DRUG

10 mg montelukast tablet given once daily at bedtime for 2 weeks

1

Comparator: loratadine DRUG

10 mg loratadine tablet given once daily at bedtime for 2 weeks

2

Comparator: placebo DRUG

placebo tablet given once daily at bedtime for 2 weeks

3

Comparator: montelukast/loratadine DRUG

montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks

4

Eligibility Criteria

• Age: 15 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 12100048 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Loratadine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

Montelukast/loratadine arm was discontinued due to business decision by sponsor to focus development on montelukast monotherapy. There was no efficacy data reported for this treatment arm.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: March 1, 2000
• Primary Completion: May 1, 2000
• Study Completion: May 1, 2000
• Last Updated: February 9, 2022
• Results First Posted: June 8, 2010

Record last verified: 2022-02