The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)

NCT00092118 | Completed Phase 3 Results

• 3 other identifiers: 0476-265MK0476-2652004_018
• Study Type: interventional
• Target: 1,992
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis

  Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale \[Score 0 (best) to 3 (worst)\].

  6 week treatment period (from baseline though the end of week 6)

Secondary Outcomes (2)

• Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period

  At the end of the 6 week treatment period

• Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period

  Baseline and Week 6

Study Arms (2)

1

EXPERIMENTAL

Montelukast

Drug: Montelukast

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

Interventions

Montelukast DRUG

one 10 mg tablet, taken once daily at bed time for 6 weeks

1

Comparator: Placebo DRUG

one placebo tablet, taken once daily at bed time for 6 weeks

2

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:

• Non-smoker with a 2-year documented history of perennial allergic (symptoms that persist throughout the year) rhinitis symptoms and positive allergy testing

You may not qualify if:

• Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Patel P, Philip G, Yang W, Call R, Horak F, LaForce C, Gilles L, Garrett GC, Dass SB, Knorr BA, Reiss TF. Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2005 Dec;95(6):551-7. doi: 10.1016/S1081-1206(10)61018-6.

  PMID: 16400895 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

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 21, 2004
• First Posted: September 24, 2004
• Study Start: October 1, 2003
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: February 3, 2022
• Results First Posted: July 23, 2010

Record last verified: 2022-02