Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

NCT00972738 | Completed Phase 3 Results

• 3 other identifiers: 0476-235MK0476-2352009_658
• Study Type: interventional
• Target: 1,214
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period

  Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale \[Score 0 (best) to 3 (worst)\]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.

  Baseline and over the 2-week treatment period

Secondary Outcomes (5)

• Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period

  Baseline and over the 2-week treatment period

• Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period

  Baseline and over the 2-week treatment period

• Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period

  End of the 2-week treatment period

• Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period

  End of the 2-week treatment period

• Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period

  Baseline and at the end of 2-week treatment period

Study Arms (3)

1

EXPERIMENTAL

montelukast

Drug: montelukast sodium

2

ACTIVE COMPARATOR

loratadine

Drug: Comparator: loratadine

3

PLACEBO COMPARATOR

placebo

Drug: Comparator: Placebo

Interventions

montelukast sodium DRUG

Montelukast 10-mg tablet orally once daily at bedtime for 2 weeks.

1

Comparator: loratadine DRUG

Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.

2

Comparator: Placebo DRUG

placebo tablet orally once daily at bedtime for 2 weeks

3

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 season allergic rhinitis symptoms that flare up during the study season
• Patient is a nonsmoker
• Patient is in good general health

You may not qualify if:

• Patient is hospitalized
• Patient is a woman who is \<8 weeks postpartum or is breast-feeding
• Patient has had major surgery in the past 4 weeks
• Patient intends to move or vacation away during the study
• Patient is a current or past abuser of alcohol or illicit drugs

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• van Adelsberg J, Philip G, LaForce CF, Weinstein SF, Menten J, Malice MP, Reiss TF; Montelukast Spring Rhinitis Investigator Group. Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2003 Feb;90(2):214-22. doi: 10.1016/S1081-1206(10)62144-8.

  PMID: 12602669 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

In the paper patients who withdrew for worsening allergic rhinitis/conjunctivitis were included under category of discontinued due to lack of efficacy rather than discontinued due to clinical Adverse Events

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 4, 2009
• First Posted: September 7, 2009
• Study Start: April 1, 2001
• Primary Completion: July 1, 2001
• Study Completion: July 1, 2001
• Last Updated: February 3, 2022
• Results First Posted: June 16, 2010

Record last verified: 2022-02