NCT00092105

Brief Summary

The purpose of this study is to determine the protective effect of an approved medication on asthma and allergic rhinitis (inflammation of the mucous membrane of the nose) upon exposure to cats.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2003

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2004

Completed
Last Updated

August 14, 2024

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

September 21, 2004

Last Update Submit

August 12, 2024

Conditions

Asthma, BronchialRhinitis, Allergic, Perennial

Keywords

Rhinitis, Allergic

Outcome Measures

Primary Outcomes (1)

  • Co-Primary endpoints: (1) Area Under the Curve (AUC) for the percent fall from prechallenge FEV1 during allergen challenge; (2) Area Under the Curve for the increase from prechallenge Nasal Symptoms score during allergen challenge

Secondary Outcomes (1)

  • (1) Maximum percent fall from prechallenge FEV1; (2) AUC for the increase from prechallenge Chest Symptoms score (3) AUC for the increase from prechallenge Nasal Symptoms score collected over 60 minutes after terminating the challenge.

Interventions

MK0476, montelukast sodiumDRUG
Comparator: placeboDRUG

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Increased sensitivity to cat allergen proven by positive allergy testing, and by decreased lung function and increased symptoms of allergic rhinitis (runny nose) upon exposure to cats.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Perry TT, Corren J, Philip G, Kim EH, Conover-Walker MK, Malice MP, Massaad R, Dass SB, Reiss TF, Wood RA. Protective effect of montelukast on lower and upper respiratory tract responses to short-term cat allergen exposure. Ann Allergy Asthma Immunol. 2004 Nov;93(5):431-8. doi: 10.1016/S1081-1206(10)61409-3.

    PMID: 15562881BACKGROUND

MeSH Terms

Conditions

AsthmaRhinitis, Allergic, PerennialRhinitis, Allergic

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2004

First Posted

September 24, 2004

Study Start

April 1, 2002

Primary Completion

January 1, 2003

Study Completion

January 28, 2003

Last Updated

August 14, 2024

Record last verified: 2022-02