Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)

Rhinitis, Allergic, Perennial Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Crossover Study Investigating the Clinical Effect of Montelukast in Patients With Concomitant Asthma and Allergic Rhinitis Upon Controlled Exposure to Cat Allergen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00092105
• Other study ID #: 0476-256
• Secondary ID: 2004_024
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2002
• Est. completion date: January 28, 2003

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The duration of treatment is 2 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 28, 2003
• Est. primary completion date: January 1, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Asthma
• Asthma, Bronchial
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• MK0476, montelukast sodium

• Comparator: placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	(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.