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CompletedNCT00092105Updated Aug 14, 2024

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

A Phase 3 interventional study of MK0476, montelukast sodium and Comparator: placebo in Asthma, Bronchial and Rhinitis, Allergic, Perennial, sponsored by Organon and Co. Completed. Open to participants aged 15 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Organon and Co · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Apr 2002, registered Sep 2004).
Phase
Phase 3
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
15 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

The duration of treatment is 2 weeks.

02

Conditions studied

  • Asthma, Bronchial
  • Rhinitis, Allergic, Perennial

Keywords

  • Rhinitis, Allergic
03

In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 58 is below the median of 83 across 2,814 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
58 participants (actual)

Interventions

06

What researchers measure

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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 15562881 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00092105
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Sep 24, 2004
Start date
Apr 1, 2002
Primary completion
Jan 1, 2003
Completion
Jan 28, 2003
Last update
Aug 14, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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