Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deborah Gentile; West Penn Allegheny Health System
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Montelukast

Criteria

Inclusion Criteria:

• Adults 18 to 50 years of age.

• Male or female, who are not pregnant or lactating.

• Common cold symptoms for less than 24 hours.

• At least 2 of the following 9 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratch throat, sneezing and malaise.

Exclusion Criteria:

• Investigational medication in past 30 days.

• Known hypersensitivity to any ingredients in study medication.

• History of asthma or other chronic diseases.

• Females of childbearing potential who are not using a medically acceptable form of birth control.

• Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction.

• Females with a positive urinary HCG test.

• Patients with a positive rapid antigen test for streptococcal infection.

• Common cold symptoms for more than 24 hours.

• Patients who are users of illicit drugs.

• Patients who are on rifampin or phenobarbital.