NCT00189475

Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

A Pilot Study to Evaluate the Potential of Montelukast to Prevent the Development of Nasal Symptomatology During Natural Viral Upper Respiratory Infections

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Deborah Gentile · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized double-blinded placebo controlled trial to assess 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. All subjects complete daily assessments of cold symptoms, nasal clearance rates and secretion rates during each day of the study. Phlebotomy is performed once for the determination of cytokine genotyping and allergy skin testing is performed once for the assessment of atopy.

Conditions

• Upper Respiratory Infection

Interventions

Type	Name	Description
DRUG	Montelukast
DRUG	Placebo

Timeline

• Start date: 2003-10-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2005-09-19
• Last updated: 2020-11-18
• Results posted: 2014-10-17

Locations

1 site across 1 country: United States