Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

Deborah Gentile84 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Upper Respiratory Infection

Interventions

MontelukastDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Nasal Secretion Weights

Time frame: 6 days after naturally acquiring an upper respiratory infection

Data from ClinicalTrials.gov

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